Savara Resubmits the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteino...
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Source: Business Wire
-- The BLA was Resubmitted with FUJIFILM Biotechnologies (Fujifilm) as the Drug Substance Manufacturer and Priority Review was Requested -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, announced today that it has resubmitted the MOLBREEVI BLA to the FDA, with Fujifilm as the drug substance manufacturer. The MOLBREEVI BLA submission is seeking approval for the treatment of autoimmune PAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli. The Company has requested Priority Review of the application.MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations by the FDA, Orphan Drug Designation by the FDA and by the European Medicines Agency (EMA), and Innovation Passport (IP) and Promising Innovative Medicine (PIM) designations by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) for
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News
- Savara Resubmits the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) [Yahoo! Finance]Yahoo! Finance
- Savara (NASDAQ:SVRA) had its price target raised by analysts at Wells Fargo & Company from $7.00 to $9.00. They now have an "overweight" rating on the stock.MarketBeat
- Savara Announces Participation in the 44th Annual J.P. Morgan Healthcare ConferenceBusiness Wire
- Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI* [Yahoo! Finance]Yahoo! Finance
- Savara Announces European Patent Office (EPO) Intends to Grant a Patent for the Liquid Formulation of MOLBREEVI*Business Wire
SVRA
Earnings
- 11/12/25 - Miss
SVRA
Sec Filings
- 12/19/25 - Form 4
- 12/18/25 - Form 144
- 12/16/25 - Form 4
- SVRA's page on the SEC website