Savara presents Phase 3 data showing Molbreevi improves lung function in autoimmune PAP
SVRA•Savara said its Phase 3 IMPALA-2 trial met its primary endpoint, with lung diffusion capacity 6 percentage points above placebo at week 24 and 6.9 points at week 48. The company highlighted a November 22, 2026, PDUFA date for MOLBREEVI.
1. Trial results
IMPALA-2 showed a 6-percentage-point lung diffusion capacity advantage over placebo at week 24 (p=0.0007), increasing to 6.9 percentage points at week 48 (p=0.0008). Respiratory quality-of-life scores improved versus placebo at week 24 (p=0.0072), while the week-48 difference was not statistically significant.
2. Treatment and review date
Treatment discontinuations were 3%, with none attributed to drug-related adverse events. Savara highlighted a November 22, 2026, PDUFA date for MOLBREEVI, its investigational inhaled treatment for autoimmune pulmonary alveolar proteinosis.
