secwatch.observer — SEC 8-K summary
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Issuer:     Olema Pharmaceuticals, Inc. (OLMA)
CIK:        0001750284
Form:       8-K
Filed at:   2024-12-10T23:59:59+00:00
Accession:  0000950170-24-134759
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Olema gets FDA IND clearance for OP-3136; palazestrant combo shows 73% 6-month PFS
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- FDA cleared IND for KAT6 inhibitor OP-3136; Phase 1 to start early 2025.
- Phase 1b/2 palazestrant + ribociclib: median PFS not reached at 12-month follow-up.
- 6-month PFS rate 73% overall, 81% in ESR1 mutant patients, 68% after prior CDK4/6i.
- ORR 27% (10/37) in measurable disease; 76% CBR overall.
- Combination well tolerated with no new safety signals; plans for Phase 3 OPERA-02 in 2025.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1750284/000095017024134759/0000950170-24-134759-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1750284/000095017024134759/olma-20241209.htm
  HTML page:      https://secwatch.observer/filing/0000950170-24-134759

License: Source filings: public domain (SEC EDGAR). Summaries (headline + bullets): CC-BY-4.0; attribute https://secwatch.observer