Savara Granted Breakthrough Therapy Designation for Molgradex for the Treatment of Autoimmune Pulmonary Alveolar Proteinosis (aPAP)
Savara, Inc. (SVRA)
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Source: Business Wire
AUSTIN, Texas--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for Molgradex, an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of aPAP.Breakthrough Therapy designation is a process designed to expedite the development and review of drugs that are intended to treat a serious condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).1The Molgradex Breakthrough Therapy designation is based on data from IMPALA, a pivotal Phase 3 clinical study evaluating Molgradex for the treatment of aPAP. Data from the study was recently presented in an oral session at the 2019 European Respiratory Society (ERS) International Congress in Madrid, Spain.“We are pleased that the FDA r
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- Savara Inc (NASDAQ: SVRA) had its "market outperform" rating re-affirmed by analysts at JMP Securities. They now have a $8.00 price target on the stock.MarketBeat
- Savara to Present New Data on Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2024 [Yahoo! Finance]Yahoo! Finance
- Savara to Present New Data on Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the American Thoracic Society (ATS) International Conference 2024Business Wire
- Savara Announces New Employment Inducement GrantBusiness Wire
- Savara Reports Fourth Quarter/Year-End 2023 Financial Results and Provides Business Update [Yahoo! Finance]Yahoo! Finance
SVRA
Earnings
- 11/9/23 - Miss
SVRA
Sec Filings
- 4/26/24 - Form ARS
- 4/26/24 - Form DEFA14A
- 4/26/24 - Form DEF
- SVRA's page on the SEC website