SVRA Stock Slips Post-Market After FDA Delays Decision On Pulmonary Therapy

• The company was looking for FDA’s greenlight for molgramostim in Autoimmune Pulmonary Alveolar Proteinosis.
• The company had submitted certain responses to the FDA recently which the agency determined represents a major amendment to the application, the company explained.
• Savara added that the agency did not cite any safety, efficacy, or manufacturing concerns in their correspondence.

Shares of Savara Inc. (SVRA) slumped as much as 4% after-hours on Wednesday after the company said that the U.S. Food and Drug Administration has extended the review time of its application seeking approval for its experimental therapy molgramostim by three months.

The company was looking for the FDA’s greenlight for molgramostim in Autoimmune Pulmonary Alveolar Proteinosis (Autoimmune PAP), a rare lung disease where autoantibodies block the clearing of surfactant in the lungs, causing a buildup that disrupts oxygen exchange, creating breathing difficulties, and chronic coughing.

The agency is now slated to decide on the application by November 22, Savara said. The former deadline for a decision was August 22.

Why The Delay?

The company had submitted certain responses to the FDA recently, which the agency determined represents a major amendment to the application, the company explained. The additional time will allow the agency time to review the extra materials submitted, it added.

Savara added that the agency did not cite any safety, efficacy, or manufacturing concerns in its correspondence.

Savara completed submission of its application to the FDA for molgramostim as a treatment for aPAP in March. It was granted priority review by the agency.  According to Savara, molgramostim has the potential to be the first and only approved therapy for Autoimmune PAP.

The company had previously submitted an application for the experimental therapy but received a “refuse to file” letter from the FDA in May 2025 due to insufficient Chemistry, Manufacturing, and Controls data. The company resubmitted the application, stating that Fujifilm Biotechnologies will manufacture the drug substance.  

How Did Stocktwits Users React?

On Stocktwits, retail sentiment around SVRA stock stayed within the ‘neutral’ territory over the past 24 hours, while message volume remained at ‘low’ levels.

SVRA stock has more than doubled over the past 12 months.

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