#United States #Class Action #San Francisco #VYKAT XR #Soleno Therapeutics

Soleno Therapeutics Under Fire in Class Action Lawsuit

A securities class action lawsuit has been initiated against Soleno Therapeutics, Inc. (NASDAQ: SLNO), representing investors who purchased shares between March 26, 2025, and November 4, 2025. The legal action comes after the company's disappointing update regarding DCCR, branded as VYKAT™ XR, which is aimed at treating hyperphagia—a condition linked to Prader-Willi Syndrome (PWS), a rare genetic disorder characterized by severe cognitive, behavioral, and physical challenges.

On November 5, 2025, Soleno disclosed unfavorable information about the drug, leading to a staggering 26% drop in its stock price the same day. This sharp decline has raised alarms among investors and prompted the national shareholders' rights law firm Hagens Berman to investigate potential discrepancies in the company's communications regarding DCCR's safety and efficacy.

According to the lawsuit, the plaintiffs allege that Soleno misrepresented various aspects concerning DCCR, which includes underplaying safety concerns that emerged during clinical trials. Specifically, the complaint highlights issues related to fluid retention that could significantly impact patient safety. Such misrepresentation has ostensibly affected the commercial viability of DCCR, with the lawsuit suggesting that the risks associated with the drug were either concealed or not adequately disclosed to investors.

Investor sentiment began to shift as early as August 2025, when activist short seller Scorpion Capital released a report questioning Soleno's disclosures. The report noted a concerning trend of children being hospitalized for suspected heart failure soon after the administration of VYKAT™ XR, casting doubt on the drug’s market potential. Additionally, Scorpion indicated that Soleno relied heavily on a particular physician from Gainesville, Florida, who directed critical trials. Allegations emerged about the integrity of this physician's research, sparking further skepticism about Soleno's data integrity in drug trials and FDA submissions.

Further complicating matters, in Soleno's Q3 2025 earnings call—the first after the detrimental short seller report—management openly acknowledged disruptions to the drug launch trajectory, citing lower numbers for new prescriptions and increased discontinuation rates for non-serious adverse events.

Investors are feeling the effects of this turmoil; since August 2025, Soleno's stock has plummeted by nearly 40%. As Hagens Berman continues its investigation, they are offering guidance for investors who experienced substantial losses and encouraging whistleblowers with non-public information to come forward, potentially under the SEC Whistleblower program, which could reward informants significantly.

The lawsuit’s deadline for lead plaintiff submission is set for May 5, 2026, and if you find yourself among the affected investors, now is the time to act. The ongoing developments highlight the delicate balance between corporate communications and market expectations in the pharmaceutical landscape, emphasizing the potential repercussions of misleading information on both regulators and the investing public.

If you're looking to understand more about this case, or have information that could contribute to the ongoing investigation, consider reaching out to Hagens Berman for assistance. The firm has established itself as a leader in advocating for corporate accountability, securing over $2.9 billion in settlements for investors and consumers harmed by corporate malfeasance. For those interested in staying updated, you can follow Hagens Berman for news regarding the class action and other patient advocacy developments as they unfold.