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: Yahoo! Finance
LANGHORNE, Pa., December 22, 2025 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 the treatment of autoimmune PAP. About Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) Autoimmune PAP is a r
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News
- Savara Announces Participation in Upcoming Investor Healthcare ConferencesBusiness Wire
- Savara Announces Amendment to Hercules Capital Debt Facility Providing up to $75M of Additional Debt Funding Upon U.S. Food and Drug Administration (FDA) Approval of MOLBREEVI*Business Wire
- SAVARA INVESTIGATION ALERT: Bragar Eagel & Squire, P.C. is Investigating Savara, Inc. on Behalf of Long-Term Stockholders and Encourages Investors to Contact the FirmGlobeNewswire
- Savara Announces New Employment Inducement GrantBusiness Wire
- With 37% stake, Savara Inc. (NASDAQ:SVRA) seems to have captured institutional investors' interest [Yahoo! Finance]Yahoo! Finance
SVRA
Earnings
- 11/12/25 - Miss
SVRA
Sec Filings
- 2/5/26 - Form SCHEDULE
- 1/27/26 - Form 8-K
- 1/21/26 - Form SCHEDULE
- SVRA's page on the SEC website