FDA Backs 505(b)(2) Path for GV104 in Gambling Disorder, IND Targeted for 2027
HEPA has more than doubled off its 52-week low of $0.034.
Summary
The FDA's Division of Psychiatry gave written pre-IND feedback supporting a 505(b)(2) route for GV104, a buccal film of nalmefene, in gambling disorder — a condition with no approved medication. The agency said the nonclinical and manufacturing data already on file under a prior IND can be cross-referenced, that existing nonclinical work appears sufficient to support 12-week dosing, and that the planned Phase 2 proof-of-concept design and severity endpoint are generally appropriate. This follows the October 6 close of the Gravitas acquisition that brought GV104 in-house. The feedback is advisory and non-binding, and the company still needs to file a full IND, which it expects in 2027 — so no near-term revenue or trial start. For a micro-cap trading near a dime with going-concern doubt and cash projected to run out, the regulatory clarity is real but the funding question for a Phase 2 remains the bigger overhang.
At the time of this announcement, HEPA was trading at $0.10 on OTC in the Life Sciences sector, with a market capitalization of approximately $10.2M. The 52-week trading range was $0.03 to $0.13. This news item was assessed with positive market sentiment and an importance score of 7 out of 10. Source: ACCESS Newswire.