Savara Announces the U.S. Food & Drug Administration (FDA) Has Extended the Review Period for the Molgramostim Inhalation Solution (Molgramostim) Biologics License Application (BLA) in Aut...
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Source: Business Wire
-- Prescription Drug User Fee Act (PDUFA) Target Action Date Extended by Three Months to November 22, 2026 -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the FDA has extended the review period for the molgramostim BLA in autoimmune PAP by three months. The Agency is reviewing the molgramostim BLA under Priority Review and the new PDUFA target action date is November 22, 2026.The FDA determined that the Company’s responses to recent information requests by the Agency constituted a major amendment to the BLA, resulting in a three-month extension of the PDUFA date. The Agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence. This extension allows the FDA additional time to complete their review of the BLA, including recently submitted materials related to information requests.In addition to Fast Track and Breakthrough
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News
- Savara Announces New Employment Inducement GrantBusiness Wire
- Savara To Present New Data at the American Thoracic Society (ATS) 2026 International ConferenceBusiness Wire
- Savara Announces the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Has Accepted the MOLBREEVI* Marketing Authorisation Application (MAA) for Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)Business Wire
- Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) [Yahoo! Finance]Yahoo! Finance
- Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)Business Wire
SVRA
Earnings
- 11/12/25 - Miss
SVRA
Analyst Actions
- 3/16/26 - HC Wainwright
SVRA
Sec Filings
- 4/10/26 - Form PRE
- 3/20/26 - Form 4
- 3/13/26 - Form 8-K
- SVRA's page on the SEC website