NEW YORK, Oct. 30, 2025 (GLOBE NEWSWIRE) -- Pomerantz LLP announces that a class action lawsuit has been filed against Savara Inc. (“Savara” or the “Company”) (NASDAQ: SVRA) and certain officers.   The class action, filed in the United States District Court for the Eastern District of Pennsylvania, and docketed under 25-cv-05147, is on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Savara securities between March 7, 2024 and May 23, 2025, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.

If you are an investor who purchased or otherwise acquired Savara securities during the Class Period, you have until November 7, 2025, to ask the Court to appoint you as Lead Plaintiff for the class.  A copy of the Complaint can be obtained at www.pomerantzlaw.com.   To discuss this action, contact Danielle Peyton at newaction@pomlaw.com or 646-581-9980 (or 888.4-POMLAW), toll-free, Ext. 7980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.  

[Click here for information about joining the class action]

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 factor. MOLBREEVI is in a Phase 3 IMPALA-2 pivotal clinical trial for the treatment of autoimmune pulmonary alveolar proteinosis (“aPAP”), a chronic and debilitating rare lung disease characterized by the abnormal build-up of surfactant in the alveoli of the lungs. Savara has consistently represented that, based on investments in MOLBREEVI and its purported “track record of strong fiscal discipline,” the Company is “sufficiently capitalized” as early as through 2026 and as late as into the second half of 2027.

In December 2024, Savara began a rolling submission of a Biologics License Application (“BLA”)—i.e., a submission requesting approval to distribute a biologic product across state lines—to the United States (“U.S.”) Food and Drug Administration (“FDA”) for MOLBREEVI for the potential treatment of aPAP (the “MOLBREEVI BLA”). In a press release announcing the submission, the Company touted that, “[g]iven the positive results of the pivotal, Phase 3 IMPALA-2 trial, we believe MOLBREEVI demonstrates a favorable benefit-risk profile and could fundamentally change the way aPAP is treated,” and that “[i]nitiation of the [MOLBREEVI] BLA is an important milestone in potentially addressing the unmet need in aPAP, for which there are no approved medicines in the U.S. and Europe.” Moreover, Savara represented that it “expect[ed] to complete the submission of the rolling [MOLBREEVI] BLA by the end of [the first quarter of] 2025.”

To obtain FDA approval of the MOLBREEVI BLA, Savara must submit, among other things, information regarding MOLBREEVI’s chemistry, manufacturing, and controls (“CMC”). Specifically, the CMC section of a BLA must provide a detailed account of a product’s manufacturing process—including process validation runs, stability testing, and analytical method validation—and detailed descriptions of facilities, equipment, and quality control procedures.

The Complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and prospects. Specifically, Defendants 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; (iv) the delay in MOLBREEVI’s regulatory approval increased the likelihood that the Company would need to raise additional capital; and (v) as a result, Defendants’ public statements were materially false and misleading at all relevant times.

On May 27, 2025, Savara issued a press release “announc[ing] that the Company received [a refusal to file] 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).”

Market analysts were quick to comment on the Company’s announcement. For example, on May 27, 2025, Guggenheim published a report (the “Guggenheim Report”) revising its price target for Savara to $8.00, down from the previous $9.00. Guggenheim stated that it “do[es] not expect Savara to be profitable on a continuing basis until 2028 and expect[s] the company may raise additional capital, potentially through a secondary stock offering that could dilute the holdings of current investors.” In addition, the Guggenheim Report noted that the “CMC Delay Could Lead to Change in Molbreevi Manufacturing Strategy,” predicting a delayed market launch sometime in early 2027, a year later than initially expected.

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.

Then, after the end of the Class Period, on August 13, 2025, Savara issued a press release announcing the Company’s financial results for the second quarter of 2025. Among other things, the press release revealed that, contrary to the Company’s prior representations that it would complete its rolling submission of the MOLBREEVI BLA in the first quarter of 2025, Savara now “plan[s] to resubmit the [MOLBREEVI] BLA in December [2025].”

Pomerantz LLP, with offices in New York, Chicago, Los Angeles, London, Paris, and Tel Aviv, is acknowledged as one of the premier firms in the areas of corporate, securities, and antitrust class litigation. Founded by the late Abraham L. Pomerantz, known as the dean of the class action bar, Pomerantz pioneered the field of securities class actions. Today, more than 85 years later, Pomerantz continues in the tradition he established, fighting for the rights of the victims of securities fraud, breaches of fiduciary duty, and corporate misconduct. The Firm has recovered billions of dollars in damages awards on behalf of class members. See www.pomlaw.com. 

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CONTACT:
Danielle Peyton
Pomerantz LLP
dpeyton@pomlaw.com
646-581-9980 ext. 7980