#United States #San Francisco #VYKAT XR #Soleno Therapeutics #DCCR

Soleno Therapeutics Faces Class Action Lawsuit Over VYKAT XR

Soleno Therapeutics, Inc., traded under the ticker SLNO, is currently embroiled in a securities class action lawsuit initiated by investors who purchased its stock during a specific period. This legal challenge arises in light of significant uncertainties surrounding the launch of its hyperphagia treatment, an oral tablet known as DCCR, branded as VYKAT XR.

The class action lawsuit was filed to represent those investors who acquired shares between March 26, 2025, and November 4, 2025. The lawsuit follows a troubling announcement on November 5, 2025, when Soleno disclosed that the commercial launch of DCCR did not meet expectations—described thereafter as experiencing significant hurdles. The release of this disappointing information instigated a severe 26% drop in the company's stock value, illuminating the precarious position in which Soleno now finds itself.

Hyperphagia, a hallmark of Prader-Willi Syndrome (PWS), is characterized as one of the most debilitating aspects of the disorder, which affects physical, mental, and behavioral health. This therapeutic created high hopes for both patients and their families seeking relief from the challenging symptoms of this genetic condition. However, the alleged malfeasance by Soleno regarding DCCR's efficacy, safety, and commercial viability is the crux of the lawsuit.

As reported, the litigation challenges the veracity of Soleno’s public statements that touted the favorable reception and successful launch trajectory of DCCR. The company promised that the drug’s rollout was exceeding expectations, but the reality presented in the lawsuit states otherwise, arguing that Soleno systematically downplayed and even concealed significant safety concerns associated with DCCR. For instance, troubling reports surfaced regarding adverse events linked to the administration of the drug during clinical trials, indicating potential risks that may have been omitted from public communications.

Activist short seller Scorpion Capital initially raised suspicions regarding Soleno’s disclosures on August 15, 2025. Their claims outlined a troubling pattern of health issues correlating with the drug's use, including several instances of children being hospitalized due to potential heart failure. This prompted a closer examination of Soleno's claims regarding DCCR’s commercial prospects, leading many investors to feel the ramifications of what they perceive as misleading information.

Furthermore, Scorpion suggested that Soleno relied heavily on a controversial lead investigator known for their association with key trials, which they alleged undermined the credibility of the data supporting DCCR's launch. Assertions of irregularities in the physician's research further fueled investor skepticism, sparking serious concerns regarding the integrity of Soleno’s claims to both the market and regulatory bodies.

Most recently, in a November earnings call, Soleno's management acknowledged a marked disruption in their launch efforts following the short seller report from August, citing lower initiation rates alongside heightened discontinuations. The fallout has been detrimental, as between August 14, 2025, and the day following the disappointing earnings call, Soleno’s share price plummeted by nearly 40%.

“Our investigation seeks to ascertain whether Soleno misled investors regarding the commercial prospects of its product, VYKAT XR,” said Reed Kathrein, an attorney from Hagens Berman leading the class action efforts. The firm urges current or former investors who suffered losses or have information valuable to the inquiry to come forward.

The lawsuit raises vital questions about the obligations of companies to provide truthful and comprehensive information to their stakeholders, particularly in industries such as biotechnology where public trust is pivotal to market success. As the litigation progresses, it may uncover critical insights regarding corporate behavior and regulatory compliance within the pharmaceutical sector, potentially influencing future investor confidence.

In addition to outlining the legal action, Hagens Berman encourages individuals possessing non-public information about Soleno to consider participating in the investigation under the SEC Whistleblower program, offering a chance for monetary rewards for cooperative behavior.

More information and comprehensive detail can be found on Hagens Berman's dedicated informational resources for those affected by the ongoing situation involving Soleno Therapeutics.