Savara Inc.

On May 27, 2025, Savara issued a press release announcing that the U.S. Food and Drug Administration (“FDA”) had issued a refusal-to-file letter for the Company’s Biologics License Application (“BLA”) for its autoimmune pulmonary alveolar proteinosis treatment, MOLBREEVI, determining that the submission was not sufficiently complete and requesting additional Chemistry, Manufacturing, and Controls data. That same day, Guggenheim published a report lowering its price target for Savara and warning of potential delays in commercialization and the likelihood of additional capital raises.

On this news, Savara’s stock price fell $0.90, or 31.7%, to close at $1.94 per share on May 27, 2025, thereby injuring investors.

The complaint filed in this class action alleges that throughout the Class Period, Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts about the Company’s business, operations, and prospects. Specifically, Defendants failed to disclose to investors that: (1) the MOLBREEVI BLA lacked sufficient information regarding MOLBREEVI’s chemistry, manufacturing, and/or controls; (2) accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form; (3) the foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors; (4) the delay in MOLBREEVI’s regulatory approval increased the likelihood that the Company would need to raise additional capital; and (5) as a result, Defendants’ positive statements about the Company’s business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.