#United States #New York #Class Action #Soleno Therapeutics #DCCR

Soleno Therapeutics and the Alleged Securities Fraud

In an alarming development for investors, Soleno Therapeutics, Inc. (NASDAQ: SLNO) is under scrutiny following allegations of securities fraud related to its DCCR (diazoxide choline extended-release tablets) product. SueWallSt has encouraged investors who faced financial losses between March 26, 2025, and November 4, 2025, to explore their options for participating in a potential class action lawsuit.

The primary issue stems from the FDA's approval of Soleno’s DCCR for the treatment of hyperphagia in those with Prader-Willi syndrome—an approval granted on March 26, 2025. Shortly after this approval, Soleno's executives reportedly made numerous public statements assuring the drug’s safety and effectiveness, ultimately suggesting strong commercial potential. However, a class action lawsuit alleges that these statements misrepresented or concealed serious safety risks associated with the drug's use, including significant adverse events such as fluid retention, pre-diabetes, and potential heart failure.

Timeline of Key Events

• - March 26, 2025: FDA approves VYKAT XR, Soleno’s sole commercial product. During a conference call, the company touted a well-established safety profile and claimed no contraindications for diabetes, omitting critical data indicating risks observed during clinical trials.
• - May 7, 2025: Soleno announced its first-quarter earnings, maintaining that the interest in DCCR was exceptionally high and that the company was ideally positioned for sustained growth. However, these statements purportedly repeated incomplete safety assertions that misled investors.
• - June 10, 2025: During a Goldman Sachs Global Healthcare Conference, the CFO claimed only two severe adverse events from the entire clinical program, downplaying the reported risks, some of which, according to insiders, were more alarming than publicly admitted.
• - August 6, 2025: The second-quarter results were disclosed, with reported revenues of $32.7 million. Management claimed no new safety signals had emerged, further contributing to the alleged pattern of concealment.
• - August 15, 2025: A significant turning point occurred when Scorpion Capital released a comprehensive report highlighting various safety concerns and the questionable integrity of clinical trial data supporting DCCR. This report also captured testimony from clinical trial investigators who voiced widespread skepticism regarding the drug's safety profile.

Joseph E. Levi, Esq., a representative of those looking to lead the class action, emphasized the importance of timely and accurate information as essential for maintaining fair markets. He noted, "Timely disclosure of material developments is fundamental to fair and efficient markets. The chronology in this case raises questions about whether investors received accurate safety information at each critical juncture."

What Investors Should Do

Investors who acquired Soleno securities between the specified dates may be eligible to recover their losses. The deadline to apply as a lead plaintiff in the class action is May 5, 2026. Affected individuals are advised to reach out to legal counsel for guidance and assistance with the potential claims.

In summary, as Soleno Therapeutics faces serious allegations of misleading its investors regarding the safety and efficacy of DCCR, the situation is a reminder of the vital importance of transparency in the pharmaceutical industry. The outcome of the class action could set a precedent for accountability standards going forward within the sector.