Short answer
Olema Pharmaceuticals, Inc. (OLMA) filed an 8-K current report with the SEC on May 21, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events). Preliminary Phase 1 data for OP-3136, an investigational KAT6 inhibitor, introduces an early clinical catalyst for Olema.
Olema Pharmaceuticals, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Preliminary Phase 1 data for OP-3136, an investigational KAT6 inhibitor, introduces an early clinical catalyst for Olema
- Data timing: May 21, 2026, with full results in Exhibit 99.1
- Investor focus: safety, tolerability, pharmacokinetics, and preliminary efficacy signals could shape further development
- Disclosure furnished under Regulation FD, limiting Exchange Act Section 18 liability absent explicit incorporation
Item 8.01 · Other Events
- OP-3136 Phase 1 data supports continued development in heavily pretreated ER+/HER2- cancers and other advanced solid tumors
- No dose-limiting toxicities through 45 mg daily, with no treatment discontinuations from treatment-related adverse events
- Tumor shrinkage in 13 of 19 response-evaluable patients, including 2 confirmed partial responses
- Dysgeusia affected 81% and neutropenia 34% of patients, including 28% with grade 3 neutropenia
- Target engagement and exposure supported dose selection, with efficacy-target concentrations achieved at doses of 6 mg and above
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