Olema Pharmaceuticals, Inc. OLMA
Olema Pharmaceuticals, Inc. (Nasdaq: OLMA) is an oncology drug developer. Its lead program, Palazestrant (OP-1250), is in Phase 3 for ER+/HER2- metastatic breast cancer. Its next catalyst on record is OP-3136: Initiate combination arm with darolutamide in mCRPC (Bayer collaboration) (Q4 2026).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: OP-3136 — Initiate combination arm with darolutamide in mCRPC (Bayer collaboration) (Q4 2026). 5 catalysts on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| Palazestrant monotherapy (OPERA-01) | 2L/3L ER+/HER2- metastatic breast cancer | small molecule | Phase 3 |
| Palazestrant + ribociclib (OPERA-02) | 1L ER+/HER2- metastatic breast cancer | small molecule | Phase 3 |
| Palazestrant combinations (CDK4/6i, alpelisib, everolimus, atirmociclib) | ER+/HER2- breast cancer | small molecule | Phase 2 |
| OP-3136 (KAT6 inhibitor) | Breast cancer and other solid tumors (incl. mCRPC combination arm with darolutamide) | small molecule | Phase 1 |
Recent results and decisions
- Aug 10, 2026completed enrollment Olema completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant monotherapy.
Completed enrollment in the pivotal Phase 3 OPERA-01 trial of palazestrant as a monotherapy in patients with second or third-line estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced or metastatic breast cancer (MBC).
Filing - May 21, 2026positive OP-3136 Phase 1 monotherapy: no DLTs up to 45 mg, tumor shrinkage in 13 of 19 response-evaluable patients and 3 partial responses (2 confirmed).
Among 19 response-evaluable patients across dose levels and tumor types, tumor shrinkage was observed in 13 patients; partial responses (PR) were observed in 3 patients with measurable disease, with 2 confirmed PRs and 1 unconfirmed PR.
Filing - Mar 16, 2026started Olema initiated the Phase 1b/2 study of palazestrant with Pfizer's atirmociclib in ER+/HER2- metastatic breast cancer.
Initiated the Phase 1b/2 study evaluating palazestrant in combination with atirmociclib in estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+/HER2-) metastatic breast cancer in collaboration with Pfizer.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 oncology companies
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- BeOne Medicines Ltd. ONC
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.