Savara Announces FDA Response From Type C Meeting on Molgradex for aPAP Development Program
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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Source: Business Wire
AUSTIN, Texas--(BUSINESS WIRE)--Savara Inc. (Nasdaq: SVRA), an orphan lung disease company, today announced the response from a Type C meeting with the U.S. Food and Drug Administration (FDA) regarding the Molgradex development program for autoimmune pulmonary alveolar proteinosis (aPAP). Molgradex is an inhaled formulation of recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF).In the written response received by Savara on October 1, the FDA indicated that the data provided in the briefing package do not provide sufficient evidence of efficacy and safety and did not recommend that the Company submit a Biologics License Application (BLA). The Company is working to determine the next steps for the Molgradex development program.“While we are disappointed in the FDA’s response, considering the IMPALA study results presented today at the ERS annual conference, we remain committed to the Molgradex development program and believe that it will provide aPAP patients
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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