Skye Bioscience outlines 2026 clinical milestones for obesity drug

Skye Bioscience Inc. (NASDAQ: SKYE) outlined its 2026 corporate development plan for nimacimab, its experimental obesity treatment, according to a company statement.

The clinical-stage biotechnology company expects to report CBeyond Phase 2a 26-week extension data and interim results in the first quarter of 2026. The company plans to release topline results for the full 52-week study period, including a 13-week off-therapy follow-up, in the third quarter of 2026.

A Data Monitoring Committee meeting on December 14, 2025, continued to show a favorable safety profile for the drug candidate, the company stated. Skye plans to finalize its Phase 2b trial design in the first quarter and launch the study in the third quarter of 2026.

Nimacimab is designed as a peripherally-restricted monoclonal antibody that inhibits the CB1 receptor. The drug aims to avoid central nervous system penetration to limit neuropsychiatric side effects associated with previous CB1-targeting treatments.

Previous Phase 2a data showed additional weight loss when nimacimab was combined with semaglutide compared to semaglutide alone, with no plateau observed at 26 weeks. The combination also demonstrated reductions in waist circumference and improved lean-to-fat mass ratio.

The company established partnerships in 2025 to support higher-dose delivery, including an agreement with Arecor Therapeutics to develop a higher concentration formulation and licensing Halozyme Therapeutics' ENHANZE drug delivery technology for subcutaneous administration.

"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," said Punit Dhillon, President and Chief Executive Officer.

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