Soleno Therapeutics Faces Investor Lawsuit Over Alleged Safety Concerns

Bronstein, Gewirtz & Grossman LLC files class action alleging Soleno concealed risks with its drug DCCR

Apr. 6, 2026 at 4:15pm

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A photorealistic studio still life of a shattered glass vial or test tube on a clean, monochromatic background, conceptually representing the alleged safety issues with Soleno's drug.A shattered vial symbolizes the alleged safety concerns that could impact the commercial future of Soleno's drug candidate.NYC Today

A national law firm has filed a class action lawsuit against Soleno Therapeutics, Inc. on behalf of investors who purchased the company's securities between March 26, 2025 and November 4, 2025. The lawsuit alleges that Soleno failed to disclose significant safety concerns related to its drug DCCR, which is being developed to treat hyperphagia in individuals with Prader-Willi syndrome.

Why it matters

The lawsuit claims Soleno downplayed or misrepresented evidence of safety issues with DCCR, including concerns over excess fluid retention in clinical trial participants. This could impact the commercial viability and adoption of DCCR if the drug is approved, as well as expose Soleno to regulatory action, reputational damage, and potential legal fallout.

The details

The complaint alleges that Soleno's Phase 3 clinical trial program for DCCR systematically concealed significant evidence of safety concerns potentially related to the administration of the drug, including issues around excess fluid retention in participants. As a result, the lawsuit claims DCCR posed materially greater safety risks than what was disclosed by the company, which could lead to higher patient discontinuation rates, lower adoption, prescriber reluctance, and regulatory problems after any potential commercial launch.

  • The class period covers the time from March 26, 2025 to November 4, 2025.
  • Investors have until May 5, 2026 to request to be named as lead plaintiff in the lawsuit.

The players

Bronstein, Gewirtz & Grossman, LLC

A nationally recognized investor-rights law firm that has filed the class action lawsuit against Soleno Therapeutics on behalf of investors.

Soleno Therapeutics, Inc.

A biopharmaceutical company developing DCCR, a drug to treat hyperphagia in individuals with Prader-Willi syndrome.

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What they’re saying

“Our practice centers on restoring investor capital and ensuring corporate accountability, which serves to uphold the essential integrity of the marketplace.”

— Peretz Bronstein, Founding Partner, Bronstein, Gewirtz & Grossman, LLC

What’s next

The judge will decide by May 5, 2026 whether to appoint a lead plaintiff in the class action lawsuit against Soleno Therapeutics.

The takeaway

This lawsuit highlights the importance of transparency and full disclosure from pharmaceutical companies regarding the safety and risks of their drug candidates. Investors will be closely watching how this case unfolds and the potential impact on Soleno's future.