Skye's 2026 Clinical Program Focuses on Nimacimab
"In 2025 we generated our Phase 2a clinical data, deepened our understanding of nimacimab's exposure-response dynamics, and built the technical foundation required to test higher doses and prepare the framework for a potential subsequent Phase 2 trial with broader clinical endpoints," said Punit Dhillon, CEO. "In 2026, our focus and goals are straightforward: deliver additional clinical readouts from our CBeyond extension study, assess and select higher doses of nimacimab, and launch a Phase 2b study designed to evaluate multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy. We believe emerging data across the obesity treatment landscape underscore the need for modalities complementary to incretin-based therapies," added Mr. Dhillon. "We believe peripheral CB1 inhibition offers a distinctive opportunity to help achieve incremental weight loss, improve treatment tolerability and sustainability, enhance post-treatment durability, as well as offer additional metabolic and inflammatory benefits." Skye's 2026 clinical program goals are designed to evaluate multiple higher doses of nimacimab, and (nitiate a Phase 2b study that supports combination development. Planned clinical milestones include: CBeyond Phase 2a 26-week extension data update and interim results expected in Q1 2026. CBeyond Phase 2a topline results to 52 weeks including 13-week off-therapy follow-up period expected in Q3 2026. Phase 2b plan will be finalized and aligned with regulators, including completion of a Type C meeting in Q1 2026, with initiation of the adaptive design Phase 2b clinical trial expected in Q3 2026.
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Skye Bioscience to Present Nimacimab Efficacy Study at Keystone Conference
- Clinical Research Presentation: Skye Bioscience will present its study on the obesity-targeting antibody nimacimab at the Keystone conference on January 28, 2026, exploring its effects on weight loss at various doses, aiming to provide new insights for obesity treatment.
- Mechanism Exploration: The research will assess whether nimacimab can serve as a maintenance therapy after discontinuation of tirzepatide and whether its weight loss effects primarily rely on caloric restriction, thus providing crucial data support for clinical applications.
- Innovative Drug Characteristics: Nimacimab, as a peripherally-restricted monoclonal antibody, is designed to avoid central nervous system penetration, potentially reducing the neuropsychiatric side effects commonly associated with small-molecule antagonists, showcasing its unique advantages in obesity treatment.
- Clinical Trial Progress: Skye is currently conducting a Phase 2a clinical trial for nimacimab in combination with the GLP-1R agonist Wegovy®, which will provide empirical support for its market potential in the obesity sector.
Skye Bioscience Faces Class Action for Securities Fraud, Investors Encouraged to Join
- Lawsuit Reminder: The Schall Law Firm alerts investors of a class action lawsuit against Skye Bioscience for violations of securities laws, concerning securities purchases from November 4, 2024, to October 3, 2025, with a deadline to contact by January 16, 2026, to participate in claims.
- False Statements: The complaint alleges that Skye's drug candidate nimacimab was less effective than claimed, with the company overstating its commercial and clinical prospects, resulting in investor losses when the truth emerged.
- Legal Process: The class action has not yet been certified, meaning investors are not represented by an attorney until certification occurs, and those who choose not to act will remain absent class members, potentially forfeiting their claims.
- Investor Rights: The Schall Law Firm specializes in securities class actions and encourages affected investors to reach out for free consultations to discuss their rights, aiming to assist in recovering losses and protecting their legal interests.
