News

Validation Completed for a Novel, Cost-Competitive Epinephrine Active Pharmaceutical Ingredient Process, Drug Master File Successfully Filed

Richmond, Virginia, March 17, 2025 (GLOBE NEWSWIRE) — Phlow Corp., a U.S.-based certified B Corporation on a mission to bring medicines to life through advanced development and manufacturing in America, today announced a major milestone, achieving a successful process validation campaign for Epinephrine active pharmaceutical ingredient (API) production. This achievement positions Phlow to continue advancing toward full domestic production capabilities in its state-of-the-art U.S. facilities for this life-saving medicine.

The National Institutes of Health (NIH) is vital in driving scientific discovery and economic growth across the United States. Recent reports from United for Medical Research (UMR) and Forbes highlight just how impactful NIH funding has been—generating $94.58 billion in economic activity in FY2024 alone and supporting more than 407,000 jobs nationwide. For every $1 invested, NIH research funding returns $2.56 in economic impact.

For the BioHealth Capital Region (BHCR)—home to NIH, the FDA, and a growing network of research institutions and life sciences companies—this funding is critical. NIH grants fuel the work of startups, researchers, and small businesses developing groundbreaking technologies in biotech, AI-driven drug discovery, personalized medicine, and advanced therapeutics. Without sustained investment, the entire innovation ecosystem is at risk, impacting job creation, commercialization efforts, and, ultimately, patient outcomes.

HONOLULU, HI, Mar. 12, 2025 – Motivity, a leading provider of clinical SaaS solutions for Applied Behavior Analysis (ABA) providers who treat children with autism, today announced a $27 million investment from Five Elms Capital, a leading software investment firm. The funding will enable Motivity to accelerate product innovation, expand its team, and strengthen support for ABA providers worldwide.

Since its founding in 2012, Motivity’s mission has been to empower ABA clinicians with cutting-edge technology that strengthens clinical effectiveness and improves outcomes. To date, the company has secured $11 million in Small Business Innovative Research (SBIR) grants used to develop next-generation solutions, including AI-driven workflows, analytics for clinical decision support, and caregiver engagement tools. Today, Motivity serves over 550 organizations across seven countries, enhancing the delivery of high-quality, data-driven care.

By Sara Gilgore – Staff Reporter, Washington Business Journal -Mar 12, 2025 – Gaithersburg’s Shuttle Pharmaceuticals Holdings Inc. (NASDAQ: SHPH) has brought in a new executive to spearhead the biotech’s business activity, freeing up its longtime leader, a cancer doctor and physician administrator, to focus on research and development.

The company’s co-founder and chief executive, Dr. Anatoly Dritschilo, is now one of two co-CEOs, and will oversee the clinical trials and scientific work required to get its lead candidate for an aggressive brain cancer to patients. And Christopher Cooper, a former oil and gas industry exec who also leads a telecommunications company, has joined Shuttle as the other co-CEO on an interim basis. He will focus on the business activity and raising money through the capital markets, the firm said Wednesday.

VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today announced it received comments from the U.S. Food and Drug Administration (FDA) on the confirmatory Registration Study’s Statistical Analysis Plan (SAP) submitted in December of 2024 for the study of Multikine* (Leukocyte Interleukin, Injection) as a neoadjuvant in the treatment of newly diagnosed previously untreated locally advanced head and neck cancer. The FDA stated no response to their comments were required from CEL-SCI and that the agency presently has no comments on the confirmatory study protocol, which was submitted for FDA review contemporaneously with the SAP in December 2024.

CEL-SCI’s 73,000 square foot Multikine manufacturing facility presently has the capacity to produce over 12,000 Multikine treatments per year. Over $200 million has been invested in the facility and the development and validation of its proprietary biologic manufacturing processes.

BETHESDA, Md., March 14, 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 announced the dosing of the first participant with Parkinson’s disease (PD) in its Phase 1b clinical trial of GT-02287, the Company’s lead allosteric small molecule in development for the treatment of PD with or without a GBA1 mutation.

“Initiation of dosing in our Phase 1b clinical trial represents an important step in the clinical development of GT-02287 and in Gain’s mission to deliver a disease-modifying therapy to people with Parkinson’s disease. We look forward to continued enrollment and anticipate an interim analysis from the towards the end of 2Q 2025,” said Gene Mack, President and CEO of Gain Therapeutics.

GAITHERSBURG, Md. and BASEL, Switzerland, March 12, 2025 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS), a leading public health company that delivers protective and life-saving solutions to communities across the world, and Rocketvax Ltd, one of Switzerland’s next-generation vaccine companies and a member of the Swiss Rockets Ltd family of companies, today announced entry into an agreement for Emergent’s strategic financial investment into Swiss Rockets Ltd, the parent company of Rocketvax Ltd, to support research, infrastructure development, and the expansion of Swiss Rockets’ innovative biotechnology portfolio. This endeavor underscores Emergent’s commitment to supporting Swiss Rockets’ broader mission of pioneering breakthrough medical technologies.

Rockville, Md. (March 11, 2025) – Cellphire Therapeutics, Inc., a clinical stage biotechnology company developing next-generation allogeneic, platelet-derived, cellular therapeutics, is excited to announce that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for CLPH-511 (Frozen Activated Platelets) Injectable Suspension for the treatment of acute hemorrhage as an alternative to conventional platelets when not available or in short supply.  

COLLEGE PARK, Md.–(BUSINESS WIRE)– IonQ, Inc. (NYSE: IONQ), a leader in the quantum computing and quantum networking industries, today announced that under its “at-the-market” equity offering program (the “ATM Program”) it has sold a total of 16,038,460 shares of its common stock for an aggregate amount of approximately $372.6 million, netting aggregate proceeds of approximately $360 million.

The Company has determined that it has raised a sufficient amount under the program to meet its currently anticipated capital needs. The Company also determined that given overall recent market disruptions, the trading prices for its shares, and the overhang from having an ATM Program in effect, the ATM Program should be terminated. The Company has therefore terminated the ATM Program today and a prospectus supplement will be filed under Rule 424(c) reflecting such termination.