SLNO Investor Alert: Soleno Therapeutics, Inc. Securities Fraud Lawsuit - Investors With Losses May Seek to Lead the Class Action After Allegedly Conducting Sham Clinical Trials: Levi & Korsinsky

Core Viewpoint - A securities class action has been initiated against Soleno Therapeutics, Inc. due to alleged misrepresentations regarding the integrity of clinical trials and drug safety, particularly concerning its product DCCR (VYKAT XR) [1][3][6] Group 1: Lawsuit Details - The class action seeks to recover damages for investors who purchased Soleno securities between March 26, 2025, and November 4, 2025 [2] - Investors have until May 5, 2026, to seek lead plaintiff status in the lawsuit [3] Group 2: Product and Clinical Trials - DCCR is a diazoxide choline extended-release tablet aimed at treating hyperphagia in patients with Prader-Willi syndrome, with its FDA approval reliant on a pivotal Phase 3 clinical trial [3] - The pivotal study, a randomized withdrawal period of Study C602, is critical as it underpins the drug's approval and commercial viability [3] Group 3: Allegations of Clinical Trial Issues - The lawsuit claims that Soleno's Phase 3 program had systematic issues that were either known or recklessly ignored by the defendants [4] - Allegations include the downplaying of serious side effects such as fluid retention, which could lead to pulmonary edema and heart failure [4] - The complaint highlights a linear increase in prediabetes and diabetes markers over three years of treatment, raising concerns about the drug's safety profile [5] Group 4: Criticism from Medical Community - Endocrinologists and investigators have expressed skepticism regarding the drug's safety, with some indicating they would not prescribe it due to trial conduct issues [5] - The original 13-week Phase 3 trial did not meet its primary endpoint for hyperphagia improvement, and the pivotal study had a small sample size of only 77 participants, heavily skewed towards one clinical site [5] Group 5: Management's Communication - Despite the concerns raised, Soleno's management reportedly assured investors of the drug's "well-established safety profile" and claimed that "no new safety signals" had emerged post-marketing [6]