Lawsuit filed for Investors who lost money with shares of Savara Inc. (NASDAQ: SVRA)

An investor, who purchased shares of Savara Inc. (NASDAQ: SVRA), filed a lawsuit over alleged violations of Federal Securities Laws by Savara Inc. in connection with certain allegedly false and misleading statements.

Investors who purchased shares of Savara Inc. (NASDAQ: SVRA) have certain options and for certain investors are short and strict deadlines running. Deadline: November 7, 2025. NASDAQ: SVRA investors should contact the Shareholders Foundation at mail@shareholdersfoundation.com or call +1(858) 779 - 1554.

Langhorne, PA based Savara Inc., a clinical stage biopharmaceutical company, focuses 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").

On May 27, 2025, Savara Inc announced that the U.S. Food and Drug Administration ("FDA") had issued a refusal-to-file letter for the Company's Biologics License Application ("BLA") for its autoimmune pulmonary alveolar proteinosis treatment, MOLBREEVI, determining that the submission was not sufficiently complete and requesting additional Chemistry, Manufacturing, and Controls data. That same day, Guggenheim published a report lowering its price target for Savara and warning of potential delays in commercialization and the likelihood of additional capital raises.

Shares of Savara Inc. (NASDAQ: SVRA) declined from $5.60 per share on March 7, 2024, to as low as $1.89 per share on May 27, 2025.

The plaintiff claims that between March 7, 2024 and May 23, 2025, the Defendants failed to disclose to investors that the MOLBREEVI BLA lacked sufficient information regarding MOLBREEVI's chemistry, manufacturing, and/or controls, that accordingly, the FDA was unlikely to approve the MOLBREEVI BLA in its current form, that the foregoing made it unlikely that Savara would complete its submission of the MOLBREEVI BLA within the timeframe it had represented to investors, that the delay in MOLBREEVI's regulatory approval increased the likelihood that the Company would need to raise additional capital, and that as a result, Defendants' positive statements about the Company's business, operations, and prospects were materially misleading and/or lacked a reasonable basis at all relevant times.

Those who purchased shares of Savara Inc. (NASDAQ: SVRA) have certain options and should contact the Shareholders Foundation.

Contact:
Michael Daniels
Shareholders Foundation, Inc.
3111 Camino Del Rio North
Suite 423
San Diego, CA 92108
Tel: +1-(858)-779-1554
E-Mail: mail@shareholdersfoundation.com

About Shareholders Foundation, Inc.
The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, and an investor advocacy group, which does research related to shareholder issues and informs investors of securities lawsuits, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigations, and/or settlements are not filed/initiated/reached and/or are not related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.

This release was published on openPR.