Skye Bioscience, Inc.
For the period ended Mar 10, 2026. Filed Mar 10, 2026.
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Mar 10, 2026 · Filed Mar 10, 2026
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EX-99.1 · Phase 2b (CBeyond 2): Regulatory Alignment and Protocol Finalization
Phase 2b (CBeyond 2): Regulatory Alignment and Protocol Finalization
Completed an FDA Type C meeting and received written minutes. As Skye continues its review of the written feedback, the Company is using the minutes to sharpen its ongoing Phase 2b evaluation across key design elements (including dose, duration, endpoints and inclusion/exclusion criteria) and to assess the data package needed for potential combination development with an incretin therapy.
Skye is evaluating a Phase 2b protocol that could study multiple doses of nimacimab as a monotherapy and in combination with an incretin therapy, using an adaptive design framework. Skye is continuing Phase 2b protocol development for the study.
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