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Get filing alertsOlema announces clinical trial collaboration with Bayer for OP-3136 in prostate cancer
Filed May 26, 2026 · Period ending May 26, 2026 · ~1 min read
Key Changes
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Olema retains full global commercial and marketing rights to OP-3136 despite collaboration; clinical data and inventions from the combination therapy will be jointly owned with Bayer
Item 8.01 verify on EDGAR → -
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Phase 1b/2 trial will test OP-3136 (Olema's KAT6 inhibitor) combined with Bayer's NUBEQA in ~36 patients with metastatic castration-resistant prostate cancer, assessing safety and anti-tumor activity
Item 8.01 verify on EDGAR → -
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Trial expected to start in second half of 2026; Bayer will supply darolutamide while Olema leads study execution, marking first clinical collaboration for OP-3136
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Summary
Olema Pharmaceuticals announced a clinical trial collaboration with Bayer Consumer Care to evaluate its experimental cancer drug OP-3136 in combination with Bayer's approved prostate cancer treatment NUBEQA. The Phase 1b/2 study will enroll approximately 36 patients with metastatic castration-resistant prostate cancer and is expected to begin in the second half of 2026.
This represents Olema's first partnership for OP-3136, a novel KAT6 inhibitor. For investors, the key takeaway is that Olema retains full commercial rights to OP-3136 globally, even as it gains access to Bayer's established drug and expertise. The collaboration validates OP-3136's potential and provides a cost-effective path to explore combination therapy without diluting Olema's ownership of its asset.
Clinical data and inventions will be jointly owned, but commercialization control remains with Olema. Watch for trial initiation announcements in late 2026 and early safety/tolerability data readouts, which could inform OP-3136's broader development strategy and partnership value.
Section-by-Section Diff
Event · Item 7.01 — Regulation FD Disclosure
Item 7.01 — Regulation FD Disclosure filed; see Key Changes for terms.
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Olema Pharmaceuticals, Inc. (the "Company") issued a press release announcing that it had entered into a new clinical trial collaboration and supply agreement (the “Agreement”) with Bayer Consumer Care AG ("Bayer").
The company has entered into a new clinical trial collaboration and supply agreement with Bayer Consumer Care AG. This partnership will involve collaborative clinical trial activities and supply arrangements, though specific terms and scope are not detailed in the 8-K filing itself.
Event · Item 8.01 — Other Events
Item 8.01 — Other Events filed; see Key Changes for terms.
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on May 26, 2026, the Company announced that it had entered into the Agreement with Bayer. Pursuant to the Agreement, the Company and Bayer will evaluate in a Phase 1b/2 study the safety, tolerability, and preliminary anti-tumor activity of OP-3136, the Company's novel KAT6 inhibitor, in combination with NUBEQA® (darolutamide), Bayer’s androgen receptor inhibitor, in approximately 36 patients with metastatic castration-resistant prostate cancer (mCRPC).
Olema entered into a collaboration agreement with Bayer to conduct a Phase 1b/2 clinical trial combining Olema's OP-3136 (a KAT6 inhibitor) with Bayer's NUBEQA (darolutamide, an androgen receptor inhibitor) in approximately 36 patients with metastatic castration-resistant prostate cancer. The trial will assess safety, tolerability, and preliminary anti-tumor activity of the combination therapy.
Added in current filing · verify on EDGAR →
The clinical trial is expected to initiate in the second half of 2026. Bayer will supply darolutamide for use in the Phase 1b/2 study and the Company will lead the conduct of the study.
The Phase 1b/2 trial is expected to start in the second half of 2026. Bayer will provide the darolutamide drug supply while Olema will lead and manage the clinical study execution. This represents Olema's first clinical collaboration for OP-3136.
Event · Item 9.01 — Financial Statements and Exhibits
Olema Pharmaceuticals filed an 8-K attaching a press release dated May 26, 2026; no material business event disclosed in the filing body.
Show 1 minor / wording change
Added in current filing · verify on EDGAR →
Press Release, dated May 26, 2026 of Olema Pharmaceuticals, Inc.
The 8-K references an attached press release dated May 26, 2026. The filing body itself contains no substantive disclosure about the press release content, business event, or financial impact. This is a procedural filing under Item 9.01 to formally attach the exhibit.
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Figures/quotes linked to EDGAR · Narrative written by AI · May 28, 2026 · How we verify