A securities class action has been filed against Skye Bioscience, Inc. (SKYE) on behalf of a class consisting of all persons and entities other than Defendants that purchased or otherwise acquired Skye securities between November 4, 2024 through October 3, 2025. This case has been filed in the USDC – SDCA.
Skye is a clinical stage biopharmaceutical company that focuses on developing molecules that modulate G protein-coupled receptors (“GPCRs”) to treat obesity, overweight, and metabolic diseases. The Company’s lead product candidate is nimacimab, a peripherally restricted negative allosteric modulating antibody targeting cannabinoid receptor type-1, a key GPCR involved in metabolic regulation.
In August 2024, Skye initiated its “CBeyond” clinical trial, a twenty-six-week, randomized, double-blind, placebo-controlled Phase 2a proof-of-concept study designed to assess nimacimab as a treatment for obesity and overweight. The CBeyond trial’s primary endpoint was to demonstrate an 8% difference in mean weight loss using nimacimab versus placebo at twenty-six weeks, with a thirteen-week follow-up.
At all relevant times while the Phase 2a Beyond trial was ongoing, Defendants touted nimacimab’s purported “differentiated” mechanism of action and efficacy results as purportedly demonstrated in other various studies. Critically, Defendants cited to nimacimab’s purportedly potent efficacy as observed in these various studies to suggest that the results of the Phase 2a CBeyond trial were likely to be favorable, while consistently touting nimacimab’s overall clinical, regulatory, and commercial prospects.
The complaint alleges that, throughout the Class Period, Defendants made materially false and misleading statements regarding Skye’s business, operations, and prospects. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) nimacimab was less effective than Defendants had led investors to believe; (ii) accordingly, nimacimab’s clinical, regulatory, and commercial prospects were overstated; and (iii) as a result, Defendants’ public statements were materially false and misleading at all relevant times.
On October 6, 2025, Skye issued a press release “announcing the topline data from its 26-week Phase 2a CBeyond™ proof-of-concept study of nimacimab[.]” The press release disclosed that the “the nimacimab monotherapy arm did not achieve the primary endpoint of weight loss compared to placebo” and that “preliminary pharmacokinetic analysis showed lower than expected drug exposure, potentially indicating the need for higher dosing as a monotherapy.”