A class action lawsuit was filed against Savara Inc. (SVRA) on September 8, 2025. The plaintiffs (shareholders) alleged that they bought Savara stock at artificially inflated prices between March 7, 2024, and May 23, 2025 (Class Period) and are now seeking compensation for their financial losses. Investors who bought SVRA stock during that period can click here to learn about joining the lawsuit.
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Savara is a clinical-stage biopharmaceutical company focused on developing novel treatments for rare respiratory diseases, such as autoimmune pulmonary alveolar proteinosis (aPAP).
The company’s claims about its lead drug candidate, molgramostim, also referred to as Molbreevi, which is being developed to treat aPAP, are at the heart of the current complaint.
Savara’s Misleading Claims
According to the lawsuit, Savara and two of its senior officers (the Defendants) repeatedly made false and misleading public statements throughout the Class Period. In particular, they are accused of omitting truthful information about the likelihood of the U.S. Food and Drug Administration (FDA) accepting a Biologics License Application (BLA) for Molbreevi as presented, and ancillary issues, from SEC filings and related material.
In an annual report filed at the beginning of the Class Period, the company noted that its management team has strong experience in developing rare disease drugs and pulmonary medicine, finding unmet medical needs, and successfully bringing products to approval and the market.
Additionally, Savara said it believes molgramostim could become the preferred treatment for aPAP, as its characteristics may help achieve positive clinical results, regulatory approval, and successful commercialization.
Finally, in a November 12, 2024, press release, the CEO stated that after a productive meeting with the FDA, the company was working to start submitting its Biologics License Application (BLA) for Molbreevi by the end of 2024 and aimed to finish by early 2025, which could allow U.S. approval by the end of 2025 if given priority review.
However, subsequent events (detailed below) revealed that the defendants had failed to inform investors that Savara’s Molbreevi BLA lacked sufficient information regarding its chemistry, manufacturing, and/or controls. As a result, the FDA was unlikely to approve the Molbreevi BLA in its current form.
Plaintiffs’ Arguments
The plaintiffs maintain that the defendants deceived investors by lying and withholding critical information about the company’s business practices and prospects during the Class Period. Importantly, the defendants allegedly misled investors about the timeframe for submitting the BLA to the FDA and the related milestones.
The information became clear on May 27, 2025, when Savara issued a press release stating that it received a Refusal-to-File (RTF) letter from the FDA for its Biologics License Application (BLA) seeking approval of Molbreevi as a treatment for aPAP.
The company explained that, after an initial review, the FDA found the application incomplete and requested additional Chemistry, Manufacturing, and Controls (CMC) data before proceeding with a full evaluation. Following the news, SVRA stock collapsed 31.7%.
To conclude, the defendants failed to inform investors that it was unlikely Savara would complete its submission of the Molbreevi BLA within the timeframe it had represented to them. Additionally, the delay in Molbreevi’s regulatory approval increased the likelihood that Savara would need to raise additional capital. Despite these issues, SVRA stock has gained over 39% year-to-date.
