NEW YORK, Oct. 06, 2025 (GLOBE NEWSWIRE) -- If you have suffered a loss on your Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) investment, contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the contact form below to discuss your rights or interests in the securities fraud class action lawsuit at no cost.
Investors have until November 7, 2025 to ask the Court to appoint them as lead plaintiff.
[CONTACT THE FIRM IF YOU SUFFERED A LOSS]
What Happened?
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].” Specifically, Savara 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 declined by $0.90 per share, or approximately 31.69%, from $2.84 per share on May 23, 2025 to close at $1.94 on May 27, 2025.
What Is The Lawsuit About?
The lawsuit has been filed on behalf of investors who purchased securities during the period of March 7, 2024 through May 23, 2025, inclusive (“the Class Period”). The lawsuit alleges that the Company 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 the Company would need to raise additional capital.
[CLICK HERE TO LEARN MORE ABOUT THE CLASS ACTION]
Kirby McInerney LLP is a New York-based plaintiffs’ law firm concentrating in securities, antitrust, whistleblower, and consumer litigation. The firm’s efforts on behalf of shareholders in securities litigation have resulted in recoveries totaling billions of dollars. Additional information about the firm can be found at Kirby McInerney LLP’s website.
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Contacts
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-699-1171
https://www.kmllp.com
investigations@kmllp.com
