Portnoy Law Firm Announces Class Action On Behalf Of Savara, Inc. Investors
Investors are encouraged to contact attorney Lesley F. Portnoy , by phone 844-767-8529 or email : ... , to discuss their legal rights, or join the case via . The Portnoy Law Firm can provide a complimentary case evaluation and discuss investors' options for pursuing claims to recover their losses.
Savara is a clinical stage biopharmaceutical company that focuses on rare respiratory diseases. Savara's lead product candidate is MOLBREEVI (also referred to as“molgramostim”), an inhaled granulocyte-macrophage colony-stimulating factor. In December 2024, Savara began a rolling submission of a Biologics License Application (“BLA”) to the U.S. Food and Drug Administration (“FDA”) for MOLBREEVI for the potential treatment of aPAP (the“MOLBREEVI BLA”).
The Savara class action lawsuit alleges that defendants throughout the Class Period made false and/or misleading statements and/or failed to disclose that: (i) the MOLBREEVI BLA lacked sufficient information regarding MOLBREEVI's chemistry, manufacturing, and/or controls; (ii) accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form; (iii) the foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors; and (iv) the delay in MOLBREEVI's regulatory approval increased the likelihood that Savara would need to raise additional capital.
The Savara class action lawsuit further alleges that, on May 27, 2025, Savara issued a press release“announc[ing] that the Company received [a refusal to file (“RTF”)] letter from the FDA for the [MOLBREEVI BLA] as a therapy to treat patients with [aPap]” and revealed that“[u]pon preliminary review, the FDA determined that the [MOLBREEVI BLA] was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC).” On this news, the price of Savara shares fell by more than 31%, according to the Savara class action lawsuit.
The Portnoy Law Firm represents investors in pursuing claims caused by corporate wrongdoing. The Firm's founding partner has recovered over $5.5 billion for aggrieved investors. Attorney advertising. Prior results do not guarantee similar outcomes.
Lesley F. Portnoy, Esq.
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310-692-8883
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