NEW YORK, Oct. 02, 2025 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP reminds Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) investors of the November 7, 2025 to seek lead plaintiff appointment in the class action filed on behalf of investors who acquired Savara securities between March 7, 2024 through May 23, 2025 (“the Class Period”).

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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 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.

What Should I Do?

If you purchased or otherwise acquired Savara securities, have information, or would like to learn more about this investigation, please contact Thomas W. Elrod of Kirby McInerney LLP by email at investigations@kmllp.com, or fill out the form below, to discuss your rights or interests with respect to these matters without any cost to you.

[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