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 Announces Participation in Upcoming Healthcare ConferencesBusiness Wire
- Savara Reports Third Quarter 2024 Financial Results and Provides Business UpdateBusiness Wire
SVRA
Earnings
- 11/12/24 - In-Line
SVRA
Sec Filings
- 11/12/24 - Form 4
- 11/12/24 - Form 10-Q
- 11/12/24 - Form SC
- SVRA's page on the SEC website