secwatch.observer — SEC 8-K summary
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Issuer:     Enliven Therapeutics, Inc. (ELVN)
CIK:        0001672619
Form:       8-K
Filed at:   2025-06-13T23:59:59+00:00
Accession:  0001193125-25-140285
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 47% cumulative MMR by 24 weeks for ELVN-001 in Phase 1 CML trial; well-tolerated
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- 47% of evaluable patients (25/53) achieved MMR by 24 weeks; 32% (13/41) achieved MMR, comparing favorably to asciminib's 24% in Phase 1.
- 90 patients enrolled; 80% remain on study with median treatment duration ~29 weeks; heavily pretreated (67% received ≥3 prior TKIs).
- Safety: only 3.4% dose reductions, 4.6% discontinuations due to AEs; no treatment-related arterial occlusive events; no MTD reached.
- PK supports once-daily dosing with food flexibility and low drug-drug interaction potential.
- Company expects to initiate first head-to-head Phase 3 pivotal trial in 2026.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1672619/000119312525140285/0001193125-25-140285-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1672619/000119312525140285/d877944d8k.htm
  HTML page:      https://secwatch.observer/filing/0001193125-25-140285

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