Celcuity to start Phase 1b/2 trial of gedatolisib + darolutamide in mCRPC; Bayer supplies drug free

Celcuity Inc.

FDA cleared IND for gedatolisib in combination with darolutamide; trial to begin Q1 2024.
Phase 1b/2 study CELC-G-201 will enroll up to 54 mCRPC patients who progressed after first-line AR inhibitor.
Bayer will provide Nubeqa (darolutamide) at no cost under clinical trial collaboration and supply agreement.
Virtual Science Day scheduled for September 21, 2023 (10:00 a.m. – 12:00 p.m. ET) with key opinion leaders.

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