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BHI Weekly News Archives

664th Edition, July 8, 2025

By BHI Weekly News Archives
Reimagining Gene and Cell Therapy: Helen Sabzevari on Precigen’s Breakthroughs in Precision Medicine on BioTalk
In this episode of BioTalk, Rich Bendis welcomes Dr. Helen Sabzevari, President and CEO of Precigen, to discuss the company’s cutting-edge science in gene and cell therapy. Dr. Sabzevari shares how Precigen’s unique AdenoVerse® platform has powered the development of PRGN-2012, a potential first-in-class therapeutic currently under FDA priority review for the treatment of adults with recurrent respiratory papillomatosis (RRP), a rare and devastating disease. She also highlights advances across Precigen’s broader pipeline in immuno-oncology and autoimmune disease and reflects on how Maryland’s BioHealth Capital Region has supported the company’s innovation and growth.Listen now on your favorite podcast platform:
Apple: https://apple.co/3IdIAPi
Spotify: https://bit.ly/4eKJIGo
iHeart: https://ihr.fm/4krFxAy
YouTube: https://bit.ly/4lnRUPq
Amazon Music: https://amzn.to/4nG3Tt6
TuneIn: https://bit.ly/4lqEaTG

Editing and post-production work for this episode was provided by The Podcast Consultant.

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Connect Capital and Innovation at the BioHealth Capital Region Investment Conference on September 25, 2025 at US Pharmacopeia, Rockville, MD
The Annual BioHealth Capital Region Investment Conference is the premier destination for discovering emerging companies that are redefining what’s possible in life sciences.Taking place on Thursday, September 25, the final day of BioHealth Capital Region Week 2025, the conference brings together startups, growth-stage companies, VCs, strategics, and innovation scouts for a dynamic day of curated pitches, one-on-one meetings, and strategic networking — all hosted at US Pharmacopeia in Rockville, Maryland.

For Investors:

This is where you’ll find what’s next. The conference showcases a vetted lineup of companies spanning therapeutics, diagnostics, digital health, AI-powered solutions, and other transformative technologies. You’ll hear live pitch presentations and quick-pitches on the main stage from top applicants,  including standout participants from the previous day’s Crab Trap Competition.

Investors will schedule targeted meetings with presenting companies and engage with the region’s leading commercialization partners, accelerators, and research institutions. Whether you’re looking to make your next investment or build your pipeline, this is one of the best opportunities of the year to do it.

Investor registration is open now:
https://bit.ly/BHCRIC2025

For Startups and Entrepreneurs:

The Investment Conference is designed for companies ready to raise capital or build relationships with the investors who matter most in the BioHealth space. Whether you’re seeking Seed, Series A, or strategic partnerships, this event puts you directly in front of potential funders and collaborators.

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Registration Now Open for the 11th Annual BioHealth Capital Region Week

BioHealth Capital Region Week returns for its 11th year, and registration is now officially open. Scheduled for September 23–25, 2025, this annual gathering will once again take place at US Pharmacopeia (USP) in Rockville, Maryland, bringing together leaders from across the biohealth ecosystem for three days of innovation, connection, and forward-thinking dialogue.

This year’s theme—“Where Human and Artificial Intelligence Converge in the BioHealth Industry”—will guide Forum discussions as experts from across industry, government, and academia explore how AI is reshaping drug development, diagnostics, health data, and the future of care delivery.

Sponsorship opportunities are still available at multiple levels, including standard, lunch, networking reception, VIP dinner, and display table options. Sponsors receive prominent visibility throughout the event and exclusive access to the region’s top biohealth leaders.

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Apply Now for the BioHealth Capital Region Crab Trap Competition

Applications are now open for the 9th Annual Crab Trap Competition, one of the signature events of BioHealth Capital Region Week 2025, taking place on Wednesday, September 24, during Day 2 of the BioHealth Capital Region Forum at US Pharmacopeia (USP) in Rockville, Maryland.

The Crab Trap showcases emerging startups developing high-impact innovations in therapeutics, diagnostics, medical devices, digital health, and other transformative areas of healthcare. Finalists will pitch live to a panel of expert judges in front of a high-profile audience of industry leaders, investors, and commercialization partners.

The winning company will receive a valuable package of services and recognition to help accelerate its growth.

Click here to apply to compete in the Crab Trap.

Deadline to apply: AUGUST 29, 2025

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Pediatrix Appoints Former Children’s National CEO and Former BHI Board Member Dr. Kurt Newman to Board of Directors
FORT LAUDERDALE, Fla.–(BUSINESS WIRE)–Pediatrix Medical Group, Inc. (NYSE: MD), a leading provider of physician services, today announced that its board of directors has appointed Kurt D. Newman, M.D., former President and Chief Executive Officer of Children’s National Hospital in Washington, D.C. and Professor Emeritus of Surgery and Pediatrics at George Washington University School of Medicine and Health Sciences, as an independent director, effective July 1, 2025.Dr. Newman, a surgeon and nationally recognized leader in pediatric healthcare and a long-term healthcare executive, served as President and Chief Executive Officer of Children’s National Hospital for 12 years, after spending over 25 years there as a pediatric surgeon. Dr. Newman fostered a culture of patient-centered care and championed a culture of innovation in research, operations and clinical care. Dr. Newman is a strong advocate for expanding mental health access for children and has led two national forums on this issue. He is the author of a best-selling book, “Healing Children: a Surgeon’s Stories from the Frontiers of Pediatric Medicine.” Dr. Newman was recognized as “CEO of the Year” by the Washington Business Journal in 2021 and inducted into the Washington Business Hall of Fame in 2023.

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George Mason is part of Northern Virginia’s first innovation district, launched with transformational grant from GO Virginia
Thanks to a major investment from GO Virginia, Northern Virginia’s first Innovation District is taking shape, laying the groundwork for growth in high-tech industry sectors like life sciences, aerospace, defense, and semiconductors.Governor Glenn Youngkin announced last week that the commonwealth will invest $2.6 million into Northern Virginia’s first Innovation District, with an additional $1.3 million coming from local businesses, government, and higher education partners. The funding will help launch the Innovation District and roll out programs aimed at making Northern Virginia a national hub for research-driven industries, while giving residents the chance to pursue strong, lasting careers without leaving their communities.

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Maryland Tech Council Launches Rural Technology Network to Accelerate Rural Innovation
ROCKVILLE, Md.–(BUSINESS WIRE)–The Maryland Tech Council (MTC), the largest technology and life sciences trade association in the state, today announced the launch of the Rural Technology Network, a new initiative to accelerate growth in rural Maryland’s technology ecosystem.The Rural Technology Network will strengthen economic growth in rural Maryland through strategic business development and by offering companies enhanced access to networking, cost savings, education, mentorship and other resources. It also seeks to foster partnerships between the private sector, educational institutions, and local governments to enhance commercialization and grow the pipeline of local businesses and talent.

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Gain Therapeutics Completes Enrollment for Parkinson’s Drug Study
BETHESDA, Md., June 30, 2025 (GLOBE NEWSWIRE) — Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today provided an update on the progress of its ongoing Phase 1b clinical study evaluating the safety and tolerability of GT-02287 in people with Parkinson’s Disease with or without a GBA1 mutation. The study, which aimed to enroll 15-20 participants, reached 16 participants on June 30th, 2025.

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663rd Edition, July 1, 2025

By BHI Weekly News Archives

Apply Now for the BioHealth Capital Region Crab Trap Competition

Applications are now open for the 9th Annual Crab Trap Competition, one of the signature events of BioHealth Capital Region Week 2025, taking place on Wednesday, September 24, during Day 2 of the BioHealth Capital Region Forum at US Pharmacopeia (USP) in Rockville, Maryland.

The Crab Trap showcases emerging startups developing high-impact innovations in therapeutics, diagnostics, medical devices, digital health, and other transformative areas of healthcare. Finalists will pitch live to a panel of expert judges in front of a high-profile audience of industry leaders, investors, and commercialization partners.

The winning company will receive a valuable package of services and recognition to help accelerate its growth.

Click here to apply to compete in the Crab Trap.

Deadline to apply: AUGUST 29, 2025

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Navigating FDA Disruption: Insights from BHI EIR Kwame Ulmer

In a new video feature, BioHealth Innovation’s Entrepreneur-in-Residence (EIR) Kwame Ulmer offers a candid and experienced take on the evolving FDA landscape and its impact on medical device innovation.

As Managing Partner at MedTech Impact Partners, Kwame brings more than two decades of regulatory expertise to the table. His experience includes twelve years in leadership roles at the FDA, culminating as Deputy Director and Branch Chief, where he personally evaluated over 1,000 medical technologies. Today, he advises startups on regulatory strategy, supports complex submissions including de novo, PMA, and 510(k), and helps medtech founders navigate an increasingly uncertain regulatory environment.

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Registration Now Open for the 11th Annual BioHealth Capital Region Week

BioHealth Capital Region Week returns for its 11th year, and registration is now officially open. Scheduled for September 23–25, 2025, this annual gathering will once again take place at US Pharmacopeia (USP) in Rockville, Maryland, bringing together leaders from across the biohealth ecosystem for three days of innovation, connection, and forward-thinking dialogue.

This year’s theme—“Where Human and Artificial Intelligence Converge in the BioHealth Industry”—will guide Forum discussions as experts from across industry, government, and academia explore how AI is reshaping drug development, diagnostics, health data, and the future of care delivery.

Sponsorship opportunities are still available at multiple levels, including standard, lunch, networking reception, VIP dinner, and display table options. Sponsors receive prominent visibility throughout the event and exclusive access to the region’s top biohealth leaders.

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Emergent Secures $62.4M Contract Boost for Botulism Antitoxin to Support U.S. Biodefense

GAITHERSBURG, Md., June 23, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced it has been awarded a $62.4 million contract modification from the Administration for Strategic Preparedness and Response (ASPR), a division of the United States Department of Health and Human Services (HHS) for BAT® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)]. The modification has been made to the existing 10-year contract with ASPR (75A50119C00075) whereby Emergent will supply BAT®, an antitoxin used in the treatment of symptomatic botulism following suspected or confirmed exposure to botulinum neurotoxin serotypes A, B, C, D, E, F, or G in both adults and pediatric patients.

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Altimmune Announces Positive Topline Results from the IMPACT Phase 2b Trial of Pemvidutide in the Treatment of MASH

GAITHERSBURG, Md., June 26, 2025 (GLOBE NEWSWIRE) —  Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced positive topline results from the IMPACT Phase 2b trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH).

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UVA Health: Additional $50 million raised for Manning Institute of Biotechnology

UVA Health has received two anonymous $25 million estate gifts to support the University of Virginia’s Paul and Diane Manning Institute of Biotechnology. The $50 million of additional support for the institute enabled UVA Health to top its $1 billion fundraising goal in UVA’s Honor the Future campaign, which concludes this month. 

“I’m deeply grateful for the generosity and vision of these donors, whose contributions will help us to realize the full potential of the Manning Institute, and for everyone who has helped UVA Health reach this milestone,” said UVA President Jim Ryan. “These extraordinary gifts will support the Manning Institute’s research and aid in developing new treatments for hard-to-treat or incurable diseases, which will change lives across the Commonwealth and beyond.”

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I-Mab Reports Promising Givastomig Phase 1b Results in First-Line Gastric Cancer

ROCKVILLE, Md., June 26, 2025 (GLOBE NEWSWIRE) — I-Mab (NASDAQ: IMAB) (the “Company”), a U.S.-based, global biotech company, focused on the development of precision immuno-oncology agents for the treatment of cancer, today announced publication of ESMO Gastrointestinal Cancers Congress 2025 (ESMO GI 2025) abstract #388MO related to positive data from a Phase 1b study evaluating givastomig in combination with nivolumab and mFOLFOX6 chemotherapy for metastatic gastric cancers. An objective response rate (ORR) of 71% (12/17) was observed across all dose levels with an ORR of 83% (10/12) observed at dose levels selected for the ongoing dose expansion study (8 and 12 mg/kg). Responses were rapid and deepened over time, and were observed in tumors with low levels of PD-L1 expression and/or low levels of Claudin 18.2 (CLDN18.2) expression. There was a favorable safety profile, with low incidence of GI and liver toxicities. I-Mab intends to host a virtual investor event on Tuesday, July 8th (register here) to recap the data being presented at ESMO GI.

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Aurinia Reports Strong Early Results for New Autoimmune Drug AUR200

ROCKVILLE, Md. & EDMONTON, Alberta–(BUSINESS WIRE)–Aurinia Pharmaceuticals Inc. (NASDAQ: AUPH) today announced positive results from a Phase 1 single-ascending-dose (SAD) study of aritinercept (AUR200), its dual inhibitor of B cell-activating factor (BAFF) and a proliferation-inducing ligand (APRIL). The study investigated aritinercept doses of 5 mg, 25 mg, 75 mg, 150 mg, 225 mg and 300 mg and placebo, administered by subcutaneous injection, in 61 healthy subjects.

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All Rights Reserved.

 
 

 

662nd Edition, June 24, 2025

By BHI Weekly News Archives

BHI and the BioHealth Capital Region Partners Showcase Our Great Assets at BIO 2025 in Boston

The 2025 BIO International Convention brought together over 20,000 life sciences leaders from across the globe. BioHealth Innovation, Inc. (BHI), led by Founder, President, and CEO Rich Bendis, was proud to represent both the organization and the broader BioHealth Capital Region (BHCR) during this year’s gathering in Boston.

As one of the most wide-ranging events in the biotech industry, BIO 2025 served as a platform to showcase the BioHealth Capital Region’s unique strengths. The region, encompassing Maryland, Washington, D.C., and Virginia, presented a united front of innovation and economic vitality. Maryland and Virginia each hosted pavilions that attracted strong traffic and engagement, while the District’s leadership was prominently involved in cross-jurisdiction conversations.

“There was a great deal of interaction between the members of the BHCR during the Convention and it culminated with the First Annual BHCR Breakfast on Wednesday the 18th,” said Bendis. “Virginia also had their own breakfast on Tuesday the 17th and Maryland had a well-attended evening reception that same day. These events made it clear just how committed the region is to growing together.”

The BioHealth Capital Region BIO Breakfast, hosted at Maryland Tech Council Member, Vertex Pharmaceuticals. The breakfast brought together stakeholders from all three jurisdictions, reaffirming a shared commitment to growing the region’s life sciences economy. The breakfast was headlined by a panel discussion including Harry Coker, Jr, Secretary, Maryland Department of Commerce; Derek Ford, President & CEO, Washington DC Economic Partnership; Rachel Rath, Head of JLABs @ Washington D.C., and Joe Benevento, CEO, Virginia Innovation Partnership Corporation. BHI’s Rich Bendis served as the moderator for this panel.

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Decentralizing Discovery: Lara Mangravite and the Mission of Digitalis Commons on BioTalk

In this episode of BioTalk, Lara Mangravite, PhD, Executive Director of Digitalis Commons, joins the conversation to explore how scientific research is shifting in the U.S., from centralized, institutional models to a more decentralized, innovation-driven landscape. She shares the mission of Digitalis Commons and explains how the organization is working at the intersection of technology, research, and public good to address systemic barriers in health and healthcare. Drawing from her recent article, “Notes on Catalyzing Health,” Lara discusses the growing role of independent research institutions, the challenges of fragmentation, and why this moment calls for new leadership models and public-interest partnerships that can drive coordinated, high-impact solutions.

Listen now on your favorite podcast platform:
Apple: https://apple.co/4jXJdK0
Spotify: https://spoti.fi/4jWAdVm
iHeart: https://ihr.fm/3G800vX
Amazon: https://amzn.to/3SZGR2g
YouTube: https://bit.ly/4k2hF6h
TuneIn: https://bit.ly/445al3F

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Registration Now Open for the 11th Annual BioHealth Capital Region Week

BioHealth Capital Region Week returns for its 11th year, and registration is now officially open. Scheduled for September 23–25, 2025, this annual gathering will once again take place at US Pharmacopeia (USP) in Rockville, Maryland, bringing together leaders from across the biohealth ecosystem for three days of innovation, connection, and forward-thinking dialogue.

This year’s theme—“Where Human and Artificial Intelligence Converge in the BioHealth Industry”—will guide Forum discussions as experts from across industry, government, and academia explore how AI is reshaping drug development, diagnostics, health data, and the future of care delivery.

Sponsorship opportunities are still available at multiple levels, including standard, lunch, networking reception, VIP dinner, and display table options. Sponsors receive prominent visibility throughout the event and exclusive access to the region’s top biohealth leaders.

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Maryland’s Lt. Governor Miller Leads Maryland Delegation at World’s Largest Biotech Conference

BOSTON, MA – This week, Maryland Lt. Governor Aruna K. Miller led a Maryland delegation to the BIO International Convention in Boston, Massachusetts where she and members of the Department of Commerce promoted Maryland as a national hub for life sciences. 

The BIO International Convention is the world’s largest biotech industry event, bringing together leaders from more than 60 countries across the global biotechnology ecosystem—including biopharma companies, academic institutions, startups, investors, and government officials—to share insights, build partnerships, and showcase innovation. 

Maryland was among the most well-represented states at the convention as Lt. Governor Miller and Commerce Secretary Harry Coker, Jr. were joined by County Executives Marc Elrich and Jessica Fitzwater, Maryland Tech Council CEO Kelly Schulz, a delegation of 15 Maryland-based life sciences startup companies, and several other public and private sector leaders. 

“Maryland is America’s biotech frontier,” said Lt. Governor Miller. “This week we were proud to showcase why 5,000 life science companies call our state home and why Maryland is a place where potential meets performance, and innovation meets mission. With one of the most robust pipelines for STEM talent in the country and unmatched assets like our universities and life sciences sector, we’re not just keeping pace, we’re setting the standard.” 

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TEDCO Invests in Astek Diagnostics

COLUMBIA, Md., (June 17, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $500,000 dual investment in Astek Diagnostics, a biomedical company. This investment came from both the Pre-Seed Builder Fund, part of TEDCO’s Social Impact Funds, which supports Maryland’s underrepresented startup communities, and the Venture Funds, dedicated to funding and growing the next generation of early-stage businesses in the state.

Astek Diagnostics, based in Baltimore, Md., is a medical technology company working to transform infectious disease management through its Jiddu™ Platform—a diagnostic system that aims to deliver antibiotic susceptibility results in under one hour. Designed to support faster, more targeted treatment decisions, the platform addresses infections such as urinary tract infections (UTIs), sepsis and wound infections. Unlike traditional culture-based methods, which take 48 to 72 hours, Astek’s phenotypic approach aims to provide results at the point of care, hopefully reducing wait times without compromising precision.

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Infinity Bio Closes $8M Series A Financing Led by Illumina Ventures to Expand Leadership in Antibody Reactome Profiling

BALTIMORE–(BUSINESS WIRE)–Infinity Bio, a biotechnology company pioneering technologies to map immune responses at scale, today announced the successful closing of an $8 million Series A financing round. The round was led by Illumina Ventures, with participation from PTX Capital, Blackbird BioVentures, and Propel Baltimore Fund.

As part of the strategic plan to broaden its suite of service offerings, Infinity Bio has acquired the assets of Serimmune, Inc., which was founded in 2014 to provide unbiased antibody reactome services. New MIPSA™ service offerings, including EnviroSIGHT™, are also expected to launch in the second half of 2025.

Infinity Bio will use the proceeds to expand its commercial footprint, accelerate development of its proprietary MIPSA™ platform, and launch new immune profiling services. The platform enables unbiased, high-resolution analysis of the antibody reactome, an emerging field critical to understanding immune responses in health and disease.

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ReGelTec Announces First Patient Treated in U.S. IDE Clinical Trial for HYDRAFIL System to Treat Chronic Low Back Pain

BALTIMORE–(BUSINESS WIRE)–ReGelTec Inc., a company developing a percutaneous hydrogel implant for the treatment of chronic low back pain caused by degenerative disc disease, announced it has treated the first patient in its HYDRAFIL-D FDA investigational device exemption (IDE) clinical trial for its HYDRAFIL® System for disc augmentation. The patient was enrolled by Kas Amirdelfan, M.D., an interventional pain physician and founding member of Boomerang Healthcare, Inc. in Walnut Creek, Calif. The HYDRAFIL System is an outpatient procedure offering interventional pain physicians and patients a new treatment designed to reduce pain and improve daily function without the need for an invasive surgery.

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Processa Pharmaceuticals Signs Binding Term Sheet Granting Intact Therapeutics Exclusive Option to License Phase 2 Gastroparesis Drug Candidate

HANOVER, Md., June 17, 2025 (GLOBE NEWSWIRE) — Processa Pharmaceuticals, Inc. (Nasdaq: PCSA), today announced that it has entered into a binding term sheet with Intact Therapeutics, Inc. (“Intact”) granting Intact the exclusive option to license PCS12852, a best-in-class 5-HT4 receptor agonist with the potential to become a first meaningful treatment for gastroparesis and other gastrointestinal motility disorders.

Under the terms of the agreement, Processa is eligible to receive a $2.5 million option exercise fee, up to $20 million in development and regulatory milestone payments and over $432.5 million in commercial milestone payments based on net product sales. Intact will also pay Processa a double-digit royalty on worldwide net sales of licensed products, excluding South Korea, and provide Processa with an equity stake in Intact upon closing. Under the terms of its license, Processa must share 60% of any cash payments with its licensor (excluding the equity stake in Intact).

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VCU-born startup Evizia lands $2.2M NIH grant for commercialization of advanced DNA sequencing microscope

As DNA research enters a critical stage in next-generation sequencing, better methods are needed to visualize and study molecules.

Evizia, a company founded and based on technology developed by Jason Reed, Ph.D., a physics professor in the Virginia Commonwealth University College of Humanities and Sciences, has landed a $2.2 million grant from the National Human Genome Research Institute at the National Institutes of Health.

The “Direct to Phase II” Small Business Innovation Research grant will help Evizia optimize the manufacturing of its advanced microscope system that can benefit researchers with its novel method to visualize and study DNA molecules. Reed says the platform increases the quality of next-generation DNA sequencing and will support the development of new diagnostics and therapeutics.

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uBriGene Launches Clinical iPSC Banks to Accelerate Regenerative Medicine and Cell Therapy Development

ROCKVILLE, MD / ACCESS Newswire / June 16, 2025 / uBriGene Biosciences, a leading cell and gene therapy CDMO, is proud to announce the launch of its fully characterized, ready-to-use induced pluripotent stem cell (iPSC) banks. Developed using uBriGene’s proprietary RNA-LNP reprogramming technology, these iPSC banks are now available to support research, translational development, and clinical applications worldwide.

uBriGene’s iPSC seed banks and master cell banks (MCBs) are generated in GMP-compliant cleanrooms using healthy donor fibroblasts sourced from the USA in full compliance with FDA regulations. Reprogrammed with a non-integrating mRNA-LNP kit, the iPSCs are free of genomic footprint and residual RNA.

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NextCure and Simcere Zaiming Partner to Develop New Targeted Cancer Therapy

BELTSVILLE, Md. and SHANGHAI, June 16, 2025 (GLOBE NEWSWIRE) — NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class and best-in-class therapies to treat cancer, and Simcere Zaiming, an oncology-focused biopharmaceutical company and a subsidiary of Simcere Pharmaceutical Group Ltd (HKEX: 2096), today announced a strategic partnership to develop SIM0505, a novel antibody-drug conjugate (ADC) targeting CDH6 (cadherin-6 or K-cadherin) for the treatment of solid tumors. SIM0505 is currently in Phase 1 clinical testing in China; NextCure expects to begin clinical testing in the U.S. in the third quarter of 2025.

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Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

661st Edition, June 17, 2025

By BHI Weekly News Archives

Registration Now Open for the 11th Annual BioHealth Capital Region Week

BioHealth Capital Region Week returns for its 11th year, and registration is now officially open. Scheduled for September 23–25, 2025, this annual gathering will once again take place at US Pharmacopeia (USP) in Rockville, Maryland, bringing together leaders from across the biohealth ecosystem for three days of innovation, connection, and forward-thinking dialogue.

This year’s theme—“Where Human and Artificial Intelligence Converge in the BioHealth Industry”—will guide Forum discussions as experts from across industry, government, and academia explore how AI is reshaping drug development, diagnostics, health data, and the future of care delivery.

Sponsorship opportunities are still available at multiple levels, including standard, lunch, networking reception, VIP dinner, and display table options. Sponsors receive prominent visibility throughout the event and exclusive access to the region’s top biohealth leaders.

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Inside CTMC: Amy Hay on Reshaping Cell and Gene Therapy on BioTalk

In this episode of BioTalk, Amy C. Hay, Chief Business and Strategy Officer at the Cell Therapy Manufacturing Center (CTMC), joins the conversation to explore the evolving landscape of cell and gene therapy. Amy shares insights from her extensive career in oncology care and innovation, highlighting the role CTMC—a joint venture between National Resilience and MD Anderson Cancer Center—is playing in accelerating the transition from discovery to commercialization. She discusses the current state of the industry, what disruption really means in this context, and how new business models can drive stability and impact for early-stage biotech companies. Amy also offers her perspective on how manufacturing must evolve to meet clinical demand, and how CTMC is positioned to lead in this next era of therapeutic development.

Listen now via your favorite podcast platform:

Apple: https://apple.co/44dfCYa
Spotify: https://spoti.fi/45SJ3Qv
iHeart: https://ihr.fm/4k7Ck9b
YouTube: https://bit.ly/4jYZ23e
Amazon: https://amzn.to/4k7CoFX
TuneIn: https://bit.ly/3HyBF2X 

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Maryland’s Governor Moore Announces $6.95 Million in ‘Build Our Future’ Grant Awards to Support Innovation Infrastructure Development

ANNAPOLIS, MD — Governor Wes Moore today announced that the Maryland Department of Commerce has awarded 10 grants totaling $6.95 million through the Build Our Future Grant Pilot Program. The recipients represent projects that will support innovation infrastructure development in eligible technology sectors.

“Maryland will win the decade by making strategic investments in high-growth sectors,” said Gov. Moore. “The latest round of Build Our Future grants provides key infrastructure funding to projects supporting life sciences, clean tech, cybersecurity, and agriculture. Today’s announcement marks an important continuation of our longstanding work to grow our economy, create jobs, and leave no one behind.”

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TEDCO Invests in Higher Medicine

Maryland business researching treatment options for a debilitating illness

COLUMBIA, Md., (June 16, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $100,000 Pre-Seed Builder Fund investment in Higher Medicine. The Pre-Seed Builder Fund is housed under the Social Impact Funds, an umbrella of investment opportunities that seek to provide eligible entrepreneurs with access to support and capital.

“Kabuki syndrome is a rare genetic disorder in children that results in developmental delays, distinct facial features, and various medical complications throughout life,” said Leo Kim, Ph.D, founder and CEO of Higher Medicine. “We are looking to give hope to those impacted by developing a treatment that addresses the root causes, rather than symptomatic relief only. With TEDCO’s investment, we are excited to continue forward.”

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Supernus Pharmaceuticals to Acquire Sage Therapeutics, Strengthening its Neuropsychiatry Product Portfolio

ROCKVILLE, Md. and CAMBRIDGE, Mass., June 16, 2025 (GLOBE NEWSWIRE) — Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN) and Sage Therapeutics, Inc. (Nasdaq: SAGE), today announced a definitive agreement for Supernus to acquire Sage through a tender offer for $8.50 per share in cash (or an aggregate of approximately $561 million), payable at closing, plus one non-tradable contingent value right (CVR) collectively worth up to $3.50 per share in cash (or an aggregate of approximately $234 million), for total consideration of $12.00 per share in cash (or an aggregate of up to approximately $795 million). The CVR is payable upon achieving certain net sales and commercial milestones. The transaction is expected to close in the third quarter of 2025.

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BrainScope Expands Board and Launches Advanced Deep Learning Platform to Enhance Brain Health Insights

BETHESDA, Md.–(BUSINESS WIRE)–BrainScope®, a leader in AI-enabled EEG technology for brain health assessment, today announced the launch of its next-generation deep learning platform. BrainScope developed and has commercialized the first FDA-cleared AI/machine learning medical device in the field of neurology. Building on that foundation in machine learning, BrainScope’s new capabilities enhance its ability to deliver fast, objective, and clinically actionable insights across brain health conditions including concussion, stroke, and early Alzheimer’s detection.

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AllSci Wins Grant to Expand AI Platform for Pharma and Biotech R&D: Accelerating Hypothesis-Driven Discovery

NORTH BETHESDA, Md., June 11, 2025 /PRNewswire/ — AllSci, a pioneer in AI-driven tools for scientific research, has been awarded a grant from Montgomery County, Maryland’s Technology Innovation Fund – accelerating its mission of making science more accessible, connected, and collaborative. The grant supports AllSci’s continued development of its AI-powered research platform, empowering scientists at every level, from students to senior researchers, to formulate hypotheses, validate findings, and contribute to the scientific record, furthering its commitment to transforming the research process into one that is more open, intuitive, and inclusive.

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MaxCyte and Ori Biotech Team Up to Streamline Autologous Cell Therapy Manufacturing

ROCKVILLE, Md. and LONDON, June 11, 2025 (GLOBE NEWSWIRE) — MaxCyte, Inc. (Nasdaq: MXCT; LSE: MXCT), a leading, cell-engineering focused company providing enabling platform technologies to advance the discovery, development and commercialization of next-generation cell therapeutics, and Oribiotech Ltd. (Ori), a leader in advanced cell and gene therapy (CGT) manufacturing technology, today announced a strategic collaboration aimed at enhancing efficiency, scalability, and productivity in cell therapy manufacturing.

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Novavax’s Combo and Flu Vaccines Show Strong Immune Response in Early Phase 3 Trial

GAITHERSBURG, Md.June 11, 2025 /PRNewswire/ — Novavax, Inc. (Nasdaq: NVAX) today announced results of the initial cohort of its COVID-19-Influenza Combination (CIC) and stand-alone trivalent hemagglutinin nanoparticle seasonal influenza (tNIV) Phase 3 trial that showed both the CIC and flu vaccine candidates induced immune responses similar to licensed comparators Nuvaxovid® and Fluzone HD, respectively. This cohort was designed to provide descriptive data on three flu strains (H1N1, H3N2, B) and SARS-CoV-2 (COVID-19) to inform a future registrational Phase 3 program.

“Both our combination and stand-alone flu vaccine candidates induced robust immune responses and were well tolerated,” said Ruxandra Draghia-Akli, MD, PhD, Executive Vice President and Head of Research and Development, Novavax. “This data set adds to findings from our Phase 2 trial and will help inform discussions with potential partners.”

Read More

 
TEDCO Invests in NanoBioFAB

Medical device manufacturer looks to revolutionize wound care with AI-driven nanosensors

COLUMBIA, Md., (June 11, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced a recent $250,000 Pre-Seed Builder Fund investment in NanoBioFab. The Pre-Seed Builder Fund invests in and provides executive support to Maryland-based technology companies run by entrepreneurs who demonstrate economic disadvantages.

“We are excited to continue our business journey,” said Xiaonao Liu, Ph.D., CEO of NanoBioFAB. “TEDCO has been instrumental in our progress and success. Entrepreneurs looking to expand their business should look at the different opportunities that TEDCO offers.”

Read More

 

Vanda Pharmaceuticals Doses First Patient in Trial for CMT Type 2S Treatment

WASHINGTONJune 10, 2025 /PRNewswire/ — Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the first dose in the first-in-human clinical trial to evaluate the safety and tolerability of VCA-894A, an antisense oligonucleotide (ASO) therapeutic, for a patient with a rare variant in the IGHMBP2 gene causing Charcot-Marie-Tooth disease Type 2S (CMT2S).

Read More

 
 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

660th Edition, June 10, 2025

By BHI Weekly News Archives
 

Decoding Federal Dollars: Grant Engine CEO Sam Tetlow on the Evolving Biohealth Funding Map on BioTalk

In this episode of BioTalk, Sam Tetlow, Founder and CEO of Grant Engine, joins the conversation to share insights on how early-stage biotech and life science companies can navigate today’s complex federal funding environment. With a career spanning entrepreneurship, investment, and grant strategy, Sam breaks down what’s changed under the current administration, how companies should position themselves for success, and the durable tactics that still matter in securing SBIRs, ARPA-H contracts, and other non-dilutive awards. He also discusses the evolving priorities at HHS, the role of program officers, and how Grant Engine is adapting to help clients align with shifting agency goals. This episode builds on the upcoming June 10th, 2025 webinar co-hosted by Sam and BioHealth Innovation’s Rich Bendis, “Turning Uncertainty to Opportunity: Mastering Government Funding in 2025.” Learn more and register at: https://info.grantengine.com/turning-uncertainty-into-opportunity-mastering-government-funding-in-2025

Listen via your favorite podcast platform:
Apple – https://apple.co/4jEWGWO
Spotify – https://spoti.fi/3HIa5Qx
iHeart – https://ihr.fm/4dWwB4y
Amazon – https://amzn.to/4jELdqn
YouTube – https://bit.ly/3HHIwqA
TuneIn –  https://bit.ly/2M60Wmx

 

Read More

 
June 10, 2025 Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

 

USP announces new Advanced Technologies Laboratory in Maryland to accelerate and scale pharmaceutical manufacturing innovations

Lab will help enable broader adoption of advanced manufacturing technologies and state-of-the-art quality solutions 

Rockville, MD – June 4, 2025 – The U.S. Pharmacopeia (USP) announced today the opening of its Advanced Technologies Laboratory in Rockville, Maryland. USP will use this lab, and related solutions and expertise, to develop, pilot, and scale innovations that foster more efficient and expanded production of quality medicines for stronger and more secure supply chains. 

The lab expands USP capabilities to help manufacturers overcome barriers in the adoption of advanced manufacturing technologies by developing new approaches and processes for flow chemistry and additive manufacturing coupled with advanced analytical techniques such as process analytical technologies (PAT) that can enable real-time quality monitoring. The lab will also support development of alternative and novel synthetic routes to produce active pharmaceutical ingredients (APIs) and key starting materials. Taken together, these capabilities are essential in efforts to create stronger supply chains through strategic onshoring, distributed manufacturing, and personalized medicine. 

Read More

 
Previous BHCR Crab Trap Winner Luminoah Selected for Prestigious MedTech Innovator 2025 Accelerator Cohort

Charlottesville, VA – June 5, 2025 – Luminoah, a medical device company transforming chronic disease care through personalized enteral nutrition delivery, announced today that it has been selected to join the MedTech Innovator 2025 Accelerator Cohort. Luminoah is one of only 65 companies—representing the top 4% of nearly 1,500 global applicants—chosen for this year’s program.

MedTech Innovator (MTI) is the world’s largest accelerator for medical technology startups. The highly competitive four-month program provides participants with world-class mentorship, strategic guidance, and access to a robust network of investors, providers, payers, manufacturers, and industry experts.

“We are honored to join this year’s MedTech Innovator cohort,” said Neal Piper, Founder and CEO of Luminoah. “This opportunity gives us a powerful platform to validate our technology, accelerate key partnerships, and expand the reach of our mission to set a new standard in enteral nutrition.”

Read More

 

GlycoMimetics Stockholders Approve Proposed Merger with Crescent Biopharma and All Related Proposals

ROCKVILLE, Md.–(BUSINESS WIRE)–GlycoMimetics, Inc. (Nasdaq: GLYC) (“GlycoMimetics”) today announced that its stockholders have approved the proposed merger (the “Merger”) with Crescent Biopharma, Inc. (“Crescent”), along with all proposals related to the Merger. The proposals were voted upon at GlycoMimetics’ special meeting in lieu of the annual meeting of stockholders held on June 5, 2025 (the “Special Meeting”), including a reverse stock split of GlycoMimetics’ common stock to be effected at the discretion of the board of directors of GlycoMimetics (the “Board”) within the parameters approved by GlycoMimetics’ stockholders.

Read More

 
Maryland Stem Cell Research Fund Announces Call for Applications for the July 2025 Cycle

COLUMBIA, Md., June 4, 2025 /PRNewswire/ — The Maryland Stem Cell Research Commission (“Commission“) is pleased to announce the release of Requests for Applications (RFAs) for the July 2025 funding cycle. The deadline for application submissions is July 9, 2025.

The upcoming cycle supports a broad spectrum of grant programs, including early-stage basic research, translational efforts, clinical trials and manufacturing support. Maryland-based academic institutions, nonprofits and companies are encouraged to apply. Additionally, companies/non-profit entities outside Maryland are eligible to apply, provided the funded research occurs within the state. Supplemental funding is available for research projects involving collaboration between public and private sectors, accelerating the development of therapies for unmet medical needs.

Read More

 

IonQ Speeds Quantum-Accelerated Drug Development Application With AstraZeneca, AWS, and NVIDIA

COLLEGE PARK, Md.–(BUSINESS WIRE)–IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, announced results of a collaborative research program between IonQ, AstraZeneca, Amazon Web Services (AWS), and NVIDIA to develop and demonstrate a quantum-accelerated computational chemistry workflow which has the potential to power world-changing innovation in healthcare, life sciences, chemistry, and more.

Read More

 
NIH OTT’s Tara Kirby Selected as IAM Market Maker

The NIH Office of Technology Transfer Director, Dr. Tara Kirby, has been recognized by Intellectual Asset Management (IAM) as a Market Maker of the year. IAM’s Market Makers recognizes the top 40 key deal makers and decision takers in the world, as selected by the IAM editorial team. They consider who has driven major asset transactions, who has worked tirelessly to innovate in the dealmaking space and have engineered value from intellectual property.

Dr. Kirby was selected as #7 out of the list of 40 Market Makers. Included below is an excerpt from IAM’s article:

Read More

 

REGENXBIO Shares Promising Early Results from Gene Therapy Trial for Duchenne Muscular Dystrophy

ROCKVILLE, Md., June 5, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced new positive interim data from the Phase I/II AFFINITY DUCHENNE trial. Updates include positive functional, safety and biomarker data for RGX-202, REGENXBIO’s potential best-in-class, investigational gene therapy for Duchenne muscular dystrophy. The functional data demonstrate consistent benefit among dose level 2 participants at 9 and 12 months following treatment with RGX-202.

Read More

 
IonQ Completes Acquisition of Lightsynq, Accelerating Quantum Computing and Networking Roadmap

COLLEGE PARK, MD – June 3, 2025 – IonQ (NYSE: IONQ), a leading commercial quantum computing and networking company, today announced the successful completion of its acquisition of Lightsynq Technologies, Inc., a Boston-based startup specializing in photonic interconnects and quantum memory. This strategic acquisition accelerates IonQ’s fault-tolerant quantum computing roadmap and advances progress toward the development of the quantum internet.

Lightsynq’s photonic interconnect platform supports high-fidelity, multi-nodal qubit operations and modularity, which are essential for scaling quantum computers. The company’s innovations in quantum memory and repeater technology complement IonQ’s trapped-ion quantum computing approach and will advance IonQ’s quantum networking systems.

Read More

 

MacroGenics and Sagard Healthcare Partners Enter into ZYNYZ® Royalty Purchase Agreement

ROCKVILLE, MD, June 10, 2025 (GLOBE NEWSWIRE) — MacroGenics, Inc. (Nasdaq: MGNX), a clinical-stage biopharmaceutical company focused on discovering, developing, manufacturing and commercializing innovative antibody-based therapeutics for the treatment of cancer, today announced that it has entered into a royalty purchase agreement with Sagard in exchange for a capped royalty interest on future global net sales of ZYNYZ (retifanlimab-dlwr). ZYNYZ is a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte pursuant to an exclusive global collaboration and license agreement in October 2017. MacroGenics retains its other economic interests related to ZYNYZ, including future potential development, regulatory and commercial milestones. MacroGenics will also continue to support a portion of global commercial manufacturing needs for ZYNYZ.

Read More

 
Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

659th Edition, June 3, 2025

By BHI Weekly News Archives

 

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June 3, 2025

Banking with Heart: Rick Wieczorek on Financial Solutions for the Biohealth Community on BioTalk
In this episode of BioTalk, we welcome Rick Wieczorek, President and CEO of the NIH Federal Credit Union (NIHFCU), to discuss how credit unions like NIHFCU are uniquely positioned to support the biohealth and healthcare communities. With over 40 years of industry experience, Rick shares his journey from teller to CEO and reflects on NIHFCU’s 85-year history, its mission-driven approach to service, and the importance of tailoring financial solutions to meet the needs of life science professionals. He also explains the benefits of membership, the value of the NIHFCU “At Work” program for employers, and how the credit union’s “Banking with Heart” philosophy is making a difference across the BioHealth Capital Region.

Listen now via your favorite podcasting platform:
Apple –  https://apple.co/4jrwyi8
Spotify – https://spoti.fi/4km1v8L
iHeart – https://ihr.fm/3T0HZlY
Amazon – https://amzn.to/3FIwdts
YouTube – https://bit.ly/3T22kYd
TuneIn – https://bit.ly/3T8MgUt

Read More

June 10, 2025 Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

Cartesian Therapeutics Announces First Participant Enrolled in Phase 3 Trial of Descartes-08 for Myasthenia Gravis
FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

Read More

NIH OTT’s Tara Kirby Selected as IAM Market Maker
GERMANTOWN, Md., May 21, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the closing of its previously announced underwritten public offering of a total of 115,000,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase up to an additional 15,000,000 shares of common stock, at a public offering price of $0.50 per share.

The aggregate gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses were $57.5 million. All of the shares in the offering were sold by Senseonics.

Read More

Introducing the HJF-MDC Venture Fund: Fostering Medical Innovations for Military and Civilian Applications
Bethesda, Maryland – The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and MDC Studio, Inc (MDC) are proud to announce their groundbreaking collaboration through the HJF-MDC Venture Fund LLC.

This collaboration aims to revolutionize medical technology development and commercialization, benefiting military and civilian health care sectors.

The HJF-MDC Collaboration

This new initiative seeks to grow existing collaborations to accelerate the development and commercialization of dual-use medical technologies for military and civilian applications. As part of this initiative, MDC Studio has established a satellite office within HJF’s innovation facility in Bethesda, Maryland.

Introducing the HJF-MDC Venture Fund

HJF and MDC formed the HJF-MDC Venture Fund, as an independent entity that aims to invest in a diversified portfolio of early-stage companies commercializing military medical technologies with civilian applications. HJF is participating as a non-voting member of the Fund with a minority interest. The Fund’s focus areas include medical devices, wearables for health, and rehabilitation / assistive robotics. The Fund will be overseen by a Board of Managers, who will make investment decisions based on objective selection criteria, including alignment with military medical needs, benefits to civilian health, risks, and expected returns.

Read More

Bizjournals: Virginia Tech seeks industry partners for Institute for Advanced Computing
By Nate Doughty – Staff Reporter, Washington Business Journal – Virginia Tech this week unveiled the Institute for Advanced Computing at its Potomac Yard campus to offer academic and research opportunities in AI and quantum computing — and it’s looking for more companies to work with.

At buildout, the institute will employ 50 full-time faculty members and occupy about a third of Virginia Tech’s Academic Building One, a $302 million, 300,000-square-foot facility in Alexandria that opened in January. That’s all somewhat subject to grant funding, enrollment and the total number of partnerships, according to Kirk Cameron, professor of computer science at Virginia Tech and interim director of the institute.

Read More

Maryland Matters: Proposed Metro station development tied to growth of life sciences in Montgomery County
State and local leaders touted the promise of a proposed mixed-use development to be built over an existing North Bethesda Metro station as a way to grow Montgomery County’s burgeoning life sciences and tech industries.

The facility is still years away from breaking ground. But Montgomery County Executive Marc Elrich said the effort could transform the area into something similar to Kendall Square in Cambridge, Massachusetts, where technology firms are located close to MIT.

“I had been fascinated by the people I had been talking to about life sciences, and talking to me about Kendall Square in Boston, and talking about the urban campus, and talking about the value of collision spaces … rather than everything being done in office parks, where you never talk to the scientists in the next building,” Elrich said.

Read More

Danaher Announces Diagnostic Development and Commercialization Partnership to Scale Precision Medicine
WASHINGTON, May 29, 2025 /PRNewswire/ — Danaher Corporation (NYSE: DHR) (“Danaher”), a global science and technology innovator, announced today the launch of a partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments.

“Precision medicines are more targeted than standard therapies and thus require precision diagnostics to determine which patients are most likely to benefit,” said Julie Sawyer Montgomery, Danaher Executive Vice President. “We are excited to work with AstraZeneca on the goal of creating novel tests to increase access to precision medicines, helping ensure that no patients are left behind.”

Read More

FDA Grants RMAT Designation to AbelZeta’s C-CAR168 for Refractory Lupus
ROCKVILLE, Md., May 27, 2025 /PRNewswire/ — AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Read More

Baltimore’s Rapafusyn Selected for Roche Accelerator to Tackle Challenging Drug Targets
Baltimore, MD, May 27, 2025 —Rapafusyn Pharmaceuticals Inc., a leader in non-degrading molecular glues, announced today the joining of the Roche Accelerator, Roche’s innovation hub, which connects pioneering biotechs with Roche’s expertise.  Rapafusyn was selected to join the Roche Accelerator, based on Rapafusyn’s innovative RapaGlue™ platform and promising pipeline of potential first-in-class and best-in-class therapeutics.

Read More

 

Virginia Business: GO Virginia grant boosts biotech in Roanoke, New River Valley
Ralph Berrier Jr. //June 1, 2025// – A $4.9 million grant from the commonwealth will allow leaders from the  and New River valleys to build upon efforts by  Carilion School of Medicine and the Fralin Biomedical Institute at VTC to turn the region into a hub for .

“As we build the biotech sector, this statewide grant will help us where we have gaps,” explains Erin Burcham, CEO of the Roanoke Blacksburg Innovation Alliance (RBIA), a regional  organization.

The money is a slice of a $14.3 million pie from state economic development initiative  to fund the multiregional Project VITAL (Virginia Innovations and Technology Advancements in Life Sciences), an endeavor to make Virginia a biotechnology leader.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

659th Edition, June 3, 2025

By BHI Weekly News Archives

Banking with Heart: Rick Wieczorek on Financial Solutions for the Biohealth Community on BioTalk

In this episode of BioTalk, we welcome Rick Wieczorek, President and CEO of the NIH Federal Credit Union (NIHFCU), to discuss how credit unions like NIHFCU are uniquely positioned to support the biohealth and healthcare communities. With over 40 years of industry experience, Rick shares his journey from teller to CEO and reflects on NIHFCU’s 85-year history, its mission-driven approach to service, and the importance of tailoring financial solutions to meet the needs of life science professionals. He also explains the benefits of membership, the value of the NIHFCU “At Work” program for employers, and how the credit union’s “Banking with Heart” philosophy is making a difference across the BioHealth Capital Region.

Listen now via your favorite podcasting platform:
Apple –  https://apple.co/4jrwyi8
Spotify – https://spoti.fi/4km1v8L
iHeart – https://ihr.fm/3T0HZlY
Amazon – https://amzn.to/3FIwdts
YouTube – https://bit.ly/3T22kYd
TuneIn – https://bit.ly/3T8MgUt

Read More

 
June 10, 2025 Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

 

Cartesian Therapeutics Announces First Participant Enrolled in Phase 3 Trial of Descartes-08 for Myasthenia Gravis

FREDERICK, Md., May 30, 2025 (GLOBE NEWSWIRE) — Cartesian Therapeutics, Inc. (NASDAQ: RNAC) (“Cartesian” or the “Company”), a clinical-stage biotechnology company pioneering cell therapy for autoimmune diseases, today announced that the first participant has been enrolled in its Phase 3 AURORA trial of Descartes-08 in patients with myasthenia gravis (MG).

Descartes-08, Cartesian’s lead cell therapy candidate, is an autologous engineered chimeric antigen receptor T-cell therapy (CAR-T) product candidate targeting B-cell maturation antigen (BCMA). Descartes-08 is designed to be administered without preconditioning chemotherapy in an outpatient setting and does not use integrating vectors.

Read More

 
NIH OTT’s Tara Kirby Selected as IAM Market Maker

GERMANTOWN, Md., May 21, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the closing of its previously announced underwritten public offering of a total of 115,000,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase up to an additional 15,000,000 shares of common stock, at a public offering price of $0.50 per share.

The aggregate gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses were $57.5 million. All of the shares in the offering were sold by Senseonics.

Read More

 

Introducing the HJF-MDC Venture Fund: Fostering Medical Innovations for Military and Civilian Applications

Bethesda, Maryland – The Henry M. Jackson Foundation for the Advancement of Military Medicine, Inc. (HJF) and MDC Studio, Inc (MDC) are proud to announce their groundbreaking collaboration through the HJF-MDC Venture Fund LLC.

This collaboration aims to revolutionize medical technology development and commercialization, benefiting military and civilian health care sectors.

The HJF-MDC Collaboration

This new initiative seeks to grow existing collaborations to accelerate the development and commercialization of dual-use medical technologies for military and civilian applications. As part of this initiative, MDC Studio has established a satellite office within HJF’s innovation facility in Bethesda, Maryland.

Introducing the HJF-MDC Venture Fund

HJF and MDC formed the HJF-MDC Venture Fund, as an independent entity that aims to invest in a diversified portfolio of early-stage companies commercializing military medical technologies with civilian applications. HJF is participating as a non-voting member of the Fund with a minority interest. The Fund’s focus areas include medical devices, wearables for health, and rehabilitation / assistive robotics. The Fund will be overseen by a Board of Managers, who will make investment decisions based on objective selection criteria, including alignment with military medical needs, benefits to civilian health, risks, and expected returns.

Read More

 
Bizjournals: Virginia Tech seeks industry partners for Institute for Advanced Computing

By Nate Doughty – Staff Reporter, Washington Business Journal – Virginia Tech this week unveiled the Institute for Advanced Computing at its Potomac Yard campus to offer academic and research opportunities in AI and quantum computing — and it’s looking for more companies to work with.

At buildout, the institute will employ 50 full-time faculty members and occupy about a third of Virginia Tech’s Academic Building One, a $302 million, 300,000-square-foot facility in Alexandria that opened in January. That’s all somewhat subject to grant funding, enrollment and the total number of partnerships, according to Kirk Cameron, professor of computer science at Virginia Tech and interim director of the institute.

Read More

 

Maryland Matters: Proposed Metro station development tied to growth of life sciences in Montgomery County

State and local leaders touted the promise of a proposed mixed-use development to be built over an existing North Bethesda Metro station as a way to grow Montgomery County’s burgeoning life sciences and tech industries.

The facility is still years away from breaking ground. But Montgomery County Executive Marc Elrich said the effort could transform the area into something similar to Kendall Square in Cambridge, Massachusetts, where technology firms are located close to MIT.

“I had been fascinated by the people I had been talking to about life sciences, and talking to me about Kendall Square in Boston, and talking about the urban campus, and talking about the value of collision spaces … rather than everything being done in office parks, where you never talk to the scientists in the next building,” Elrich said.

Read More

 
Danaher Announces Diagnostic Development and Commercialization Partnership to Scale Precision Medicine

WASHINGTON, May 29, 2025 /PRNewswire/ — Danaher Corporation (NYSE: DHR) (“Danaher”), a global science and technology innovator, announced today the launch of a partnership with AstraZeneca (LSE/STO/Nasdaq: AZN) to develop and commercialize novel diagnostic tools and tests intended to help clinicians better determine which patients would most benefit from precision medicine treatments.

“Precision medicines are more targeted than standard therapies and thus require precision diagnostics to determine which patients are most likely to benefit,” said Julie Sawyer Montgomery, Danaher Executive Vice President. “We are excited to work with AstraZeneca on the goal of creating novel tests to increase access to precision medicines, helping ensure that no patients are left behind.”

Read More

 

FDA Grants RMAT Designation to AbelZeta’s C-CAR168 for Refractory Lupus

ROCKVILLE, Md., May 27, 2025 /PRNewswire/ — AbelZeta Pharma, Inc. (“AbelZeta” or the “Company”), a global clinical-stage biopharmaceutical company focused on discovery and development of innovative and proprietary cell-based therapeutic products, today announced that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to its investigational therapy, C-CAR168, for the treatment of refractory Systemic Lupus Erythematosus (SLE), including Lupus Nephritis (LN).

Read More

 
Baltimore’s Rapafusyn Selected for Roche Accelerator to Tackle Challenging Drug Targets

Baltimore, MD, May 27, 2025 —Rapafusyn Pharmaceuticals Inc., a leader in non-degrading molecular glues, announced today the joining of the Roche Accelerator, Roche’s innovation hub, which connects pioneering biotechs with Roche’s expertise.  Rapafusyn was selected to join the Roche Accelerator, based on Rapafusyn’s innovative RapaGlue™ platform and promising pipeline of potential first-in-class and best-in-class therapeutics.

Read More

 
 

Virginia Business: GO Virginia grant boosts biotech in Roanoke, New River Valley

Ralph Berrier Jr. //June 1, 2025// – A $4.9 million grant from the commonwealth will allow leaders from the  and New River valleys to build upon efforts by  Carilion School of Medicine and the Fralin Biomedical Institute at VTC to turn the region into a hub for .

“As we build the biotech sector, this statewide grant will help us where we have gaps,” explains Erin Burcham, CEO of the Roanoke Blacksburg Innovation Alliance (RBIA), a regional  organization.

The money is a slice of a $14.3 million pie from state economic development initiative  to fund the multiregional Project VITAL (Virginia Innovations and Technology Advancements in Life Sciences), an endeavor to make Virginia a biotechnology leader.

Read More

 
Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

 

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Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

658th Edition, May 28, 2025

By BHI Weekly News Archives

 

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May 28, 2025

HHS layoffs create ‘clear opportunity’ for local health, life sciences companies to add talent — BHI CEO Rich Bendis shares insights with the Washington Business Journal
By Sara Gilgore – Staff Reporter, Washington Business Journal – May 21, 2025 – Once the Department of Health and Human Services unveiled a plan to cut 10,000 positions, United Therapeutics Corp. didn’t waste time.The publicly traded Silver Spring drugmaker saw an opportunity to scoop up some of that talent, hiring a handful of former HHS employees, including from the Food and Drug Administration, and entering into consulting agreements with others, according to Dewey Steadman, UT’s head of investor relations. The 1,305-person company, which counts about 250 D.C.-area employees, has even created a role for one professional with “specific skills that are critical to us,” he said.United Therapeutics (NASDAQ: UTHR) isn’t alone. AstraZeneca, Lonza Group, Kite Pharmaceuticals and Thermo Fisher Scientific are among the local life sciences firms actively hiring, and while no one is cheering the loss of so many public-sector jobs, “there’s a clear opportunity to connect federal talent with private-sector innovation,” said Richard Bendis, president and CEO of Rockville’s BioHealth Innovation Inc.

“These are folks with deep regulatory, scientific, and policy expertise who know how to navigate complex systems and bring big ideas to life,” Bendis said. “And in a region like ours, that’s a serious asset.”

Read More

USM Chancellor Jay Perman: The Reasons for Undergraduate Research
University research has grabbed plenty of headlines over the past few months. Not for the breakthroughs that propel so much of American innovation. Not for the work that advances our health and well-being, that protects our safety, our security, our sustainability. Even so, the discoveries keep coming.No, the new headlines about academic research deal in the grave threats it now faces: massive cuts in the way university R&D is funded, the revocation of grants that don’t align with federal priorities, the slow-walking of new grant approvals.Defending science and scientific inquiry is vital right now, for all the reasons you might imagine—and for one you might not. When academic research is an integrated, meaningful part of the undergraduate experience, it develops students into more critical and creative thinkers, better communicators, collaborators, and problem solvers. Undergraduate research builds learners’ confidence and focuses their career plans. It predicts better grades and graduation rates, and reduces equity gaps, particularly in STEM. Students consistently say that research is among the most valuable components of their college career.

Read More

REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million

ROCKVILLE, Md., May 19, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to $250 million with Healthcare Royalty (HCRx). This agreement monetizes select anticipated royalties and milestones, and provides both immediate and expected future, non-dilutive capital.  REGENXBIO received $150 million at closing, extending the Company’s expected cash runway into early 2027.

Read More

Senseonics Raises $77.8M Through Public Offering and Private Placement
GERMANTOWN, Md., May 21, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the closing of its previously announced underwritten public offering of a total of 115,000,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase up to an additional 15,000,000 shares of common stock, at a public offering price of $0.50 per share.The aggregate gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses were $57.5 million. All of the shares in the offering were sold by Senseonics.

Read More

CEL-SCI Announces Closing of Public Offering
VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the closing of its underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, were $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount.

Read More

ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain
CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.

Read More

Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)
GAITHERSBURG, Md., May 19, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD and alcohol liver disease (ALD). IMPACT, a Phase 2b trial of pemvidutide in MASH, is expected to read out topline data in the second quarter of 2025, and a Phase 2 trial of pemvidutide in ALD is expected to initiate enrollment in the third quarter of 2025.

Read More

 

GeneDx Publishes Pioneering Vision for Applying AI to Genomics to Improve and Expedite Diagnosis of Genetic Disease at Scale
GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the publication of a new article in the American Journal of Medical Genetics, demonstrating GeneDx’s leadership in applying artificial intelligence (AI) to accelerate and enhance genetic diagnostics. The article was published as part of an essay collection written by global experts addressing how AI is shaping, and will continue to shape, the future of medical genetics.The GeneDx-authored article, “AI in the Clinical Genomics Laboratory,” underscores the promise of harnessing AI to increase diagnostic yield, reduce manual workflows, and scale precision medicine for all patients with suspected genetic conditions.

Read More

Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study
ASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin’s lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin’s ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances.

Read More

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025
Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 

658th Edition, May 28, 2025

By BHI Weekly News Archives

HHS layoffs create ‘clear opportunity’ for local health, life sciences companies to add talent — BHI CEO Rich Bendis shares insights with the Washington Business Journal

By Sara Gilgore – Staff Reporter, Washington Business Journal – May 21, 2025 – Once the Department of Health and Human Services unveiled a plan to cut 10,000 positions, United Therapeutics Corp. didn’t waste time.

The publicly traded Silver Spring drugmaker saw an opportunity to scoop up some of that talent, hiring a handful of former HHS employees, including from the Food and Drug Administration, and entering into consulting agreements with others, according to Dewey Steadman, UT’s head of investor relations. The 1,305-person company, which counts about 250 D.C.-area employees, has even created a role for one professional with “specific skills that are critical to us,” he said.

United Therapeutics (NASDAQ: UTHR) isn’t alone. AstraZeneca, Lonza Group, Kite Pharmaceuticals and Thermo Fisher Scientific are among the local life sciences firms actively hiring, and while no one is cheering the loss of so many public-sector jobs, “there’s a clear opportunity to connect federal talent with private-sector innovation,” said Richard Bendis, president and CEO of Rockville’s BioHealth Innovation Inc.

“These are folks with deep regulatory, scientific, and policy expertise who know how to navigate complex systems and bring big ideas to life,” Bendis said. “And in a region like ours, that’s a serious asset.”

Read More

 
USM Chancellor Jay Perman: The Reasons for Undergraduate Research

University research has grabbed plenty of headlines over the past few months. Not for the breakthroughs that propel so much of American innovation. Not for the work that advances our health and well-being, that protects our safety, our security, our sustainability. Even so, the discoveries keep coming.

No, the new headlines about academic research deal in the grave threats it now faces: massive cuts in the way university R&D is funded, the revocation of grants that don’t align with federal priorities, the slow-walking of new grant approvals.

Defending science and scientific inquiry is vital right now, for all the reasons you might imagine—and for one you might not. When academic research is an integrated, meaningful part of the undergraduate experience, it develops students into more critical and creative thinkers, better communicators, collaborators, and problem solvers. Undergraduate research builds learners’ confidence and focuses their career plans. It predicts better grades and graduation rates, and reduces equity gaps, particularly in STEM. Students consistently say that research is among the most valuable components of their college career.

Read More

 

REGENXBIO Announces Strategic Royalty Monetization Agreement for Up to $250 Million

ROCKVILLE, Md., May 19, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the closure of a non-dilutive, limited recourse royalty bond agreement of up to $250 million with Healthcare Royalty (HCRx). This agreement monetizes select anticipated royalties and milestones, and provides both immediate and expected future, non-dilutive capital.  REGENXBIO received $150 million at closing, extending the Company’s expected cash runway into early 2027.

Read More

 
Senseonics Raises $77.8M Through Public Offering and Private Placement

GERMANTOWN, Md., May 21, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced the closing of its previously announced underwritten public offering of a total of 115,000,000 shares of its common stock, which included the exercise in full by the underwriters of their option to purchase up to an additional 15,000,000 shares of common stock, at a public offering price of $0.50 per share.

The aggregate gross proceeds from the public offering, before deducting underwriting discounts and commissions and offering expenses were $57.5 million. All of the shares in the offering were sold by Senseonics.

Read More

 

CEL-SCI Announces Closing of Public Offering

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (“CEL-SCI” or the “Company”) (NYSE American: CVM), a clinical stage cancer immunotherapy company, today announced the closing of its underwritten public offering of 2,000,000 shares of its common stock at a public offering price of $2.50 per share. Total gross proceeds from the offering, before deducting the underwriting discount and other offering expenses, were $5,000,000. In addition, the Company has granted the underwriters a 45-day option to purchase up to an additional 190,000 shares to cover over-allotments at the public offering price, less the underwriting discount.

Read More

 
ReGelTec Receives CE Mark for HYDRAFIL® System to Treat Chronic Low Back Pain

CE Mark approval for the HYDRAFIL System was granted based on a clinical study of 75 patients that showed that those treated with HYDRAFIL experienced clinically and statistically significant improvements in pain and disability. Results demonstrated a more than 80% improvement in Oswestry Disability Index (ODI) scores and greater than 70% reduction in Numeric Pain Rating Scale scores after HYDRAFIL treatment, with reductions sustained for two years in the 63 patients that have completed their two-year follow-up visit.

Read More

 

Webinar: Turning Uncertainty to Opportunity: Mastering Government Funding in 2025

Navigating the Shifting Federal Funding Landscape

Strategies, Insights, and AI-Driven Approaches for Winning Non-Dilutive Capital

The federal funding landscape is undergoing a significant transformation. With a new administration in office, the dynamics of securing non-dilutive capital are shifting—requiring organizations to move strategically and with precision to stay ahead. In this high-impact 45-minute session, Grant Engine and BioHealth Innovation bring together their leadership to break down the latest changes, clarify what remains uncertain, and showcase what top-performing companies are doing right now to secure meaningful, large-scale funding.

Read More

 
Altimmune Announces Initiation of RECLAIM Phase 2 Trial Evaluating the Efficacy and Safety of Pemvidutide in Alcohol Use Disorder (AUD)

GAITHERSBURG, Md., May 19, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has enrolled the first subject in the RECLAIM Phase 2 trial evaluating the efficacy and safety of pemvidutide in subjects with Alcohol Use Disorder (AUD). Pemvidutide is a novel, investigational GLP-1/glucagon dual receptor agonist under development for the treatment of metabolic dysfunction-associated steatohepatitis (MASH), obesity, AUD and alcohol liver disease (ALD). IMPACT, a Phase 2b trial of pemvidutide in MASH, is expected to read out topline data in the second quarter of 2025, and a Phase 2 trial of pemvidutide in ALD is expected to initiate enrollment in the third quarter of 2025.

Read More

 
 

GeneDx Publishes Pioneering Vision for Applying AI to Genomics to Improve and Expedite Diagnosis of Genetic Disease at Scale

GAITHERSBURG, Md.–(BUSINESS WIRE)–GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the publication of a new article in the American Journal of Medical Genetics, demonstrating GeneDx’s leadership in applying artificial intelligence (AI) to accelerate and enhance genetic diagnostics. The article was published as part of an essay collection written by global experts addressing how AI is shaping, and will continue to shape, the future of medical genetics.

The GeneDx-authored article, “AI in the Clinical Genomics Laboratory,” underscores the promise of harnessing AI to increase diagnostic yield, reduce manual workflows, and scale precision medicine for all patients with suspected genetic conditions.

Read More

 
Quoin Pharmaceuticals Announces FDA Clearance to Initiate Second Pivotal Whole Body QRX003 Netherton Syndrome Clinical Study

ASHBURN, Va., May 22, 2025 (GLOBE NEWSWIRE) — Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces FDA clearance to initiate a second Netherton Syndrome (NS) pivotal clinical study CL-QRX003-002 for QRX003. Quoin’s lead product, QRX003, is a topical lotion formulated with a broad-spectrum serine protease inhibitor that has been shown to significantly downregulate the hyperactivity of the kallikreins in the skin responsible for the excessive skin shedding associated with this disease. Clinical data from Quoin’s ongoing studies has demonstrated clear evidence of rapid, prolonged and almost complete skin healing following twice-daily application of QRX003 to the treatment areas along with the almost complete elimination of key symptoms such as chronic, debilitating pruritus and has facilitated zero nightly sleep disturbances.

Read More

 

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

657th Edition, May 20, 2025

By BHI Weekly News Archives

Maryland Stem Cell Research Fund Awards Over $18 Million to Drive Breakthroughs in Regenerative Medicine

Awardees receive funding to accelerate research and development of stem cell therapies

COLUMBIA, Md., (May 13, 2025) — The Maryland Stem Cell Research Commission (“Commission”) announced awarding over $18 million in grants aimed at accelerating cutting-edge stem cell and regenerative medicine research across Maryland.

This funding supports 52 investigators from top Maryland based research institutions and companies working on almost 50 different medical conditions and diseases including sickle cell anemia, diabetes, cancers and chronic pain to diseases directed to heart, bone, blood, digestive and neurological conditions. This year’s grant recipients feature innovative companies such as Seraxis Inc., Britecyte Inc., SereNeuro Therapeutics Inc. and Diagnostic Biochips, Inc. They are joined by academic researchers from Johns Hopkins University, University of Maryland, Baltimore, University of Maryland, College Park, University of Maryland, Baltimore County and the Uniformed Services University of Health Sciences/Henry Jackson Foundation. The University of Maryland, Eastern Shore is newly represented among this year’s funded institutions, strengthening statewide support for regenerative medicine research.

Read More

 
Remedy Plan Therapeutics Raises $18 Million Financing to Accelerate Advancement of Lead Asset RPT1G into Phase 1/2 Trials

GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Remedy Plan Therapeutics (Remedy Plan), a privately-held, clinical-stage pharmaceutical company developing novel, hyperbolic NAMPT inhibitors, today announced the company has raised over $18 million in an oversubscribed insider financing round. The round includes participation from Schooner Capital and Alexandria Venture Investments. This brings the company’s total funding to date to $55 million.

The financing will accelerate the advancement of the company’s first-in-class NAMPT inhibitor, RPT1G, into a Phase 1/2 clinical study in patients with AML or high-risk MDS. This builds on the momentum of an ongoing first-in-human study in healthy adults (NCT06667765), which will conclude later this month. The investment will also support the continued development of Remedy Plan’s pipeline of NAMPT inhibitors with applications across solid tumors, autoimmune diseases, and obesity.

Read More

 

Altimmune Secures Up to $100 Million in Credit Facility from Hercules Capital

GAITHERSBURG, Md., May 13, 2025 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a late clinical-stage biopharmaceutical company developing novel peptide-based therapeutics for liver and cardiometabolic diseases, today announced that it has entered into an agreement with Hercules Capital, Inc. (NYSE: HTGC), a leader in debt financing for life science companies, for up to $100 million in a credit facility, with a $15 million tranche funded at closing. Additional tranches will become available upon achievement of certain clinical and financial milestones aligned with the Company’s pemvidutide development plans and financing needs.

Read More

 

FDA Accepts REGENXBIO’s Application for Priority Review of Gene Therapy for Hunter Syndrome (MPS II)

ROCKVILLE, Md., May 13, 2025 /PRNewswire/ — REGENXBIO Inc. (Nasdaq: RGNX) today announced the U.S. Food and Drug Administration (FDA) has accepted for review the Biologics License Application (BLA) seeking accelerated approval for clemidsogene lanparvovec (RGX-121) for the treatment of Mucopolysaccharidosis II (MPS II), also known as Hunter syndrome.

The FDA granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of November 9, 2025.

Read More

 
 

VPM: Mark Esser wants to make Charlottesville the Silicon Valley of biotech

By Phil Liles: The University of Virginia has named Mark Esser as the first chief scientific officer of the upcoming Paul and Diane Manning Institute of Biotechnology.

Esser will work with scientists to accelerate the development of new medicines and treatments for illnesses like cancer and Alzheimer’s.

Morning Edition Host Phil Liles spoke with Esser about his desire to turn a corner on incurable diseases, which he noted, requires significant federal funding. That funding is now uncertain as President Donald Trump halts $1.8 billion dollars in grants from the National Institutes of Health.

Read More

 
Senseonics Announces Commencement of $50 Million Public Offering of Common Stock and Concurrent Private Placement

GERMANTOWN, Md., May 15, 2025 (GLOBE NEWSWIRE) — Senseonics Holdings, Inc. (NYSE American: SENS), a medical technology company focused on the development and manufacturing of long-term, implantable continuous glucose monitoring (CGM) systems for people with diabetes, today announced that it has commenced an underwritten public offering, subject to market and other conditions, to issue and sell shares of its common stock. In connection with the proposed offering, Senseonics also expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the total number of shares of common stock offered in the public offering. All of the shares of common stock to be sold in the proposed offering will be offered by Senseonics.

Read More

 

Save the Date & Sponsor the Future: BioHealth Capital Region Week Returns September 23–25, 2025

Mark your calendars! The 11th Annual BioHealth Capital Region Forum will return September 23rd–24th, 2025, once again hosted at US Pharmacopeia (USP) in Rockville, Maryland. This year’s theme, “The BioHealth Capital Region: Where Human and Artificial Intelligence Converge in the BioHealth Industry,” sets the tone for a timely and necessary conversation. As our sector faces new challenges and opportunities, 2025 is a critical year to align on strategy, innovation, and regional collaboration.

In addition to the Forum, we are excited to bring back the 8th Annual BioHealth Capital Region Investment Conference on September 25th, also at USP. Designed to foster meaningful connections between startups and investors, this conference continues to be a key driver of funding and momentum across our ecosystem.

A Call for Sponsors

We invite returning and new sponsors to help make this year’s event possible. Your support not only fuels the success of the Forum and Investment Conference but also ensures these events remain free to attend for all participants across the region. With your help, we’ll once again bring together over 1,000 leaders from government, industry, and academia to chart the course for the future of biohealth.

Read More

 

Home | About BHI | BHI News | Programs | Partners | Contact

Copyright  BioHealth Innovation 2025
All Rights Reserved.

 
 

 

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