#United States #New York #VYKAT XR #Soleno Therapeutics #DCCR

Investor Alert: Soleno Therapeutics, Inc.

Soleno Therapeutics, Inc. (NASDAQ: SLNO) is currently under scrutiny as a securities fraud lawsuit unfolds. This lawsuit encourages investors who have faced losses due to alleged misrepresentations of the company's DCCR drug safety timeline to step forward. The legal action addresses claims that Soleno provided misleading information regarding the safety of VYKAT XR, their recently FDA-approved product.

Background on DCCR and VYKAT XR

On March 26, 2025, VYKAT XR, a medication designed to treat hyperphagia in individuals suffering from Prader-Willi syndrome, received FDA approval. The approval was heralded by Soleno as an indication of a well-established safety profile, backed by over four years of clinical data. The excitement around this announcement was palpable, with the company showcasing no significant safety warnings or contraindications on the product label.

However, the lawsuit reveals that this portrayal may have omitted critical data associated with serious risks such as fluid retention, pre-diabetes, and potential heart failure. As investors who purchased SLNO securities between March 26, 2025, and November 4, 2025, navigated through Soleno’s public assertions, several statements were issued which raised alarming concerns about the actual safety of the drug, which they claim were strategically downplayed by the company’s executives.

Sequence of Key Events and Allegations

1. FDA Approval and Safety Assurances (March 26, 2025): Following the drug's approval, Soleno publicized their confidence in VYKAT XR's safety. A conference call by executives emphasized its beneficial safety profile while omitting the risks identified during clinical trials.

2. Positive First Quarter Results (May 7, 2025): Soleno reported significant revenue and momentum, claiming a high interest in VYKAT XR and suggesting its strong market positioning. These communications again minimized serious safety concerns by emphasizing incomplete safety assurances.

3. Goldman Sachs Conference (June 10, 2025): At a high-profile investor conference, Soleno's CFO minimized the reported adverse events associated with the drug, claiming that side effects were mild and self-limiting. The complaint stated that the risk information presented was significantly less alarming than documented in scientific analyses.

4. Second Quarter Results (August 6, 2025): Reports indicated higher DCCR revenues coupled with declarations of no new safety signals. This assertion further illuminated the alleged pattern of misrepresentation regarding post-marketing safety signals.

5. Scorpion Capital Report (August 15, 2025): An extensive report published by Scorpion Capital examined whether the drug's risks were accurately communicated. Citing interviews with trial investigators, the report suggested several adverse reactions, leading to moral and ethical concerns over VYKAT XR's safety data.

Investor Concerns

In light of these revelations, the lawsuit contends that the chronicle of misleading statements created a false narrative about the safety and benefits of VYKAT XR, prompting investors to rely on unsubstantiated assurances provided by Soleno executives. By failing to disclose critical safety information, Soleno may have compromised the integrity of the financial market, leaving many investors facing significant losses.

Next Steps for Investors

Affected investors are urged to submit their claims before the deadline of May 5, 2026. Those interested in potentially leading the class action suit or seeking consultation can contact the law firm Levi Korsinsky, which has a long-standing reputation for representing shareholders in similar securities class actions. Interested parties can reach out via email or phone to learn about their eligibility and the processes involved in asserting their claims against Soleno Therapeutics.

The filing of this lawsuit marks a critical moment for accountability in the pharmaceutical industry amidst rising investor protection advocacy. Stakeholders are advised to keep close tabs on this case and engage with legal experts to safeguard their investments and seek restitution if they fall within the impacted investor group.