Savara Initiates Rolling Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmona...
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Source: Yahoo! Finance
LANGHORNE, Pa., December 18, 2024 BUSINESS WIRE Savara Inc. (Nasdaq: SVRA ) (the Company), a clinical stage biopharmaceutical company focused on rare respiratory diseases, initiated a rolling submission of a BLA to the FDA for MOLBREEVI for the potential treatment of aPAP, a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. MOLBREEVI was granted Fast Track and Breakthrough Therapy Designations in 2019 for the treatment of patients with aPAP. As a result, the Company is allowed to submit individual modules of the BLA as they are completed rather than waiting to submit the application once all modules are available. The Company will request a priority review of the BLA when the submission is completed. "Given the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe MOLBREEVI demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated," said Matt Pauls,
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SVRA
News
- Savara Announces New Employment Inducement GrantBusiness Wire
- Savara Inc (NASDAQ: SVRA) is now covered by analysts at Wells Fargo & Company. They set an "overweight" rating and a $8.00 price target on the stock.MarketBeat
- Savara Inc (NASDAQ: SVRA) had its "market outperform" rating re-affirmed by analysts at JMP Securities. They now have a $9.00 price target on the stock.MarketBeat
- Savara Initiates Rolling Submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for MOLBREEVI* for the Potential Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)Business Wire
- Savara Announces Participation in the 43rd Annual J.P. Morgan Healthcare ConferenceBusiness Wire
SVRA
Earnings
- 11/12/24 - In-Line
SVRA
Sec Filings
- 12/16/24 - Form 4
- 12/16/24 - Form 4
- 12/16/24 - Form 4
- SVRA's page on the SEC website