Savara Inc.

Savara Inc. initiated a rolling BLA submission to the FDA for MOLBREEVI, a potential treatment for aPAP, a rare lung disease. MOLBREEVI has Fast Track, Breakthrough Therapy, and Orphan Drug designations. The company expects to complete the BLA submission by end of 1Q 2025.

Savara Inc. initiated a rolling BLA submission to the FDA for MOLBREEVI, targeting aPAP treatment, expecting completion by Q1 2025. MOLBREEVI has Fast Track, Breakthrough Therapy, and Orphan Drug designations, with positive Phase 3 IMPALA-2 trial results. If approved, it could be the first aPAP treatment in the U.S. and Europe.

Savara Inc. announces encore presentation of IMPALA-2 trial results at BTS Winter Meeting on Nov 29, 2024, focusing on inhaled molgramostim's impact on aPAP patients.

Savara announces encore presentation of Phase 3 IMPALA-2 trial results for Molgramostim inhalation solution in aPAP patients at the British Thoracic Society Winter Meeting 2024, showcasing improved pulmonary gas exchange and respiratory health-related quality of life.

Savara reports Q3 2024 financials, plans BLA rolling submission for MOLBREEVI in aPAP by end of 2024, updates BLA completion to 1Q 2025, and expects MAA submission to EMA by end of 2025. The company has $219M in cash, sufficient through 2Q 2027.

Savara Inc. launches Savara Early Access Program to provide molgramostim for aPAP patients in regions where it's not yet commercially available, approved by the FDA. The program aims to address the high unmet need in aPAP, with broader availability planned by 2026 and a Biologics License Application submission to the FDA by mid-2025.

Savara Inc. announces the Savara Early Access Program, enabling physicians to request molgramostim for eligible aPAP patients in select geographies where it's not commercially available, pending local regulatory compliance. The program, reviewed by the FDA, accepts requests from eligible patients in North America and Europe, with plans to expand through 2026. Savara plans to submit a Biologics License Application for molgramostim in aPAP in the first half of 2025.