Hepion Subsidiary Gravitas Receives FDA Guidance on GV104 for Gambling Disorder

• Hepion Pharmaceuticals' wholly owned subsidiary Gravitas Life Sciences received FDA feedback on GV104's development for gambling disorder, which has no approved medication.
• The FDA outlined a 505(b)(2) application pathway relying partly on prior findings for an approved nalmefene product.
• Regulators found the planned Phase 2 design generally appropriate, with existing nonclinical studies potentially sufficient to support 12 weeks of dosing.
• Gravitas can cross-reference nonclinical and manufacturing data from a previous investigational new drug application.
• The subsidiary anticipates filing an investigational new drug application in 2027; the final Phase 2 design remains subject to FDA review.

Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Hepion Pharmaceuticals Inc. published the original content used to generate this news brief via ACCESS Newswire (Ref. ID: 202610190801ACCESSWRNAPR_____1238047) on October 19, 2026, and is solely responsible for the information contained therein.