SLNO Investor Alert: Soleno Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Conducting Sham Clinical Trials: Levi & Korsinsky

Alert: Claims Focus on Alleged Misrepresentations About Clinical Trial Integrity and Drug Safety

NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky, LLP reminds purchasers of Soleno Therapeutics, Inc. (NASDAQ: SLNO) securities of a pending securities class action.

THE CASE: A class action seeks to recover damages for investors who purchased Soleno securities between March 26, 2025 and November 4, 2025.

YOUR OPTIONS: You may be entitled to compensation without payment of any out-of-pocket fees. See if you can recover losses or contact Joseph E. Levi, Esq. at [e-mail] or [phone].

Soleno's sole commercial product, DCCR (marketed as VYKAT XR), is a diazoxide choline extended-release tablet for treating hyperphagia in patients with Prader-Willi syndrome. The drug's FDA approval rested entirely on Soleno's Phase 3 clinical trial program, including a pivotal 16-week randomized withdrawal study. Investors have until May 5, 2026 to seek lead plaintiff status.

How DCCR Reaches Patients and Why Trial Integrity Allegedly Matters

A pharmaceutical company cannot sell a drug without FDA approval. That approval depends on demonstrating safety and efficacy through well-controlled clinical trials. For Soleno, the entire commercial opportunity for DCCR hinged on one pivotal study: the randomized withdrawal period of Study C602. If that study's data was unreliable, the foundation for the drug's approval, its commercial launch, and Soleno's revenue was fundamentally compromised.

The lawsuit contends that Soleno's Phase 3 program suffered from systematic problems that defendants knew about or recklessly disregarded.

Alleged Clinical Trial Deficiencies by the Numbers

- The pivotal randomized withdrawal study enrolled only 77 participants, an unusually small sample, with enrollment allegedly skewed heavily toward a single clinical site

- The original 13-week Phase 3 trial (DESTINY PWS, n=127) failed to meet its primary endpoint for hyperphagia improvement, as the filing states

- Investigators reportedly identified placebo bias from unblinding caused by visible side effects such as hypertrichosis (excessive hair growth) and edema, as well as differing smell between drug and placebo

- Many investigators interviewed by an independent research firm allegedly expressed sharp criticism of trial conduct and indicated no plans to prescribe the drug

- A number of endocrinologists across major academic centers and PWS clinics reportedly expressed similar skepticism about the drug's safety profile

- The action claims defendants obscured a linear increase in prediabetes and diabetes markers over three years of treatment with no plateau

Fluid Retention and the Alleged Safety Concealment

The complaint recounts that fluid retention is inherent to diazoxide's mechanism of action. As detailed in the action, two patients in the 13-week Phase 3 trial may have been admitted for symptoms consistent with pulmonary edema and potential heart failure, but these events were allegedly downplayed. The lawsuit chronicles how the prevalence of edema appeared to increase the longer patients used the drug, with no apparent plateau, suggesting a tipping point between discontinuation or a serious safety event.

Despite these concerns, management repeatedly told investors the drug had a "well-established safety profile" and that "no new safety signals" had emerged in the postmarketing setting.

Calculate your potential recovery or call [phone].

"The complaint raises serious questions about whether investors received accurate information regarding the integrity of the clinical data underpinning DCCR's approval and commercial launch." -- Joseph E. Levi, Esq.

Levi & Korsinsky, LLP -- Top 50 securities litigation firm (ISS, seven consecutive years). Over 70 professionals. Hundreds of millions recovered.