Robbins LLP is Investigating Allegations that Savara Inc. (SVRA) Misled Investors About the Viability of its Lead Drug Candidate

Robbins LLP informs stockholders that a class action was filed on behalf of persons and entities that purchased or otherwise acquired Savara Inc. (NASAQ: SVRA) securities between March 7, 2024 and May 23, 2025. Savara is a clinical-stage biopharmaceutical company focused on rare respiratory diseases. The Company’s lead product candidate is MOLBREEVI (also referred to as “molgramostim”), an inhaled granulocyte-macrophage colony-stimulating (“GM-CSF”) factor.

The Allegations:

According to the complaint, during the class period, defendants failed to disclose that: (i) the MOLBREEVI Biologics License Application ("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.

Plaintiff alleges that 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, Savara’s stock price fell $0.90 per share, or 31.69%, to close at $1.94 per share on May 27, 2025.

What Now: You may be eligible to participate in the class action against Savara Inc. Shareholders who wish to serve as lead plaintiff for the class should contact Robbins LLP. The lead plaintiff is a representative party who acts on behalf of other class members in directing the litigation.  You do not have to participate in the case to be eligible for a recovery. If you choose to take no action, you can remain an absent class member.

All representation is on a contingency fee basis. Shareholders pay no fees or expenses.