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Molgramostim (MOLBREEVI)

Autoimmune Pulmonary Alveolar Proteinosis (aPAP)

Phase 3Active; Regulatory Review (MAA validated by EMA Mar 2026)

Key Facts

Indication
Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Phase
Phase 3
Status
Active; Regulatory Review (MAA validated by EMA Mar 2026)
Companies

About Savara Pharmaceuticals

Savara Inc. is a clinical-stage biopharmaceutical company with a mission to develop and commercialize novel, best-in-class therapies for rare respiratory diseases. Its core achievement is the advancement of molgramostim, an inhaled GM-CSF, into late-stage development for autoimmune pulmonary alveolar proteinosis (aPAP), with a Marketing Authorization Application (MAA) validated by the European Medicines Agency in March 2026. The company's strategy is to become a leader in rare respiratory therapeutics by concentrating resources on high-unmet-need orphan indications, exemplified by its focused pipeline and management team with extensive rare disease and pulmonary drug development experience.

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About Savara

Savara is a clinical-stage biopharmaceutical company with a mission to develop and commercialize novel therapies for rare respiratory diseases, starting with autoimmune pulmonary alveolar proteinosis (aPAP). Its core achievement is the advancement of its lead candidate, molgramostim, into Phase 3 development with a validated Marketing Authorization Application (MAA) under review by the European Medicines Agency. The company's strategy centers on targeted pulmonary delivery of GM-CSF to correct a fundamental disease mechanism, aiming to secure regulatory approvals and establish a commercial footprint in the global orphan drug market. Savara's experienced leadership team, with proven track records in rare disease commercialization, is executing this focused plan to transition into a commercial-stage entity.

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Other Autoimmune Pulmonary Alveolar Proteinosis (aPAP) Drugs

DrugCompanyPhase
MolgramostimPARI PharmaNDA