A securities class action has been filed against Savara Inc. (SVRA) on behalf of investors who acquired Savara securities between March 7, 2024 through May 23, 2025. This case has been filed in the USDC – EDPA.
On May 27, 2025, Savara issued a press release “announcing 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 complaint 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.