Savara Completes Submission of the Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* as a Treatment for Autoimmune Pulmonary Alveolar Protei...
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Company Research
Source: Business Wire
-- Priority Review Was Requested, Commercial Launch Preparations Underway ---- MOLBREEVI Has the Potential to Be the First and Only Approved Therapy for aPAP in the U.S. and Europe ---- Company Remains on Track to Submit the Marketing Authorization Application (MAA) in Europe by the End of 2025 -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has completed submission of the BLA to the FDA for MOLBREEVI as a treatment for aPAP.“Submission of the BLA marks an important milestone for the Company and the aPAP community,” said Matt Pauls, Chair and Chief Executive Officer, Savara. “We believe this unprecedented body of data demonstrates MOLBREEVI improves pulmonary gas exchange and the clinical symptoms associated with this rare lung disease. As part of the submission, Priority Review was requested and, if granted, would shorten the FDA’s review to six mo
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SVRA
News
- 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
- Savara Inc. ticks higher amid takeover speculation [Seeking Alpha]Seeking Alpha
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