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Enliven Therapeutics, Inc. (ELVN) filed an 8-K current report with the SEC on June 11, 2026 reporting Item 7.01 (Regulation FD Disclosure), Item 8.01 (Other Events), Item EX-99.1 (Exhibit EX-99.1). Updated positive Phase 1 ENABLE data for ELVN-001 in chronic myeloid leukemia.
Enliven Therapeutics, Inc. 8-K event analysis
AI summary of each reported item and its exhibits
Item 7.01 · Regulation FD Disclosure
- Updated positive Phase 1 ENABLE data for ELVN-001 in chronic myeloid leukemia
- Data announcement dated June 11, 2026, with full results in Exhibit 99.1
- Early clinical readout potentially relevant to ELVN-001 development and investor expectations
Item 8.01 · Other Events
- Phase 1 ENABLE enrolled 161 heavily pretreated CML patients; 70% had received at least three prior TKIs
- ELVN-001 achieved 40% MMR in Phase 1b and 48% at the selected 80 mg QD dose by 24 weeks
- DMR reached 22% overall and 30% in the 80 mg QD cohort, supporting advancement into Phase 3
- FDA meeting endorsed 80 mg QD for ENABLE-2, a randomized trial versus physician’s choice of an ATP-competitive TKI
- Safety remained a consideration: Grade ≥3 adverse events occurred in 24% at 80 mg QD, while 6% discontinued for adverse events
Item EX-99.1 · Exhibit EX-99.1
- Phase 1b efficacy: 61% overall MMR and 48% achieved MMR by 24 weeks at 80 mg QD
- Broader Phase 1b achieved MMR: 67% among patients with 1–2 prior TKIs
- FDA alignment supports 80 mg QD and at least one prior TKI population for pivotal ENABLE-2
- ENABLE-2 Phase 3 expected to begin in the second half of 2026, with final design details pending
- Safety remains a key watchpoint: 34% Grade ≥3 TEAEs overall and 6% discontinued due to adverse events
Generated from the filing text and exhibits; verify against the original. What 8-K item codes mean
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