Savara Faces FDA Setback for MOLBREEVI Application

Savara ( (SVRA) ) has issued an announcement.

On May 27, 2025, Savara Inc. announced it received a refusal to file letter from the FDA for its Biologics License Application for MOLBREEVI, aimed at treating autoimmune pulmonary alveolar proteinosis. The FDA’s refusal was due to incomplete Chemistry, Manufacturing, and Controls data, not safety concerns, and Savara plans to address these issues and resubmit the application by the fourth quarter of 2025. The refusal does not affect previous designations granted to MOLBREEVI, and the company remains confident in its program and is working on establishing a redundant supply chain.

The most recent analyst rating on (SVRA) stock is a Buy with a $10.00 price target. To see the full list of analyst forecasts on Savara stock, see the SVRA Stock Forecast page.

Spark’s Take on SVRA Stock

According to Spark, TipRanks’ AI Analyst, SVRA is a Neutral.

Savara’s stock score reflects a company in the developmental stage, with significant financial risks due to its lack of revenue and ongoing cash burn. However, a strong balance sheet and recent financing developments provide some stability. Technical indicators suggest short-term positive momentum, but valuation remains challenging with a negative P/E ratio. The recent loan agreement is a positive step, potentially facilitating future growth and commercialization efforts.

To see Spark’s full report on SVRA stock, click here.

More about Savara

Savara Inc. is a clinical-stage biopharmaceutical company that focuses on developing treatments for rare respiratory diseases. Their lead program, MOLBREEVI, is a recombinant human granulocyte-macrophage colony-stimulating factor (GM-CSF) in Phase 3 development for autoimmune pulmonary alveolar proteinosis (autoimmune PAP).

Average Trading Volume: 1,018,085

Technical Sentiment Signal: Sell

Current Market Cap: $490.9M

See more insights into SVRA stock on TipRanks’ Stock Analysis page.