ORIC® Pharmaceuticals Announces Initiation of Himalayas-1 Phase 3 Trial in mCRPC Evaluating Rinzimetostat in Combination with NUBEQA® (Darolutamide), Supported by Clinical Collaboration with Bayer
Initiated Himalayas-1 global Phase 3 trial in patients with mCRPC previously treated with abiraterone
Entered into a clinical trial collaboration and supply agreement with Bayer to provide darolutamide for Himalayas-1
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, July 14, 2026 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (NASDAQ:ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced the initiation of the Himalayas-1 global Phase 3 registrational trial in patients with metastatic castration-resistant prostate cancer (mCRPC) previously treated with abiraterone and announced a clinical trial collaboration and supply agreement with Bayer AG ("Bayer").
Himalayas-1 Global Phase 3 Registrational Trial Initiation
ORIC previously presented dose optimization data for rinzimetostat in combination with darolutamide and selected 400 mg once daily rinzimetostat as the recommended Phase 3 dose (RP3D). Following End-of-Phase 1 interactions with the FDA and other global health authorities, ORIC finalized the trial protocol and has initiated the Himalayas-1 global Phase 3 registrational trial.
The Himalayas-1 trial is expected to enroll approximately 600 patients from over 250 sites in 25 countries, randomized 1:1 to receive the RP3D of 400 mg once daily rinzimetostat (with or without food) in combination with darolutamide versus physician’s choice of an androgen receptor (AR) inhibitor or docetaxel. The primary endpoint is radiographic progression-free survival, the key secondary endpoint is overall survival, and additional secondary endpoints include PSA response rate, objective response rate and patient reported outcomes.
Clinical Trial Collaboration and Supply Agreement with Bayer
Under the terms of the agreement, ORIC will conduct and sponsor the Himalayas-1 trial and Bayer will provide their AR inhibitor, NUBEQA® (darolutamide), at no cost for use in the trial in combination with rinzimetostat. This agreement does not grant Bayer any license, option, or other rights to rinzimetostat and ORIC retains full global development and commercial rights to rinzimetostat.
"Given the significant unmet need in prostate cancer and the potential best-in-disease clinical profile that rinzimetostat has continued to demonstrate, the initiation of our Himalayas-1 Phase 3 trial represents an important milestone toward establishing rinzimetostat as a potentially practice-changing therapy for patients," said Jacob M. Chacko, M.D., president and chief executive officer. "This collaboration with Bayer strengthens our global operational readiness by securing access to darolutamide for Himalayas-1 and underscores our shared interest in evaluating this regimen for patients with prostate cancer."
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) rinzimetostat, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (2) enozertinib, a brain-penetrant inhibitor targeting EGFR exon 20 insertion and EGFR atypical mutations, being developed for NSCLC. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, expectations and plans regarding the Himalayas-1 global Phase 3 registrational trial in mCRPC evaluating rinzimetostat in combination with NUBEQA® (darolutamide); the continued clinical development of rinzimetostat; the potential advantages of rinzimetostat; clinical outcomes, which may materially change as patient enrollment continues or more patient data become available; statements regarding the potential best-in-disease profile of rinzimetostat; and statements by the company’s chief executive officer. Words such as "believes," "anticipates," "plans," "expects," "intends," "will," "goal," "potential" and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and ORIC’s limited operating history; ORIC’s ability to complete clinical trials for, obtain approvals for and commercialize rinzimetostat; delays or difficulties in the enrollment and/or maintenance of patients in the Himalayas-1 clinical trial; changes in ORIC’s plans to develop and commercialize rinzimetostat; the potential for clinical trials of rinzimetostat to differ from preclinical, initial, interim, preliminary, expected or prior clinical trial results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements or its clinical trial collaboration and supply agreements, including its agreement with Bayer; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the SEC) on May 4, 2026, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Contact:
Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com
