SKYE Stock Plunges 60% as Obesity Candidate Misses Key Phase II Goal

Core Insights - Skye Bioscience (SKYE) shares plummeted 60% after failing to meet the primary weight loss goal in a mid-stage proof-of-concept study for its only pipeline candidate, nimacimab, aimed at treating obesity [1][5] - The phase IIa CBeyond study involved 136 adults and assessed the efficacy, safety, and pharmacokinetics of nimacimab [1][3] Study Details - Patients were randomized into four groups: nimacimab 200 mg, placebo, nimacimab with Novo Nordisk's Wegovy, and placebo with Wegovy, treated weekly for 26 weeks [2] - The nimacimab 200 mg monotherapy showed a body weight reduction of 1.52% compared to 0.26% with placebo at week 26, failing to achieve the primary weight loss goal [3] - The combination of nimacimab 200 mg and Wegovy resulted in a clinically meaningful weight loss of 13.2%, compared to 10.25% with Wegovy alone, with 100% of patients in the combination group achieving over 5% weight loss [7][8] Safety and Pharmacokinetics - Preliminary pharmacokinetic analysis indicated lower than expected exposure to nimacimab, suggesting the 200 mg dose may be suboptimal [4] - The safety profile of nimacimab was favorable, with no increase in gastrointestinal adverse events or treatment-related neuropsychiatric adverse events reported [9] Future Plans - Skye Bioscience is continuing the phase IIa CBeyond study for an additional 26-week extension, with results expected in early 2026 [10][11] - The company plans to test higher doses of nimacimab based on favorable preclinical data and observed dose-dependent weight loss [12] Market Context - Novo Nordisk's Wegovy is a leading GLP-1 therapy for obesity, generating $5.41 billion in sales during the first half of 2025, a 78% increase year-over-year [13] - Wegovy has received FDA accelerated approval for treating noncirrhotic metabolic dysfunction-associated steatohepatitis, with an oral formulation under review [14]