FDA将审查Savara重新提交的Molbreevi BLA

2026-02-21 05:42

The U.S. FDA will review Savara's (SVRA) resubmitted BLA for Molbreevi (molgramostim inhalation solution) to treat the rare lung disease autoimmune pulmonary alveolar proteinosis.
The agency granted priority review with an action date of Aug. 22.
The candidate is a recombinant human granulocyte-macrophage colony-stimulating factor.
Savara said it would submit applications to the European Medicines Agency and the UK's Medicines and Healthcare Products Regulatory Agency by the end of Q1.
The company resubmitted the BLA in December.
Shares are up ~4.5% in after-hours trading Friday.

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