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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News
- Savara Announces Encore Presentation of Results from the Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the British Thoracic Society Winter Meeting 2024 [YahooYahoo
- Savara Announces Encore Presentation of Results from the Phase 3 IMPALA-2 Trial of Molgramostim Inhalation Solution (Molgramostim) in Patients with Autoimmune Pulmonary Alveolar Proteinosis (aPAP) at the British Thoracic Society Winter Meeting 2024Business Wire
- Savara Inc (NASDAQ: SVRA) had its price target lowered by analysts at HC Wainwright from $10.00 to $6.00. They now have a "buy" rating on the stock.MarketBeat
- Savara Announces Participation in Upcoming Healthcare Conferences [Yahoo! Finance]Yahoo! Finance
- Savara Inc (NASDAQ: SVRA) had its "in-line" rating re-affirmed by analysts at Evercore ISI. They now have a $5.00 price target on the stock, down previously from $7.00.MarketBeat
SVRA
Earnings
- 11/12/24 - In-Line
SVRA
Sec Filings
- 11/20/24 - Form 4
- 11/18/24 - Form 4
- 11/14/24 - Form SC
- SVRA's page on the SEC website