#USA #San Francisco #investor scrutiny #VYKAT XR #Soleno Therapeutics

Soleno Therapeutics Under Fire Following VYKAT™ XR Launch Issues

On November 5, 2025, shares of Soleno Therapeutics, Inc. (NASDAQ: SLNO) plummeted nearly 28%, resulting in a significant financial hit for investors. This steep decline followed the company’s announcement of disappointing early sales and troubling reports related to its recently launched medication, VYKAT™ XR. The oral tablet was developed to treat hyperphagia, a detrimental symptom associated with Prader-Willi syndrome – a rare genetic disorder leading to various health issues.

The Context of the Decline

In September 2025, shortly after receiving FDA approval, Soleno had projected a robust commercial launch for VYKAT™ XR. Executives emphasized that initial sales were exceeding expectations. However, as recent disclosures suggest, sales did not materialize as hoped. During their Q3 earnings call on November 4, company representatives disclosed a disruption in the expected launch trajectory, revealing fewer prescriptions and an uptick in discontinuations due to non-serious adverse events.

The situation gained further scrutiny in light of a report published by Scorpion Capital on August 15, which raised alarms about the safety and efficacy of VYKAT™ XR. The report indicated that a concerning number of children had been hospitalized with potential heart failure shortly after beginning treatment. This news led to suspicions about the drug’s viability and raised questions regarding Soleno’s overall operational integrity.

Investigative Actions and Concerns

In response to the stock's downturn, the national law firm Hagens Berman has launched an investigation into whether Soleno misled investors regarding the market prospects of VYKAT™ XR. They are seeking individuals who may have experienced significant financial losses as a result of these events. The firm has highlighted critical inconsistencies in Soleno’s previous public statements, particularly those made just before the disappointing earnings report. Reed Kathrein, the Hagens Berman partner leading the investigation, pointed to the potential implications of the disclosures.

Given that VYKAT™ XR is Soleno's primary asset, its failure could jeopardize the entire company. Concerns have also been raised regarding the lack of a diverse product pipeline, as Soleno's future hinges largely on the success of this single product. In their reports, Scorpion has branded Soleno as a ‘one-trick pony’ and suggested that any issues faced by VYKAT™ XR could lead to a catastrophic fallout for the company.

The Implications of the Allegations

The allegations regarding a controversial physician tied to the product's development have further compounded investor concerns. This physician was involved in key trials and raised questions about irregularities found in some of the related publications. Investors are left to ponder the integrity of conducted trials, medical publications, and the submission processes to the FDA.

The significant decline in Soleno’s stock price since the start of August has not only raised eyebrows among investors but has also prompted speculation about the firm’s longer-term strategies. With the patent for their primary product set to expire in 2026, investors are increasingly apprehensive about the company’s future.

What Lies Ahead for Soleno

As investigations progress, it remains to be seen how Soleno Therapeutics will respond to the growing concerns surrounding VYKAT™ XR and its operational integrity. The firm’s communications with shareholders in the coming months will be crucial. If the investigation reveals any wrongdoing, it could lead to further consequences for the company, including potential financial liabilities and a haunting loss of trust among investors.

In the wake of these overwhelming challenges, stakeholders in Soleno Therapeutics are urged to remain vigilant. Misleading communications in the biopharmaceutical sector can have far-reaching implications, and investors must prioritize transparency and ethical business practices. Soleno’s next moves will certainly warrant close observation from both the market and legal authorities as they seek to navigate this turbulent phase.