Soleno Therapeutics Faces Class Action Lawsuit Over Drug Trial Concerns

Investors have until May 5, 2026, to file for lead plaintiff status in the securities fraud case.

Apr. 2, 2026 at 10:36pm

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An extreme close-up of highly detailed pharmaceutical manufacturing equipment, including pipes, valves, and control panels, conveying the complex industrial nature of drug production without using any text or identifiable elements.The complex industrial processes behind drug development are under scrutiny as Soleno Therapeutics faces allegations of concealing safety issues with its Prader-Willi syndrome treatment.Redwood City Today

A securities fraud class action lawsuit has been filed against Soleno Therapeutics, Inc. (NASDAQ: SLNO) on behalf of investors who purchased or acquired the company's common stock between March 26, 2025, and November 4, 2025. The lawsuit alleges that Soleno made material misstatements and/or omissions concerning the company's Phase 3 clinical trial program for its drug diazoxide choline extended-release tablets (DCCR).

Why it matters

The lawsuit claims that Soleno downplayed or concealed significant evidence of safety concerns related to the administration of DCCR, which could impact the drug's commercial viability and lead to adverse regulatory action, patient discontinuation, and reputational damage for the company.

The details

The complaint alleges that Soleno misrepresented and/or failed to disclose that the Phase 3 clinical trial program for DCCR had systematically downplayed, misrepresented, and/or concealed significant evidence of safety concerns potentially related to the administration of DCCR, including issues related to excess fluid retention in clinical trial participants. As a result, the administration of DCCR to treat hyperphagia in individuals with Prader-Willi syndrome (PWS) posed materially greater safety risks than disclosed by Soleno.

  • The class period is from March 26, 2025, through November 4, 2025.
  • Investors have until May 5, 2026, to file for lead plaintiff status.

The players

Soleno Therapeutics, Inc.

A pharmaceutical company focused on developing therapies for rare diseases and headquartered in Redwood City, California. At the time of the filing of the complaint, Soleno's only commercial product was DCCR for the treatment of hyperphagia in individuals afflicted with Prader-Willi syndrome.

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What they’re saying

“If you purchased or acquired Soleno common stock and have lost money on your investment, you are encouraged to contact KTMC attorney Jonathan Naji, Esq.”

— Jonathan Naji, Attorney, Kessler Topaz Meltzer & Check, LLP

What’s next

Investors have until May 5, 2026, to file for lead plaintiff status in the class action lawsuit.

The takeaway

This case highlights the importance of pharmaceutical companies being transparent about potential safety concerns with their drug candidates, as any issues could significantly impact the commercial viability and public perception of the product.