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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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