Olema Pharmaceuticals Inc Dossier
Qualitative Analysis
Business overview
Olema Pharmaceuticals, Inc. (Olema Oncology) is a clinical-stage biopharmaceutical company focused on the discovery, development, and commercialization of next-generation targeted therapies for women's cancers, primarily breast cancer. The company's lead product candidate is palazestrant (OP-1250), an orally available small molecule with dual activity as both a complete estrogen receptor antagonist (CERAN) and a selective estrogen receptor degrader (SERD). Palazestrant is currently being evaluated in pivotal Phase 3 clinical trials (OPERA-01 and OPERA-02) for the treatment of estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) metastatic breast cancer. Olema's second clinical-stage candidate is OP-3136, a potent and selective oral small molecule inhibitor of KAT6, an epigenetic target dysregulated in breast and other solid tumors.
Research as of 20 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Advancing the wholly-owned lead product candidate, palazestrant (OP-1250), in the pivotal Phase 3 OPERA-01 trial as a monotherapy for patients with second- and third-line ER+/HER2- metastatic breast cancer.
Expected impact: A successful readout would support a planned NDA submission and potential commercial launch.
Evaluating palazestrant in combination with Novartis-supplied ribociclib (Kisqali) in the pivotal Phase 3 OPERA-02 trial for frontline ER+/HER2- metastatic breast cancer.
Developing OP-3136, a potent and selective oral KAT6 inhibitor, as a monotherapy and in combination regimens for breast cancer and other solid tumors.
Expected impact: Establishes a secondary clinical-stage asset targeting epigenetic dysregulation to overcome endocrine resistance.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Strategic Partnerships
Enables the evaluation of OP-3136 in combination with Bayer's NUBEQA (darolutamide) in metastatic castration-resistant prostate cancer (mCRPC), expanding Olema's pipeline beyond breast cancer.
Terms: Bayer will supply darolutamide for the Phase 1b/2 study, while Olema will lead the conduct of the trial. All clinical data and inventions related to the combination will be jointly owned, and Olema retains full global commercial and marketing rights to OP-3136.
Provides the necessary drug supply of ribociclib (Kisqali) for Olema's pivotal Phase 3 OPERA-02 trial in frontline ER+/HER2- metastatic breast cancer.
Terms: Novartis provides ribociclib drug supply for the trial. All clinical data and inventions from the trial will be jointly owned, while Olema maintains global commercial and marketing rights to palazestrant.
Evaluates the safety and combinability of palazestrant plus atirmociclib (Pfizer's investigational, highly selective CDK4 inhibitor) in patients with ER+/HER2- metastatic breast cancer.
Terms: Pfizer provides drug supply of atirmociclib for the Phase 1b/2 study.