Savara Announces the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Has Accepted the MOLBREEVI* Marketing Authorisation Application (MAA) for Autoimmune Pulmonary Alveolar...
Savara, Inc. (SVRA)
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Source: Business Wire
-- MHRA’s Acceptance Follows Acceptance/Validation of MOLBREEVI Biologics License Application (BLA) and MAA in Autoimmune PAP by the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), Respectively -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that the MHRA has accepted the submission of the MOLBREEVI MAA for the treatment of autoimmune PAP in the U.K. The MAA was accepted under Accelerated Review and qualifies for a 150-day assessment duration. A decision on the application is expected in Q4 2026.In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Prescription Drug User Fee Act (PDUFA) date. In Europe, the MOLBREEVI MAA is being reviewed by the Committee for Medicinal Products for Human Use (CHMP) with a decision expected in Q1 2027.“Marketing applications for MOLBREEVI in autoimm
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News
- Savara Announces New Employment Inducement GrantBusiness Wire
- 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 Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)Business Wire
- Savara To Present New Data at the American Thoracic Society (ATS) 2026 International ConferenceBusiness 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