#USA #New York #Lawsuit #Soleno Therapeutics #DCCR

Soleno Therapeutics Faces Legal Action Over Alleged Safety Data Misrepresentation

Overview
Investors in Soleno Therapeutics, Inc. (NASDAQ: SLNO) have been alerted that a class action lawsuit has been initiated on behalf of shareholders who acquired securities between March 26, 2025, and November 4, 2025. This legal action arises from claims that Soleno Therapeutics concealed significant safety risks associated with its drug DCCR (marketed as VYKAT XR), designed to treat hyperphagia in Prader-Willi syndrome patients. Legal representatives have urged affected investors to determine their eligibility to join the lawsuit and potentially recover losses.

Background of the Allegations
The lawsuit asserts that the Phase 3 trial program for DCCR understated considerable safety concerns, such as excessive fluid retention, heightened diabetes risk, and potential pulmonary edema in clinical trial participants. With a lead plaintiff deadline set for May 5, 2026, the case raises crucial questions about the responsibility of pharmaceutical companies to disclose comprehensive safety data, particularly in the rare disease drug sector.

DCCR, hailed as the first FDA-approved medication for treating hyperphagia linked to Prader-Willi syndrome, carries an annual price of around $500,000 per patient. Soleno's sales of DCCR yielded net revenues of approximately $32.7 million in the quarter ending June 30, 2025. The lawsuit argues that the drug's commercial success relied heavily on maintaining the trust of investors regarding the safety data that supported its approval.

Key Safety Issues Spotlighted in the Lawsuit
The complaint elaborates on the dangerous safety aspects allegedly omitted or downplayed by the company. Key issues raised include:

• - The mechanism of action for diazoxide, a primary ingredient in DCCR, reportedly leads to fluid retention that may result in pulmonary edema and congestive heart failure for patients with Prader-Willi syndrome.
• - Data from clinical trials purportedly disclosed a concerning rise in prediabetes and diabetes cases within just 13 weeks of starting DCCR, indicating a continual incline without a plateau observed over a three-year period.
• - Two individuals involved in the Phase 3 trial may have been hospitalized due to symptoms indicative of pulmonary edema and heart failure; however, these incidents were allegedly understated by the company.
• - Feedback from trial investigators has been overwhelmingly critical, with many expressing hesitations about prescribing the drug.
• - Social media discussions among DCCR users highlighted severe side effects, including immobility due to fluid retention and spikes in blood sugar levels reaching diabetic thresholds.

Corporate Responsibility and Investor Rights
The company's attempts to frame fluid retention as an increase in lean body mass have been criticized for obscuring significant health issues that emerged during treatment. As allegations surface concerning the unreported safety threats, Soleno Therapeutics finds itself in a precarious position regarding its accountability to investors and stakeholders.

Joseph E. Levi, Esq., representing the investors, emphasized the necessity for pharmaceutical companies to ensure transparent drug safety disclosures. The assertion that shareholders deserve accurate information before making financial commitments is at the heart of this lawsuit. With over 20 years of experience in complex securities litigation, Levi Korsinsky, LLP stands ready to pursue the case aggressively, aiming to secure substantial recoveries for affected parties.

For investors seeking involvement in this case, it is imperative to fill out preliminary forms or contact SueWallSt directly at [email protected] or call (888) SueWallSt before the lead plaintiff deadline of May 5, 2026.

In conclusion, the ongoing legal situation facing Soleno Therapeutics highlights the vital intersection of investor rights, public health implications, and the ethical obligations of pharmaceutical manufacturers. As this case develops, the outcomes could set significant precedents regarding safety data transparency in the pharmaceutical industry.