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]

NEW YORK, March 16, 2026 (GLOBE NEWSWIRE) -- Levi & Korsinsky, LLP notifies investors in Soleno Therapeutics, Inc. (NASDAQ: SLNO) that a class action lawsuit has been filed on behalf of shareholders who purchased securities between March 26, 2025 and November 4, 2025. Find out if you qualify to recover losses. You may also contact Joseph E. Levi, Esq. at jlevi@levikorsinsky.com or (212) 363-7500. The lawsuit contends that Soleno's Phase 3 clinical trial program for DCCR (marketed as VYKAT XR) systematically ...

SLNO Lawsuit Alleges Allegedly Conducting Sham Clinical Trials - Soleno Therapeutics, Inc. Investors Face Losses Following Allegedly Conducting Sham Clinical Trials: SueWallSt Accessibility Statement Skip NavigationAlert: Claims Focus on Alleged Misrepresentations About Clinical Trial Integrity and Drug SafetyNEW YORK, March 12, 2026 /PRNewswire/ -- Levi & Korsinsky, LLP reminds purchasers of Soleno Therapeutics, Inc. (NASDAQ: SLNO) securities of a pending securities class action.THE CASE: A class action se ...