Altimmune’s Pemvidutide Wins FDA Breakthrough, Secures $340M Runway
Altimmune’s pemvidutide received FDA Breakthrough Therapy designation for MASH and will enter a single pivotal Phase 3 trial enrolling ~1,800 patients with 1.8 mg and 2.4 mg arms and 52-week histologic endpoints intended for accelerated approval. The company reported $274 million cash at end-2025 and $340 million pro forma liquidity, funding operations into 2028.
1. FDA Breakthrough Designation and Phase 3 Design
Pemvidutide earned FDA Breakthrough Therapy status for metabolic dysfunction-associated steatohepatitis and will advance into a global Phase 3 trial enrolling approximately 1,800 patients. The single pivotal study features a 990-patient biopsy cohort and an 800-patient non-invasive test cohort, testing titration to 1.8 mg or 2.4 mg over 52 weeks with histologic endpoints aimed at accelerated approval.
2. Phase 2 Data Supports Dose Selection and Tolerability
Chief Medical Officer Christophe Arbet-Engels highlighted 48-week Phase 2 IMPACT data showing anti-fibrotic effects and early MASH resolution at week 24, with dose response favoring 1.8 mg and comparable efficacy to approved products. Improvements in ELF scores, liver stiffness, ALT and cT1 imaging were noted, alongside low gastrointestinal adverse events informing a simplified one- or two-step titration scheme.
3. Cash Position Fuels Operations into 2028
Altimmune closed 2025 with $274 million in cash and a pro forma $340 million following January financings. Management expects this liquidity to underwrite rising Phase 3 preparations and operations through 2028, despite increased cash burn in 2026.
4. Upcoming AUD and ALD Readouts
The Phase 2 RECLAIM trial in alcohol use disorder completed enrollment in Q4 2025, with top-line results due in Q3 2026. The Phase 2 RESTORE study in alcohol-related liver disease remains ongoing, with enrollment expected to finish later in 2026.