Time-Sensitive: Allegations Focus on Undisclosed Commercial Viability and Adverse Event Risks

Levi & Korsinsky, LLP alerts investors in Soleno Therapeutics, Inc. (NASDAQ: SLNO) of a pending securities class action. Class Period: March 26, 2025 through November 4, 2025. Check if you can recover your investment losses or contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com | (212) 363-7500.

A class action has been filed in the U.S. District Court for the Northern District of California alleging that Soleno and certain executives made materially misleading statements about VYKAT XR (DCCR), the Company's sole commercial product for treating hyperphagia in Prader-Willi syndrome patients. The Court has set May 5, 2026 as the deadline to apply for lead plaintiff appointment.

Alleged Undisclosed Risks to DCCR's Commercial Future

While management repeatedly touted VYKAT XR's commercial trajectory and "exceptionally encouraging" launch reception, the lawsuit asserts that the Company concealed a cascade of risks that directly threatened the drug's long-term viability. The action claims these undisclosed dangers extended far beyond the safety profile itself and into the commercial foundations of Soleno's only revenue-generating product.

According to the lawsuit, management knew or recklessly disregarded that DCCR carried materially lower commercial viability than represented, including:

• Undisclosed risks of significant and widespread adverse events following commercial launch, including reports of severe fluid retention, pre-diabetes, and potential heart failure symptoms in patients
• Risk of elevated patient discontinuation rates as adverse reactions emerged in real-world settings, contradicting claims that discontinuation rates were "substantially lower than what we saw even in clinical trials"
• Risk of lower patient adoption as the initial wave of desperate families willing to try any new treatment subsided
• Growing prescriber reluctance among endocrinologists and trial investigators, many of whom indicated they had no plans to prescribe the drug and were advising colleagues to refrain
• Potential reputational and legal fallout as patient reports of serious harm accumulated on social media and within the PWS community

The Commercialization Disconnect

The lawsuit contends that management painted an aggressively optimistic picture of VYKAT XR's commercial prospects. As late as August 6, 2025, management described the drug as "on its way to being the standard of care" and characterized the launch as "a very strong start," while claiming "there are no new safety signals" in the post-marketing setting. The action alleges these representations omitted the growing body of evidence that the drug's commercial foundation was eroding.

Speak with an attorney about recovering damages or call (212) 363-7500.

"Investors deserve transparency about material risks that could affect their investments. When a company's only commercial product faces undisclosed threats to patient adoption, prescriber willingness, and regulatory standing, those risks are plainly material to shareholders evaluating the company's future." -- Joseph E. Levi, Esq.

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