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:
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Spotify - https://spoti.fi/4km1v8L
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Ralph Berrier Jr. //June 1, 2025// - A $4.9 million grant from the commonwealth will allow leaders from the Roanoke and New River valleys to build upon efforts by Virginia Tech Carilion School of Medicine and the Fralin Biomedical Institute at VTC to turn the region into a hub for biomedical research.

“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 economic development organization.

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

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.

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.

Baltimore, Md. (May 28, 2025) – CoapTech Inc., a Baltimore-based medical device company, announced today the initial close of a Series B funding round, which was led by Good Growth Capital, an early-stage venture capital firm that invests in transformative science and technology, with participation from the University System of Maryland (USM) Momentum Fund (Momentum Fund) and the University of Maryland, Baltimore (UMB), a previous investor.  Additional funds joining the round included NuFund, TEDCO, The Abell Foundation, and Ecphora Capital.  

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.

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.

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).

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.

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.

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.

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.

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.

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.

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.”

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.

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.

ASHBURN, Va., May 20, 2025 (GLOBE NEWSWIRE) -- Quoin Pharmaceuticals Ltd. (NASDAQ: QNRX) (the “Company” or “Quoin”), a late clinical stage, specialty pharmaceutical company focused on rare and orphan diseases, today announces that it has been granted Orphan Drug Designation in Europe by the European Medicines Agency (EMA) for its lead product QRX003 in Netherton Syndrome.

Orphan Drug Designation in Europe affords the Company incentive benefits including scientific advice on study protocols, various fee reductions and access to EU grants. If approved, QRX003 will be granted 10 years of market exclusivity in Europe for the treatment of Netherton Syndrome.

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.

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.

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.

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.

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.

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.

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.

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.

In this episode of BioTalk, host Rich Bendis welcomes Sona Shah, CEO and Co-Founder of Neopenda, for an inspiring conversation on innovation, impact, and scaling medical technology in underserved markets. Sona shares how a formative experience teaching in rural Kenya ignited her passion for global health, leading to the creation of neoGuard, a wearable vital signs monitor tailored for low-resource settings. This episode builds on a recent article featured on the BHI News page, offering a deeper look into Neopenda’s journey, innovations, and impact in global health.

They discuss the engineering challenges of building clinical-grade hardware for hospitals with limited infrastructure, the company’s growth from Maryland’s Relevant Health accelerator, and the deployment of over 350 devices across East and West Africa. Sona also talks about Neopenda’s next wave of products, lessons in balancing cost and quality, and the importance of community, resilience, and mission-driven entrepreneurship.

Listen now on your favorite podcast platforms:
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The NCI Technology Transfer Center has an upcoming NIH Technology Opportunity Webinar
May 28, 2025 | 11:00 AM ET
Radiolabeled Sugars for Imaging of Fungal Infections
Hosted by Joseph Conrad | Featuring Dr. Dima A. Hammoud

Join this free webinar to learn about a novel PET radiotracer, [18F]-fluorocellobiose ([18F]-FCB), developed by NIH researchers. Unlike standard FDG, this agent targets fungal-specific metabolism, enabling early, non-invasive detection and real-time monitoring.

This technology addresses a critical need in diagnosing fungal infections in immunocompromised patients.

https://bit.ly/3Srhfe9

GAITHERSBURG, Md. & OAKLAND, Calif.--(BUSINESS WIRE)--GeneDx (Nasdaq: WGS), a leader in delivering improved health outcomes through genomic insights, today announced the successful completion of its acquisition of Fabric Genomics, a pioneer in AI-powered genomic interpretation. Together, GeneDx and Fabric Genomics are ushering in the next era of genomic medicine, enabling decentralized testing powered by centralized intelligence to set the standard of care across the globe.

“Healthcare is at an inflection point where genomic insights must be integrated into standard care to improve outcomes and reduce costs,” said Katherine Stueland, President and CEO of GeneDx. “With Fabric Genomics now part of GeneDx, we’re uniquely positioned to deliver earlier and more accurate diagnoses worldwide, from NICUs and pioneering newborn screening programs to health systems across the globe.”

ROCKVILLE, Md., May 07, 2025 (GLOBE NEWSWIRE) -- Theriva Biologics (NYSE American: TOVX), (“Theriva” or the “Company”), a diversified clinical-stage company developing therapeutics designed to treat cancer and related diseases in areas of high unmet need, today announced the pricing of its “reasonable best efforts” public offering for the purchase and sale of up to 6,818,180 shares of common stock (or pre-funded warrants in lieu thereof) and warrants to purchase up to 6,818,180 shares of common stock at a combined offering price of $1.10 per share and accompanying warrant (the “Offering”). The Company expects to receive aggregate gross proceeds of approximately $7.5 million, before deducting placement agent fees and other offering expenses, and assuming no exercise of the warrants. The warrants will have an exercise price of $1.10 per share, will be exercisable immediately and will expire five years from the issuance date.

COLUMBIA, Md., (May 7, 2025) — TEDCO, Maryland’s economic engine for technology companies, announced the appointment of its chief development and marketing officer, Tammi Thomas, as the elected president of the Maryland Economic Development Association’s (MEDA) Board of Directors. She began her two-year term on April 28, 2025, during the MEDA Annual Conference.

Thomas’ leadership comes as the organization reaches a record high of 576 members, marking a new chapter for MEDA as it continues to promote inclusive economic growth throughout Maryland. In addition to record breaking membership numbers, the organization finished the conference by raising more than $12,000 during the annual silent auction for the Rhonda Ray Scholarship and the Lofton Scholarship Fund. These two unique scholarship opportunities offer support to individuals in economic development or public policy courses.

By Sara Gilgore – Staff Reporter, Washington Business Journal - May 6, 2025 - 

AstraZeneca PLC (NYSE: AZN) has opened a new Rockville manufacturing hub, a whopping $300 million investment for the British pharmaceutical giant — and a big win for Montgomery County in a tough moment for the sector locally.

The company, which held a ribbon-cutting event Monday, intends to use its 85,000-square-foot Rockville Manufacturing Center at 9950 Medical Center Drive to initially make T-cell therapies for clinical trials in cancer. It had unveiled its plans for the project last February and is now getting ready to move people in.

“Rockville represents the future of manufacturing,” an AstraZeneca spokesperson told me over email, noting the space was built out using 3D-modeling, virtual reality and artificial intelligence, which helped speed up operational and construction timelines.

KENSINGTON, Md. and MUNICH and MARTINSRIED, Germany, May 06, 2025 (GLOBE NEWSWIRE) -- Galimedix Therapeutics, Inc. (“Galimedix”), a Phase 2 clinical-stage biotechnology company developing novel oral and topical neuroprotective therapies with the potential to revolutionize the treatment of serious brain and eye diseases, today announced the completion of the single ascending dose (SAD) part of the Phase 1 study with orally administered GAL-101, a small molecule specifically designed to target misfolded amyloid beta (Aβ) monomers.