June 30, 2026

SAN DIEGO — Biotechnology is entering one of the most transformative periods in its history. But, according to Biotechnology Innovation Organization (BIO) CEO John Crowley, outdated regulations, rising development costs, and global competition threaten to slow progress unless policymakers act.

At the 2026 BIO International Convention in San Diego this week—which drew “roughly 20,000 attendees,” according to the organizers—Crowley outlined a vision for the future of biotechnology centered on accelerating clinical research, embracing artificial intelligence, and maintaining U.S. leadership in a rapidly evolving global bioeconomy.

The grassroots gauntlet

Crowley’s personal journey as a father shaped his path into biotechnology. In the late 1990s, two of his children were diagnosed with a rare form of muscular dystrophy. He left Bristol-Myers Squibb’s marketing department to co-found a biotechnology company with an Oklahoma academic researcher over scientific progress.

The struggle to get funding was immense. Crowley reflected on his first BIO convention in 2000 amidst the excitement of the Human Genome Project: “I came and there were tens of thousands of people partnering as there is today, still a quarter of a century later. Being the 31-year-old CEO of a small startup in Oklahoma City with no money, literally nobody signed up to meet with me and nobody accepted my meeting request.”

Applications are now being accepted for the BioHealth Capital Region Crab Trap Competition, returning as part of the 12th Annual BioHealth Capital Region Week, taking place September 15, 16, and 17, 2026, at US Pharmacopeia in Rockville, Maryland. Apply today at https://bit.ly/CrabTrap2026.

The Crab Trap Competition highlights promising early-stage biohealth companies developing new technologies, products, and solutions across therapeutics, diagnostics, medical devices, digital health, research tools, and other areas of life sciences innovation. Each year, the competition gives selected entrepreneurs the opportunity to present their companies in front of experienced investors, industry leaders, subject matter experts, and regional ecosystem partners.

Five finalists will be selected to pitch live during BioHealth Capital Region Week. Each finalist will deliver a seven-minute company presentation, followed by a three-minute question-and-answer session with the judges. The format gives entrepreneurs a focused opportunity to explain the problem they are solving, the strength of their technology, market opportunity, commercialization strategy, management team, funding progress, and key milestones.

SILVER SPRING, Md. & RESEARCH TRIANGLE PARK, N.C.--(BUSINESS WIRE)--United Therapeutics Corporation (Nasdaq: UTHR), a public benefit corporation, today announced that the U.S. Food and Drug Administration (FDA) has granted premarket approval (PMA) of the LungFXTM device (LungFX) for use in centralized ex vivo lung perfusion (EVLP), a procedure that enables donor lungs to be assessed outside the body after procurement and before transplantation.

The PMA, submitted by United Therapeutics’ wholly owned subsidiary, Lung Bioengineering Inc., included comprehensive safety and effectiveness data supporting use of LungFX to perform EVLP in a centralized facility.

LungFX is indicated for centralized, ex vivo (outside the body) evaluation of deceased-donor lungs (single and double) that cannot be placed for transplantation by an organ procurement organization (OPO) with any of the matched candidates if using direct-to-recipient procurement and preservation procedures. LungFX provides normothermic perfusion and ventilation of procured donor lungs initially stored with cold static preservation solution.

GAITHERSBURG, Md., June 29, 2026 (GLOBE NEWSWIRE) -- Emergent BioSolutions (NYSE:EBS) today announced it has been awarded a contract modification valued at $52.7 million from the Administration for Strategic Preparedness and Response (ASPR) at the United States Department of Health and Human Services to supply ACAM2000® (Smallpox and Mpox (Vaccinia) Vaccine, Live) vaccine, ancillaries as well as diluent replacement lots for smallpox preparedness and response needs. Deliveries are expected to begin this month.

“This new contract modification for ACAM2000® underscores the U.S. government’s continued focus on biodefense preparedness and reflects Emergent’s longstanding role to collaborate and help protect civilians and warfighters against potential smallpox and mpox threats,” said Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent. “In this increasingly dangerous world, we are proud to continue supporting the U.S. government as they continue to take critical, proactive steps on biodefense preparedness.”

This award follows Emergent’s recent announcements that the Saudi Food and Drug Authority has approved ACAM2000® for immunization against smallpox and mpox in high-risk individuals and that Singapore’s Health Sciences Authority has approved an expanded indication for ACAM2000® to include prevention of mpox disease in adults determined to be at high risk for mpox infection.

BioHorizons: Partnering to Secure the Future of Biotechnology is an invitation-only forum taking place on August 11, 2026, from 9:00 AM to 4:00 PM at the Johns Hopkins Applied Physics Laboratory in Fulton, Maryland. The event is hosted by APL and is designed to bring together senior leaders across the biotech and national security sectors for a full day of immersive engagement.

The forum is grounded in priority areas aligned with the National Security Commission on Emerging Biotechnology, with a focus on two key themes: Biomanufacturing and Response Technologies, and Advanced Sensing for Detection and Triage. Attendees will have the opportunity to experience live technology demonstrations from APL experts, gain insights into national security-driven biotech priorities, and explore joint initiatives aimed at mobilizing public and private resources.

BioHorizons is built for relationship-building and strategic alignment, connecting innovators, scientists, engineers, and decision-makers from across the biotech ecosystem. The event offers a unique opportunity to shape investment and innovation strategies in alignment with national security goals. Registration closes July 31, 2026, and interested participants can register through the Johns Hopkins APL event portal.

ROCKVILLE, Md., June 29, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the first patient has been dosed in the Phase IIb/III NAAVIGATE clinical trial of investigational surabgene lomparvovec (sura-vec, ABBV-RGX-314) in diabetic retinopathy (DR) using suprachoroidal delivery. REGENXBIO will receive $100 million from AbbVie for this milestone.

"Dosing the first patient in the Phase IIb/III study is a significant milestone in our commitment with AbbVie to bring a one-time gene therapy to patients who continue to face progressive and vision-threatening complications across multiple chronic retinal diseases," said Steve Pakola, M.D., Chief Medical Officer, REGENXBIO. "We are excited to advance sura-vec for DR, following the two-year data that reinforced the durable and disease-modifying impact that sura-vec has the potential to deliver with a single administration. The opportunity to prevent disease progression before vision damage occurs is critical for this population, and we are collaborating closely with the investigators and AbbVie to progress this innovative treatment option."

BALTIMORE, June 26, 2026 (GLOBE NEWSWIRE) -- Elixirgen Therapeutics, Inc., a clinical-stage biotechnology company developing treatments for rare diseases and aging-associated diseases, today announced that it has entered into an option agreement with Nippon Shinyaku Co., Ltd. (Headquarters, Kyoto, Japan; President, Toru Nakai). Under the terms of the agreement, Elixirgen will be responsible for the development of EXG-7001 for the treatment of Duchenne Muscular Dystrophy (DMD) and Nippon Shinyaku may obtain exclusive worldwide rights to commercialize EXG-7001. Nippon Shinyaku will provide the funding for the developmental costs, and Elixirgen will receive an upfront payment and is eligible to receive additional development and sales-based milestone payments if the option were to be exercised. Following the exercise of the option rights by Nippon Shinyaku and regulatory approval in the United States, NS Pharma, Inc. (New Jersey, USA, President: Yukiteru Sugiyama), a wholly owned subsidiary of Nippon Shinyaku, will market and commercialize EXG-7001.

“Current approaches for treating DMD focus on delivering or restoring an incomplete dystrophin protein, and there still remains a significant unmet need for a therapy that can successfully deliver a full-length dystrophin protein,” said Aki Ko, Chief Executive Officer of Elixirgen Therapeutics. “By design, EXG-7001 has the potential to deliver the full-length, complete dystrophin protein that is missing in DMD patients, regardless of their genetic mutation. We look forward to combining Elixirgen’s clinical and regulatory excellence with Nippon Shinyaku’s expertise and mission to improve the lives of those living with rare diseases.”

ROCKVILLE, Md., June 24, 2026 /PRNewswire/ -- REGENXBIO Inc. (Nasdaq: RGNX) today announced the successful completion of dosing in the confirmatory study of RGX-202, a potential best-in-class gene therapy for Duchenne muscular dystrophy. This milestone positions REGENXBIO to initiate a Biologics License Application (BLA) under the accelerated approval pathway in Q3 2026 for a potential approval by the U.S. Food and Drug Administration (FDA) in the second half of 2027.

The BLA submission will include a substantial safety dataset from the AFFINITY DUCHENNE® study of RGX-202 pivotal and confirmatory studies (n=63) and efficacy data from the pivotal portion (n=30). The BLA is expected to include 12-month functional data for at least half of the total participants in the pivotal study.

"Completing the enrollment of our confirmatory study ahead of schedule is a significant milestone that underscores the urgent unmet need in Duchenne and brings us another step closer to advancing RGX-202 towards approval via the accelerated approval pathway," said Curran Simpson, President and Chief Executive Officer of REGENXBIO. "We are encouraged by the recent FDA trends in rare disease development, including our collaborative discussion with FDA regarding our Hunter Syndrome program, demonstrating that...

CvilleBioHub is now accepting applications for BioSpark, a competitive live pitch event for early-stage life sciences startups taking place during the 2026 BioDiscovery Summit on September 17 in Charlottesville, Virginia.

Eight companies will be selected to pitch before a panel of judges and an audience of life sciences investors, industry leaders, and summit attendees. Eligible companies should be U.S.-based, pre-seed or seed-stage, have a formal entity, own the rights to their technology, and have raised no more than $10 million to date.

BioSpark is open to companies working across therapeutics, digital health and analytics, medical devices, diagnostics, healthcare delivery, AI healthcare services, and related healthcare technologies. This year’s prize pool includes $20,000 for first place, $10,000 for second place, and a year of access to CvilleBioHub’s Commonwealth BioAccelerator for third place.

Applications close August 15, 2026.

Learn more and apply through CvilleBioHub.

Stemora Inc., a Maryland-based biotechnology company developing next-generation regenerative therapies for osteoarthritis and cartilage injuries, today announced that it has been awarded a $305,000 National Science Foundation (NSF) Small Business Innovation Research (SBIR) Phase I grant.

The award supports Stemora's development of a one-step, intraoperative regenerative therapy designed to restore durable hyaline cartilage by activating the body's own skeletal stem cells (SSCs). The company's platform uses a modular, controlled-release biomaterial system engineered to create a pro-regenerative environment within cartilage defects. This approach offers an innovative advancement to currently available treatment methods limited to long-term pain management, complex cell-based interventions, or partial/total joint replacement.

The NSF award will enable Stemora to advance its biomaterial delivery system and evaluate its regenerative potential in translational preclinical models, positioning the company for future development milestones and follow-on funding opportunities.