Savara reports positive Phase 3 IMPALA-2 results for molgramostim in aPAP; primary endpoint met

Savara Inc

Primary endpoint met: DLCO improved by 6.00% predicted at Week 24 vs placebo (p=0.0007).
Statistically significant improvement sustained at Week 48: DLCO 6.90% (p=0.0008).
SGRQ Total Score statistically significant at Week 24 (-6.59 points, p=0.0072); SGRQ Activity and exercise capacity nominally significant.
Well-tolerated; no drug-related discontinuations; 97% completed double-blind; all patients elected 96-week open-label.
Company plans to complete BLA submission to FDA in first half of 2025.

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