Hepion Pharmaceuticals Inc Stock News

- 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, a...

- 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 rat...