A securities class action lawsuit under the Securities Exchange Act of 1934 has been filed against Soleno Therapeutics, Inc. (NASDAQ: SLNO) and certain of its executives for the period between March 26, 2025 and November 4, 2025. Investors allege that the company and its officers made materially false and misleading statements regarding the safety profile and commercial viability of VYKAT XR (DCCR), the company's only commercial product used to treat hyperphagia in patients with Prader-Willi syndrome.
According to the complaint, while executives touted a favorable safety profile with no new safety signals and strong commercial adoption, the company had allegedly concealed significant safety concerns including risks of excess fluid retention, pre-diabetes, diabetes, pulmonary edema, and congestive heart failure. As these safety issues emerged publicly through an investigative report, a patient death, and management admissions of commercial disruption, Soleno Therapeutics, Inc.'s stock price moved from over $90 per share to lows of less than $45 per share, reflecting a pattern of material stock price declines.
“Most SLNO shareholders never file or join the class action, which means they miss out on potential recovery funds,” said Attorney Joseph Levi.
Case Name: City of Pontiac Police and Fire Retirement System v. Soleno Therapeutics, Inc., et al.
Case No.: 3:26-cv-01979
Jurisdiction: U.S. District Court, Northern District of California, San Francisco Division
Filed on: March 6, 2026
Soleno Therapeutics (NASDAQ: SLNO), a rare disease focused biopharmaceutical company, is a pharmaceutical company focused on developing therapies for rare diseases and is headquartered in Redwood City, California. At the time of the complaint filing, the company's only commercial product, reflecting its single-product company dependency, was diazoxide choline extended-release tablets (DCCR), marketed as VYKAT XR, for the treatment of hyperphagia in individuals with Prader-Willi syndrome, including hyperphagia in PWS.
March 26, 2025 – November 4, 2025, inclusive.
All persons who purchased Soleno Therapeutics, Inc. common stock during the Class Period may be eligible to join the Soleno Therapeutics, Inc. (SLNO) class action lawsuit, including investors who purchased common stock on the NASDAQ (NASDAQ: SLNO).

The complaint targets Soleno Therapeutics, Inc. and three of its executives: Anish Bhatnagar, Chief Executive Officer and Chairman of the Board; James Mackaness, Chief Financial Officer; and Meredith Manning, Chief Commercial Officer, alleging violations of the Securities Exchange Act of 1934. Investors allege that these defendants made materially false and misleading statements about the safety profile and commercial prospects of VYKAT XR throughout the class period and downplayed or concealed material safety concerns and related commercial risks.
On March 26, 2025, as the product received approval, by the Food and Drug Administration, CEO Bhatnagar emphasized on a conference call that the label "reflects VYKAT's favorable safety and tolerability profile, contains no [box] warnings, no contraindications for diabetes, no exclusions for severity of hyperphagia, and no requirement for a risk evaluation and mitigation strategy or REMS program."
Just weeks later on May 7, 2025, Bhatnagar highlighted in a press release that "the high level of interest that we are experiencing, as reflected in both patient start forms and unique prescribers, reflects the significant unmet need that VYKAT XR can address as a first-to-market treatment for this debilitating condition." During the second quarter, Soleno Therapeutics, Inc. reported $32.7 million in revenue from DCCR sales, and by August 6, 2025, Bhatnagar told investors on a conference call that "discontinu
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