Altimmune reports Q3 loss of $31.6m as pemvidutide MASH Phase 3 stays on track
The US biotech says PERFORMA is progressing, with 52-week topline data due in 2029, and an FDA End-of-Phase 2 meeting on alcohol use disorder is set for December.
Altimmune reported its third-quarter 2026 results on 12 November, disclosing a net loss of $31.6 million and $480 million in cash and investments.
The company said the Phase 3 PERFORMA trial of pemvidutide in metabolic dysfunction-associated steatohepatitis (MASH) is progressing. Topline data at 52 weeks are expected in 2029.
Altimmune also has an FDA End-of-Phase 2 meeting scheduled for December 2026 to discuss a Phase 3 programme for pemvidutide in alcohol use disorder (AUD). Such meetings are a standard step in US drug development, allowing sponsors to align with the agency on late-stage trial design before pivotal studies begin.
The meeting follows presentation of Phase 2 RECLAIM data at the AASLD meeting and the award of Fast Track designation for AUD. The summary on file does not give details of the RECLAIM results or of the planned Phase 3 design.
Why it matters
- The outcome of the December FDA meeting will shape the Phase 3 design and endpoints for pemvidutide in AUD, which regulatory teams tracking the programme should monitor.
- PERFORMA's 52-week readout is not expected until 2029, so MASH-related market-access planning for this asset remains long-term.
- Fast Track designation for AUD may allow more frequent interaction with the FDA during development.
Company's press release (SEC filing): Altimmune, Inc. ↗
Written by CompePharma's editorial system from the company's filing; claims are the company's. AI-assisted; check the source before acting. Not investment advice.
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