secwatch.observer — SEC 8-K summary
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Issuer:     Enliven Therapeutics, Inc. (ELVN)
CIK:        0001672619
Form:       8-K
Filed at:   2026-06-11T12:09:27+00:00
Accession:  0001193125-26-266731
Event type: other_material
Sentiment:  positive
Materiality: 0.75
Item codes: 7.01, 8.01, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Enliven reports 61% overall MMR at 80 mg QD in Phase 1b; FDA aligns on Phase 3 design for ELVN-001
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- 161 patients enrolled; median treatment duration 35 weeks; 76% remain on study as of March 10, 2026 cutoff.
- 61% overall MMR and 48% achieved MMR by 24 weeks in the 80 mg QD Phase 1b cohort (n=28 evaluable).
- 70% of patients had 3+ prior TKIs; 62% had prior asciminib; response rates comparable regardless of prior asciminib exposure.
- Only 6% discontinued due to adverse events; Grade ≥3 TEAEs at 80 mg QD were 24% with thrombocytopenia the most common at 6%.
- FDA endorsed 80 mg QD as Phase 3 dose and 2L+ patient population; ENABLE-2 pivotal trial expected to initiate H2 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1672619/000119312526266731/0001193125-26-266731-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1672619/000119312526266731/d202685d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-26-266731

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