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Seralutinib Shows Mixed Results in Phase 3 PAH Trial, Winrevair Benefits Heart Failure-Related PH

Apr 02, 2026

Phase 3 trial results show seralutinib missed its primary endpoint in PAH but showed benefit in advanced disease subgroups. Meanwhile, Winrevair demonstrated significant reductions in pulmonary vascular resistance in heart failure-related pulmonary hypertension in a Phase 2 study.

Savara's Molbreevi Receives FDA Priority Review with August 22 PDUFA Date for Autoimmune PAP

Mar 02, 2026

The FDA has accepted Savara's Biologics License Application for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review, and set a PDUFA action date of August 22, 2026. The company plans to file marketing authorization applications in the EU and UK by the end of March.