Savara’s Molbreevi Gains FDA Priority Review with Aug. 22 PDUFA Date
FDA accepted Savara’s BLA for Molbreevi in autoimmune PAP with priority review and an Aug. 22, 2026 PDUFA date. Phase III IMPALA showed DLCO, SGRQ, exercise capacity and surfactant burden improvements; Savara holds $264M cash and up to $150M of contingent funding.
1. FDA Priority Review and PDUFA Date
The FDA has accepted and filed Savara’s BLA for Molbreevi in autoimmune pulmonary alveolar proteinosis, granted priority review and set a PDUFA date of August 22, 2026. Management views this as the final regulatory milestone ahead of potential U.S. approval.
2. Phase III IMPALA Efficacy Data
Data from the Phase III IMPALA program demonstrated improvements in diffusing capacity of the lung for carbon monoxide (DLCO), St. George’s Respiratory Questionnaire scores, exercise capacity and surfactant burden, reinforcing Molbreevi’s macrophage-activating mechanism to address the underlying disease pathology.
3. Commercial and Regulatory Plans
Savara intends to file marketing authorization applications in the European Union and United Kingdom by the end of March and has selected PANTHERx Rare as its exclusive specialty pharmacy partner. The company is preparing a 30-person U.S. field team to drive disease awareness and testing ahead of potential launch.
4. Cash Position and Contingent Funding
Savara reported $264 million in cash reserves and has secured up to $150 million in contingent non-dilutive financing through a royalty agreement and a debt facility, ensuring funding to support operations through the PDUFA decision.