Savara Announces European Medicines Agency (EMA) Validation of Marketing Authorization Application (MAA) for MOLBREEVI* in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Source: Business Wire
-- EMA Review of MOLBREEVI MAA Has Now Initiated, Decision Expected in Q1 2027 ---- MOLBREEVI Biologics License Application (BLA) is Currently Under Priority Review with the U.S. Food and Drug Administration (FDA), with an Action Date of August 22, 2026 ---- MOLBREEVI MAA Was Submitted to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) in March 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 EMA has validated the submission of the MOLBREEVI MAA in autoimmune PAP; the submission will now be reviewed by the Committee for Medicinal Products for Human Use (CHMP). In the U.S., the FDA is reviewing the MOLBREEVI BLA under Priority Review with an August 22, 2026 Action Date.“EMA’s validation of the MOLBREEVI MAA confirms the submission is complete and that the review of the application has begun,” said Matt Pauls, Chair and CEO, S
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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 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
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