SLNO Investor Alert: Soleno Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Misrepresenting DCCR Safety Timeline: SueWallSt

Key Dates and Disclosure Events Shareholders Need to Know

NEW YORK, March 26, 2026 /PRNewswire/ -- SueWallSt encourages investors who suffered losses in Soleno Therapeutics, Inc. (NASDAQ: SLNO) to contact the firm. Those who purchased SLNO securities between March 26, 2025 and November 4, 2025 may be entitled to recover damages. Find out if you are eligible to recover losses . You may also contact Joseph E. Levi, Esq. at [email protected]  or (888) Suewallst.

Soleno's only commercial product, VYKAT XR (diazoxide choline extended-release tablets), received FDA approval on March 26, 2025, for hyperphagia in individuals with Prader-Willi syndrome. A securities class action alleges that between that date and November 4, 2025, Soleno and its executives issued a series of escalating public assurances about the drug's safety and commercial trajectory while allegedly concealing serious adverse event risks, including excess fluid retention, pre-diabetes, and potential heart failure in patients.

March 26, 2025: FDA Approval and Initial Safety Assurances

Soleno announced FDA approval and held a conference call during which the drug was described as having a "well-established safety profile with over four years of data." The label was highlighted as containing no boxed warning, no contraindication for diabetes, and no requirement for a REMS program. The lawsuit contends these statements omitted known concerns about fluid retention and metabolic risks observed during clinical trials.

May 7, 2025: First Quarter Results and Momentum Claims

Soleno reported its first quarter results and filed a Form 10-Q certified by its CEO and CFO. Public statements described "high level of interest" in the drug and claimed the company was "very well positioned to sustain our current momentum." The action alleges these filings repeated safety claims that were already materially incomplete.

June 10, 2025: Goldman Sachs Conference Presentation

At the Goldman Sachs Global Healthcare Conference, Soleno's CFO presented safety data to analysts, claiming only two severe adverse events across the entire clinical program and describing side effects as "typically, self-limiting." The complaint chronicles this presentation as further minimizing risks that were allegedly more significant than disclosed.

August 6, 2025: Second Quarter Results and Safety Denials

Soleno reported $32.7 million in DCCR revenue and held a conference call during which management stated there were "no new safety signals" in the post-marketing setting and that discontinuation rates were "substantially lower than what we saw even in clinical trials." The securities action claims these statements were the culmination of a pattern of alleged concealment.

Submit your claim before the deadline  or call (212) 363-7500.

August 15, 2025: Scorpion Capital Report

Scorpion Capital published a 415-page report detailing interviews with clinical trial investigators, Soleno employees, and medical professionals. The report alleged that the drug carried high risks of pre-diabetes, pulmonary edema, and congestive heart failure; that trial investigators broadly rejected VYKAT XR; and that clinical trials exhibited suspect data and results. Patient reports on social media described severe fluid retention, hospitalizations, and discontinuations.

"Timely disclosure of material developments is fundamental to fair and efficient markets. The chronology in this case raises questions about whether investors received accurate safety information at each critical juncture."  -- Joseph E. Levi, Esq.

The window to apply for lead plaintiff closes on May 5, 2026.

ABOUT THE FIRM -- For over two decades, Levi & Korsinsky has represented shareholders in securities class actions. Ranked in ISS Top 50 for seven consecutive years.

CONTACT:
Levi & Korsinsky, LLP
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