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Savara Inc. INVESTOR ALERT: Kirby McInerney LLP Reminds Savara Inc. Investors of Looming Lead Plaintiff Deadline in Class Action Lawsuit

Key Takeaway: Savara Inc. is facing a class action lawsuit due to allegations that it made misleading statements about its MOLBREEVI biologics license application (BLA). Following an FDA refusal to file the BLA, Savara's stock price fell sharply by nearly 32%. Investors affected by the decline have until November 7, 2025, to file as lead plaintiffs in the lawsuit. The case centers on claims that Savara inadequately disclosed issues related to chemistry, manufacturing, and controls that could hinder regulatory approval and compel the company to raise additional capital.
Price reaction · baseline $3.43 (2025-10-07 close) · hit after-hours · 1 other SVRA headline(s) in the window, move may be shared
day 0 close · peak
+1.2%

Market Sentiment Analysis

CONCERNS & RISKS

  • Savara's shares declined significantly after the FDA refused to file the MOLBREEVI BLA, leading to a loss of approximately 31.69%.
  • The lawsuit claims that Savara made false or misleading statements regarding the BLA's sufficiency and regulatory approval likelihood.
  • There is uncertainty surrounding the company's ability to complete the submission of the MOLBREEVI BLA in a timely manner.

BiopharmaWatch Analysis

From our catalyst data and publicly available data · not financial advice
Best trade, last catalyst
+22%
120-day peak, hindsight
Typical move
10.4%
average across 3 past catalysts
Cash runway
~13 mo
Low dilution risk
Lead asset
MST-188
Phase 3 · Vaso-occlusive Crisis

Full Press Release Details

NEW YORK, Oct. 08, 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]
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.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Thomas W. Elrod, Esq.

Frequently Asked Questions

What caused the decline in Savara's share price?

Savara's share price dropped by approximately 31.69% after the company announced a refusal to file letter from the FDA regarding the MOLBREEVI BLA.

Who can join the class action lawsuit?

Investors who purchased Savara securities from March 7, 2024, to May 23, 2025, may join the class action.

What allegations are made in the lawsuit?

The lawsuit claims Savara made misleading statements about the MOLBREEVI BLA's approval process and regulatory status.

When is the deadline to file for lead plaintiff?

Investors have until November 7, 2025, to request appointment as lead plaintiff in the lawsuit.

What firm is handling this class action?

Kirby McInerney LLP, a New York-based law firm, is representing the investors in this class action.

Last updated: Oct 8, 2025