FDA Backs GV104 Prophylaxis Path After Simulation Prevents All Fentanyl Cardiac Arrests
HEPA has more than doubled off its 52-week low of $0.034.
Summary
Hepion said the FDA gave written feedback on its July 2026 modeling package for GV104, the nalmefene buccal film acquired with Gravitas Life Sciences, re-affirming the overall approach and suggesting changes to model structure, results presentation and the fentanyl challenge simulations. The company believes every comment is addressable within its existing modeling program and plans to respond promptly. In the submitted analysis, a single 16 mg film taken at least 15 minutes before exposure prevented every simulated fentanyl-induced cardiac arrest across 200 virtual subjects, while 86.5% of untreated subjects at the highest dose modeled were expected to arrest; predicted protection onset improved to a median of 10-15 minutes from roughly 30 minutes estimated in 2025. This follows the October 19 disclosure of pre-IND feedback supporting a 505(b)(2) route and the October 6 closing of the Gravitas acquisition. The remaining gating item before an NDA is the CMC program and commercial-scale registration batches, which the company intends to begin producing in 2027. Note the modeling results are predictions, not clinical outcomes, and the FDA has asked for revisions that could change them.
At the time of this announcement, HEPA was trading at $0.14 on OTC in the Life Sciences sector, with a market capitalization of approximately $13.8M. The 52-week trading range was $0.03 to $0.16. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: ACCESS Newswire.