The company is seeking approval for Molbreevi to treat patients with Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP).
- The FDA is expected to decide on the company’s application by Aug. 22, 2026.
- Molbreevi had previously been granted FDA’s fast track, breakthrough therapy and orphan drug designations.
- The company also plans to submit applications to Europe’s EMA and the UK’s MHRA seeking approval for Molbreevi by the end of the first quarter of 2026.
Shares of Savara Inc. (SVRA) rallied over 3% after hours on Friday after the company announced that it has submitted an application to the U.S. Food and Drug Administration seeking approval for its experimental therapy Molbreevi.
The company is seeking approval for Molbreevi to treat patients with Autoimmune Pulmonary Alveolar Proteinosis (autoimmune PAP). The agency has granted the therapy priority review and is expected to decide on the application by Aug. 22, 2026.
Molbreevi had previously been granted FDA’s fast track, breakthrough therapy and orphan drug designations.
About Autoimmune PAP
Autoimmune PAP is a rare lung disease characterized by the abnormal build-up of surfactant, consisting of proteins and lipids, in the lung’s alveoli. While in a healthy lung surfactant is cleared, in autoimmune PAP it is left to accumulate causing impaired gas transfer, resulting in clinical symptoms of shortness of breath, often with cough and frequent fatigue.
The company now plans to submit applications to the European Medicines Agency (EMA) and the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) seeking approval for Molbreevi by the end of the first quarter of 2026.
“We believe the considerable body of data in the application demonstrates MOLBREEVI improves pulmonary gas transfer, quality of life, and the clinical symptoms associated with this rare and debilitating lung disease.” said CEO Matt Pauls.
How Did Stocktwits Users React?
On Stocktwits, retail sentiment around SVRA rose from ‘neutral’ to ‘bullish’ territory over the past 24 hours, while message volume remained at ‘high’ levels.
SVRA stock has more than doubled over the past 12 months.
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