1. Savara faces a class action lawsuit from investors. 2. Lawsuit is linked to a significant FDA rejection. 3. Savara's share price dropped 31.69% following news. 4. Investors claim misleading statements by the company. 5. The lawsuit may impact Savara's financial stability.
The class action lawsuit and FDA rejection signal severe operational challenges. Historical instances show such issues can lead to long-term stock decline.
The class action lawsuit could deter potential investors and create a loss of confidence in Savara's management.
The implications of regulatory delays and potential financial strain can affect Savara's future viability and stock performance significantly.
The law firm of Kirby McInerney LLP announces that a class action lawsuit has been filed on behalf of investors who acquired Savara Inc. ("Savara" or the "Company") (NASDAQ:SVRA) securities during the period of March 7, 2024 through May 23, 2025, inclusive ("the Class Period").
If you suffered a loss on your Savara investments, you have until November 7, 2025 to request lead plaintiff appointment. Follow the link below for more information:
[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 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 contact form below, to discuss your rights or interests with respect to these matters at no cost.
[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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20250909028393/en/
Kirby McInerney LLP
Thomas W. Elrod, Esq.
212-699-1180
https://www.kmllp.com
investigations@kmllp.com