Savara posts corporate presentation focused on autoimmune pulmonary alveolar proteinosis and MOLBREEVI program
SVRA•Phase 3 data and FDA timeline for MOLBREEVI
Savara outlined Phase 3 IMPALA-2 data for MOLBREEVI (molgramostim inhalation solution) in autoimmune PAP ahead of a U.S. FDA decision.
- Primary endpoint met: DLCO improved 9.8 points at Week 24 vs. 3.8 for placebo; between-group difference 6.0; p=0.0007.
- Week 48 DLCO improved 11.6 vs. 4.7; between-group difference 6.9; p=0.0008.
- SGRQ total score improved -11.5 vs. -4.9 at Week 24; difference -6.59; p=0.0072; Week 48 p=0.1046.
- BLA PDUFA date set for Nov. 22, 2026; no approved drugs in the U.S. or Europe for autoimmune PAP.
