MOLBREEVI (Molgradex) - (IMPALA-2)

August 11, 2026: Savara Inc. (NASDAQ: SVRA) said the BLA for MOLBREEVI (molgramostim inhalation solution) in autoimmune pulmonary alveolar proteinosis has an FDA PDUFA target action date of November 22, 2026. The company also said MAAs are under review by the EMA and the U.K. MHRA, with decisions expected in Q1 2027 and Q4 2026, respectively.

Savara said data presented at ATS showed molgramostim demonstrated continuous long-term improvements in lung function and respiratory health-related quality of life, though no numerical results were provided in the text. The company also reported European and Australian patent grants covering the MOLBREEVI liquid formulation through March 2041.

As of June 30, 2026, Savara had about $173.0 million in cash, cash equivalents, and short-term investments and about $30.1 million in debt. It also said up to about $150 million in non-dilutive capital would become available upon FDA approval. The company described the U.S. as its nearest-term regulatory and potential launch opportunity and said it is building commercial infrastructure ahead of a planned launch.