Hepion Pharmaceuticals Receives Positive FDA Response on GV104 in Gambling Disorder, a Condition With No Approved Medication- FDA's Division of Psychiatry issued written responses to a Type B pre-IND meeting request covering the regulatory pathway, the nonclinical package, and the design of a planned Phase 2 study-- Confirmed that the nonclinical and manufacturing data already on file under an IND may be cross-referenced to the new program, and stated that a planned Phase 2 proof-of-concept design is, in general, appropriate -- There are no FDA-approved medications for gambling disorder; Company anticipates filing an IND for GV104 and commencing the path toward a Phase 2 study in 2027 -
Hepion Pharmaceuticals Completes Acquisition of Gravitas Life Sciences and Provides Corporate Update- Acquisition adds GV104, a clinical-stage opioid countermeasure with a 505(b)(2) pathway and an active investigational new drug application, and GV023, an oral formulation of an approved anti-TNF antibody -- FDA has stated in writing that additional clinical studies do not appear to be necessary to define the prophylactic dosing window for GV104, placing the critical path in manufacturing rather than in new clinical work -- Transaction creates a three-program portfolio spanning therapeutics and diagnostics, and Hepion intends to advance its circulating tumor RNA diagnostic toward a laboratory-developed test in 2027 -
Hepion Pharmaceuticals (NASDAQ: HEPA) Reports Promising Phase 2 Trial Results for NASH TreatmentRenocofilstat's Positive Outcomes Reinforce Antifibrotic Action Hepion Pharmaceuticals, a clinical stage biopharmaceutical company focusing on AI-assisted therapeutic drug development, recently
