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.

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).

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.

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.

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.

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.”

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.

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.

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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.

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.

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.

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."

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.”

WASHINGTON, June 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).

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.

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.

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.

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

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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.

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.

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.”

COLUMBIA, Md., June 4, 2025 — Welldoc^®, a leader in AI-powered digital health innovation, today announced it will power the newly launched Lilly Health™ Personalized Health & Medicine Platform* (Lilly Health app) with its cardiometabolic digital health platform. The Lilly Health app is designed to support a tailored patient experience for individuals interested in or using Eli Lilly and Company’s incretin-based therapies, for the treatment of cardiometabolic conditions, such as obesity, type 2 diabetes, and moderate- to-severe obstructive sleep apnea and obesity. Initially, the Lilly Health app will be available for patients prescribed Zepbound® (tirzepatide)** or Mounjaro® (tirzepatide)**.

Lilly and Welldoc aim to build a more seamless patient experience through educational resources and targeted support. The Lilly Health app will provide features to help patients with their cardiometabolic health goals and weight, such as medication logging, reminders, device connectivity and health data tracking.

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.

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. 

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.

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.

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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.