SLNO Investor Alert: Soleno Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Company Allegedly Concealed Drug Safety Risks: SueWallSt
Important Notice Regarding Alleged DCCR Safety Data Misrepresentations
NEW YORK, April 23, 2026 /PRNewswire/ -- SueWallSt 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 (888) SueWallSt.
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:
Submit your information to join this case or call (888) SueWallSt.
"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:
SueWallSt
Joseph E. Levi, Esq.
33 Whitehall Street, 27th Floor
New York, NY 10004
[email protected]
Tel: (888) SueWallSt
Fax: (212) 363-7171
SOURCE SueWallSt.com