Hepion Pharmaceuticals, Inc. - Common Stock (HEPA)

- In a simulation of 200 virtual subjects, a single dose of GV104 (16 mg nalmefene buccal film) taken at least 15 minutes before exposure prevented every potential fentanyl-induced cardiac arrest, at intravenous fentanyl doses known to be lethal in humans -- FDA re-affirmed the overall approach and provided comments that will improve the Company's ability to "demonstrate long-term prophylactic protection" -- The FDA comments are an important step in the path leading to an NDA. The Company intends to submit its response promptly -

- 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 -

- 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 -

Renocofilstat's Positive Outcomes Reinforce Antifibrotic Action Hepion Pharmaceuticals, a clinical stage biopharmaceutical company focusing on AI-assisted therapeutic drug development, recently