Savara Inc.

Case Overview
60 Days Left to Seek Lead Plaintiff
Lead Plaintiff Deadline: | Lead Plaintiff Deadline: 11/07/2025 |
Status: | Status: Investigating |
Company Name: | Company Name: Savara Inc. |
Court: | Court: Eastern District of Pennsylvania |
Case Number: | Case Number: 2:25cv05147 |
Class Period: | Class Period: 03/07/2024 - 05/23/2025 |
Ticker: | Ticker: SVRA |
Related Attorneys: | Lead Attorneys: Thomas W. Elrod |
Related Practices: | Related Practices: Securities |
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”).
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.
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.
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.
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.