Soleno Therapeutics Faces Legal Challenge Amid Launch Issues of Hyperphagia Drug VYKAT™ XR

Soleno Therapeutics in Legal Hot Water Over Hyperphagia Drug



Soleno Therapeutics, Inc. (NASDAQ: SLNO) finds itself in a precarious position following a recently filed securities class action lawsuit. This legal challenge aims to represent investors who purchased Soleno's common stock during a specific period from March 26, 2025, to November 4, 2025. The legal action follows a disappointing report issued by the company on November 5, 2025, regarding DCCR, marketed as VYKAT™ XR, which is designed to treat hyperphagia—a behavioral condition observed in individuals with Prader-Willi Syndrome (PWS).

PWS is an uncommon genetic disorder known for causing difficulties across various aspects of physical and mental health. The seriousness of hyperphagia in particular has been described by Soleno as the most life-altering facet of this condition. Despite initial optimism surrounding the drug's commercial prospects, the company's announcement led to a drastic decline in stock price, with shares plummeting by 26% the same day.

The controversy erupted following concerns about the safety and efficacy of VYKAT™ XR. Allegations surfaced that the company had understated or misrepresented safety issues related to DCCR, including serious risks of excess fluid retention observed in trial participants. Additionally, the lawsuit argues that Soleno's promotional statements regarding the launch have been both deceptive and misleading. The firm's confidence that the launch was exceeding expectations has come under fire as these safety concerns were made public.

Further complicating matters, activist short seller Scorpion Capital raised alarms back on August 15, 2025, ahead of the adverse report. Their investigation suggested that the number of children admitted to hospitals with potential heart failure shortly after using the drug hinted at serious consequences for VYKAT™ XR. The firm criticized Soleno’s reliance on a single physician in Gainesville, Florida, whose involvement in key trials and promotion of the new drug raised questions about the legitimacy of the data presented.

This situation deteriorated when Soleno's management acknowledged a disruption in the drug's launch trajectory following Scorpion's negative report, which correlated with a drop in new prescription starts and an increase in discontinuations due to non-serious adverse events.

As of November 5, 2025, Soleno shares had seen an almost 40% decline since Scorpion's report, which has significantly impacted investor sentiment. Reed Kathrein, the Hagens Berman partner leading the investigation, has stated the firm is looking into whether Soleno misled its investors concerning DCCR’s commercial viability and safety.

Hagens Berman is urging investors in Soleno who experienced considerable losses to come forward and share their experiences to aid in this class-action effort. A lead plaintiff deadline has been established for May 5, 2026, encouraging affected shareholders to take action before it’s too late.

In addition to financial implications, the company faces the potential fallout of losing investor trust and credibility within the competitive biotech sector—areas where transparency is paramount. As investigations continue, the spotlight will remain on Soleno Therapeutics to see how they navigate this challenging landscape.

This legal matter underscores the critical importance of ethical practices and accurate disclosures in the pharmaceutical industry, as both investors and patients closely monitor developments related to this controversial drug.

For those involved or impacted, Hagens Berman is equipped to offer assistance. Interested parties are encouraged to visit their website or contact them directly to discuss options regarding the ongoing investigation and potential class action lawsuit.

For more information, keep an eye on updates from law firms and health industry analysts as this situation continues to evolve.

Topics Health)

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