Rinzimetostat (ORIC-944) - (Himalayas-1)

July 14, 2026: ORIC Pharmaceuticals, Inc. (NASDAQ: ORIC) announced initiation of the Himalayas-1 global Phase 3 registrational trial evaluating rinzimetostat (EED/PRC2 allosteric inhibitor) in combination with darolutamide in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone. Following end-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the protocol and selected rinzimetostat 400 mg once daily as the Phase 3 recommended dose.

Himalayas-1 is expected to enroll ~600 patients across >250 sites in 25 countries, randomized 1:1 to rinzimetostat + darolutamide versus physician’s choice of an androgen receptor inhibitor or docetaxel. Primary endpoint is radiographic progression-free survival; key secondary endpoint is overall survival; other secondary endpoints include PSA response rate, objective response rate, and patient-reported outcomes.

ORIC also entered a clinical trial collaboration and supply agreement with Bayer under which ORIC sponsors/conducts the trial and Bayer provides NUBEQA (darolutamide) at no cost for use in the study; Bayer receives no license or rights to rinzimetostat, and ORIC retains global development and commercial rights.