Hepion Pharmaceuticals Acquires Gravitas Life Sciences

With FDA's written determination that no additional clinical studies are needed to define GV104's prophylactic dosing window, Hepion Pharmaceuticals has effectively moved the critical path for this opioid countermeasure from the clinic to the manufacturing floor. The company completed its acquisition of Gravitas Life Sciences, LLC on October 6, 2026, adding two licensed programs and reshaping its regulatory pipeline under a 505(b)(2) NDA framework.

GV104 is a transmucosal buccal film of an approved opioid antagonist, developed for temporary prophylaxis of respiratory and central nervous system depression in military personnel and chemical incident responders. The active IND application remains in place, and FDA's March 2025 written statement positions the remaining work squarely around manufacturing process development and validation rather than new clinical endpoints. For plant heads and QA directors, that framing is consequential: the path to NDA submission depends on demonstrating manufacturing control for a novel buccal film delivery form of a molecule with an established safety profile.

The second acquired asset, GV023, is an oral formulation of infliximab, an approved anti-TNF antibody conventionally administered by infusion or injection. The program targets delivery to inflamed lower-gut tissue and has not yet entered human studies. Its near-clinical status means formulation development and early process characterisation work will define the near-term regulatory timeline.

The 505(b)(2) pathway for GV104 allows Hepion to reference FDA's prior findings on the approved injectable reference product, but the agency's remaining open items centre on manufacturing rather than efficacy. Regulatory affairs teams tracking novel delivery form submissions will recognise the pattern: when the clinical question is resolved by reference drug data, CMC documentation, process validation, and sterility or extractables data for the delivery system become the inspection-ready deliverables that determine submission readiness.

On October 9, 2026, the Board appointed Sireesh Appajosyula, PharmD, formerly CEO of Gravitas Life Sciences and a Hepion board member since March 2026, as Chief Executive Officer. Gary Stetz, previously Interim CEO, moves to Chief Financial Officer. Appajosyula has been involved with the acquired programs since 2023, providing continuity across the transition.

Hepion's three-asset portfolio now spans GV104, GV023, and an in-licensed circulating tumor RNA diagnostic, which the company intends to advance toward a laboratory-developed test in 2027. The manufacturing readiness of GV104's buccal film platform will be the first measurable checkpoint against which the combined organisation's execution can be assessed.

Source: Hepion Pharmaceuticals via ACCESS Newswire, October 14, 2026.