Hepion Gets FDA Feedback on Planned Gambling Disorder Drug Study
The FDA's Division of Psychiatry issued written responses to Hepion's Type B pre-IND meeting request, addressing the regulatory pathway, nonclinical package and planned Phase 2 study design. The agency said nonclinical and manufacturing data already on file under an IND may be cross-referenced.
Story updates
12:04:08 PM UTC
SquawkNews
Hepion Pharmaceuticals received FDA written feedback indicating its 505(b)(2) path and planned Phase 2 design for GV104 in gambling disorder are generally appropriate, with cross-reference to existing IND data allowed. The company expects to file an IND in 2027.Material DetailsContext by AI Analyst…