According to the lawsuit, defendants made false and/or misleading statements and/or failed to disclose that:
- the Soleno Phase 3 clinical trial program for diazoxide choline extended-release tablets (“DCCR”) had systematically downplayed, misrepresented, and/or concealed significant evidence of safety concerns potentially related to the administration of DCCR, including issues related to excess fluid retention in clinical trial participants;
- as a result, the administration of DCCR to treat hyperphagia in individuals with Prader-Willi syndrome (“PWS”) posed materially greater safety risks than disclosed by Soleno or its executives; and
- as a result, 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.
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