other material
confidence high
sentiment positive
materiality 0.90
Altimmune reports positive 48-week IMPACT data; FDA agrees on Phase 3 path for pemvidutide
Altimmune, Inc.
- Pemvidutide 1.8 mg reduced ELF by -0.58 (p<0.0001) and LSM by -3.97 (p<0.001) vs placebo at 48 weeks.
- Weight loss of 7.5% (1.8 mg, p<0.0001) vs 0.2% placebo; no plateau at 48 weeks; AE discontinuation 1.2% vs 3.5%.
- Proportion achieving both ELF ≥0.5 reduction and LSM ≥30% reduction: 32.4% (1.8 mg) vs 3.2% placebo (p<0.0001).
- End-of-Phase 2 FDA meeting on Dec 11 aligned on Phase 3 design; FDA open to AIM-MASH AI tool; plan to evaluate 2.4 mg dose.
- Altimmune raised ~$54.6M net from ATM sales of 13.5M shares after Sep 30, 2025.