Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)
Savara, Inc. (SVRA)
Last savara, inc. earnings: 3/12 04:05 pm
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US:NASDAQ Investor Relations:
savarapharma.com/investors/events-presentations
Company Research
Source: Business Wire
-- Day 74 Letter Received from the U.S. Food and Drug Administration (FDA) Indicated the Agency Has No Plans to Convene an Advisory Committee ---- Company has Submitted the Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) ---- Submission of the MAA to the U.K. Medicines and Healthcare Products Regulatory Agency (MHRA) Remains on Track by the End of Q1 2026 -- LANGHORNE, Pa.--(BUSINESS WIRE)--Savara Inc. (the “Company”) (Nasdaq: SVRA), a clinical-stage biopharmaceutical company focused on rare respiratory diseases, today announced that it has received the Day 74 Letter from the FDA which indicated that an Advisory Committee meeting is not planned for the MOLBREEVI Biologics License Application (BLA) and the review is ongoing with a Prescription Drug User Fee Act (PDUFA) target action date of August 22, 2026.Additionally, the Company recently submitted the MAA to the EMA for MOLBREEVI for the treatment of autoimmune PAP and is on track to submit the MA
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News
- Savara Provides Regulatory Update on the MOLBREEVI* Development Program in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP) [Yahoo! Finance]Yahoo! Finance
- Savara (SVRA) Is Down 8.0% After FDA Grants Priority Review To MOLBREEVI - What's Changed [Yahoo! Finance]Yahoo! Finance
- Savara Announces Participation in 2026 Citizens Life Sciences ConferenceBusiness Wire
- Savara Highlights FDA Priority Review for Molbreevi as Aug. 22 PDUFA Date Nears [Yahoo! Finance]Yahoo! Finance
- Savara Announces the U.S. Food and Drug Administration (FDA) Filed the MOLBREEVI* Biologics License Application (BLA) in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP)Business Wire
SVRA
Earnings
- 11/12/25 - Miss
SVRA
Sec Filings
- 2/17/26 - Form SCHEDULE
- 2/17/26 - Form 4
- 2/17/26 - Form SCHEDULE
- SVRA's page on the SEC website