Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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US:NASDAQ Investor Relations:
savarapharma.com/investors/events-presentations
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Source: Business Wire
-- Priority Review Granted, Prescription Drug User Fee Act (PDUFA) Target Action Date Set for August 22, 2026 ---- Company Plans to Submit the MOLBREEVI Marketing Authorization Applications (MAAs) for Autoimmune PAP to the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) By the End of Q1 2026 ---- MOLBREEVI Has the Potential to Be the First and Only Approved Therapy for Autoimmune PAP in the U.S. and Europe -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, announced the FDA has filed for review the BLA for MOLBREEVI as a therapy to treat patients with autoimmune PAP. The FDA granted Priority Review with a PDUFA action date of August 22, 2026.“The FDA’s filing of the BLA marks another significant milestone for Savara and the autoimmune PAP community and brings us one step closer to a potential approval in the U.S. in August of
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News
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- 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
SVRA
Earnings
- 11/12/25 - Miss
SVRA
Sec Filings
- 2/17/26 - Form SCHEDULE
- 2/17/26 - Form 4
- 2/17/26 - Form SCHEDULE
- SVRA's page on the SEC website