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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.
More on Savara
- Savara Inc. (SVRA) Presents at 44th Annual J.P. Morgan Healthcare Conference Transcript
- Savara resubmits MOLBREEVI BLA to FDA, seeks priority review
- Seeking Alpha’s Quant Rating on Savara
- Historical earnings data for Savara
- Financial information for Savara
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