Hepion Receives FDA Support for Planned Phase 2 Trial of GV104 in Gambling Disorder

• Hepion Pharmaceuticals received FDA feedback supporting the general design of subsidiary Gravitas Life Sciences’ planned Phase 2 GV104 trial for gambling disorder.
• Gravitas expects to file an investigational new drug application in 2027; the trial design remains subject to FDA review.
• The FDA permitted cross-referencing existing nonclinical and manufacturing data, potentially supporting a 12-week study without repeating earlier work.
• The planned trial will evaluate GV104 as an addition to psychosocial care for gambling disorder, which has no FDA-approved medication.
• FDA guidance outlined a potential 505(b)(2) approval pathway relying partly on prior agency findings for an approved nalmefene product.

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