Portnoy Law Firm Announces Class Action on Behalf of Savara, Inc. Investors

Core Viewpoint - Savara, Inc. is facing a class action lawsuit due to alleged misleading statements regarding its lead product candidate, MOLBREEVI, and its Biologics License Application (BLA) submission to the FDA [1][4]. Company Overview - Savara is a clinical stage biopharmaceutical company focused on rare respiratory diseases [3]. - The company's lead product candidate is MOLBREEVI (molgramostim), an inhaled granulocyte-macrophage colony-stimulating factor [3]. - In December 2024, Savara began a rolling submission of a BLA to the FDA for MOLBREEVI to treat aPAP [3]. Legal Issues - The class action lawsuit alleges that Savara made false or misleading statements and failed to disclose critical information about the MOLBREEVI BLA, including insufficient data on chemistry, manufacturing, and controls [4]. - The lawsuit claims that the FDA was unlikely to approve the MOLBREEVI BLA in its current form, which could delay the submission timeline and necessitate additional capital raising [4]. - On May 27, 2025, Savara announced it received a refusal to file (RTF) letter from the FDA, stating the BLA was not sufficiently complete for review, leading to a more than 31% drop in share price [5].