Important Notice Regarding Alleged DCCR Safety Data Misrepresentations
NEW YORK, March 16, 2026 (GLOBE NEWSWIRE) — Levi & Korsinsky, LLP notifies investors in Soleno Therapeutics, Inc. (NASDAQ: SLNO) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between March 26, 2025 and November 4, 2025. Find out if you qualify to recover losses. You may also contact Joseph E. Levi, Esq. at [email protected] or (212) 363-7500.
The lawsuit contends that Soleno’s Phase 3 clinical trial program for DCCR (marketed as VYKAT XR) systematically downplayed significant evidence of safety concerns, including excess fluid retention, elevated diabetes risk, and potential pulmonary edema in clinical trial participants. The lead plaintiff deadline is May 5, 2026.
How Alleged Safety Concealment Affected DCCR’s Commercial Profile
DCCR was the first FDA-approved treatment for hyperphagia in individuals with Prader-Willi syndrome, a rare genetic condition affecting an estimated 300,000 to 400,000 individuals worldwide. The drug was priced at approximately $500,000 per year per patient, and Soleno generated $32.7 million in net revenue from DCCR sales during the quarter ended June 30, 2025.
According to the lawsuit, the commercial viability of DCCR depended on the integrity of the safety data underlying its approval. The complaint alleges that the Company’s clinical trial program concealed or minimized alarming safety signals that, once revealed, threatened patient adoption, prescriber willingness, and the drug’s long-term commercial trajectory.
Key Safety Allegations for Shareholders
The complaint and subsequent investigative reporting allege:
– Diazoxide’s mechanism of action causes fluid retention that set the stage for pulmonary edema and congestive heart failure in PWS patients
– Clinical trial data allegedly showed an alarming spike in prediabetes and diabetes within 13 weeks of starting DCCR, with a linear increase over three years and no signs of a plateau
– Two patients in the 13-week Phase 3 trial may have been admitted for symptoms consistent with pulmonary edema and potential heart failure, but the events were allegedly downplayed
– Many trial investigators interviewed expressed sharp criticism of the drug and indicated they had no plans to prescribe it
– Social media groups for VYKAT XR users documented reports of inability to walk due to fluid buildup, hospitalizations, and blood sugar spiking to diabetic levels
– The Company’s efforts to characterize fluid retention as an increase in lean body mass allegedly obscured a shocking 16-pound steady and linear increase over three years of treatment
Submit your information to join this case
or call (212) 363-7500.
“This case presents important questions about drug safety disclosure obligations in the rare disease pharmaceutical sector. When a company’s only commercial product carries undisclosed safety risks of this magnitude, shareholders deserve to know before they invest.” — Joseph E. Levi, Esq.
The Diazoxide Safety Factor
DCCR consists of diazoxide choline, a choline salt of a compound used for over 50 years in hospital settings. The lawsuit alleges that the known mechanism of diazoxide, which blocks insulin secretion and promotes fluid retention, created foreseeable safety risks that were not adequately disclosed to investors. The complaint further contends that the Company’s clinical trials were structured in ways that minimized the appearance of these risks, including the use of a subjective caregiver questionnaire as the primary efficacy endpoint.
ABOUT LEVI & KORSINSKY, LLP — Over the past 20 years, Levi & Korsinsky has secured hundreds of millions of dollars for aggrieved shareholders. The firm has extensive expertise in complex securities litigation and a team of over 70 employees. For seven consecutive years, Levi & Korsinsky has ranked in ISS Securities Class Action Services’ Top 50 Report. Applications to serve as lead plaintiff must be filed by May 5, 2026.
CONTACT:
Levi & Korsinsky, LLP
Joseph E. Levi, Esq.
Ed Korsinsky, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
Tel: (212) 363-7500
Fax: (212) 363-7171
