Archived Investigations
Soleno Therapeutics, Inc. (NasdaqCM: SLNO)
According to the Complaint, Soleno and certain of its executives are charged with failing to disclose material information during the Class Period, violating federal securities laws.
The alleged false and misleading statements and/or omissions include, but are not limited to, that: (i) The Phase 3 clinical trial program for DCCR, the Company’s only commercial product (for the treatment of hyperphagia in individuals afflicted with Prader-Willi syndrome or “PWS”), systematically minimized, mischaracterized, and/or failed to disclose substantial evidence of potential safety concerns associated with its administration, including indications of excessive fluid retention among clinical trial participants; (ii) as a result, the administration of DCCR to treat hyperphagia in individuals with PWS posed materially greater safety risks than disclosed by the Company; and (iii) consequently, DCCR had materially lower commercial viability and undisclosed risks related to the likelihood of significant and widespread adverse events after its commercial launch, including risks related to patient discontinuation rates, lower patient adoption, prescriber reluctance, adverse regulatory action, and potential reputational and legal fallout.
The case is City of Pontiac Police and Fire Retirement System v. Soleno Therapeutics, Inc., No. 26-cv-01979.