Enliven Therapeutics, Inc. ELVN
Enliven Therapeutics, Inc. (Nasdaq: ELVN) is an oncology drug developer. Its lead program, relcobatinib (ELVN-001), is in Phase 3 for BCR-ABL-positive leukemia. Its next catalyst on record is relcobatinib (ELVN-001): ENABLE-2 Phase 3 pivotal trial initiation (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: relcobatinib (ELVN-001) — ENABLE-2 Phase 3 pivotal trial initiation (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| relcobatinib (ELVN-001) | BCR-ABL-positive leukemia | small molecule | Phase 3 |
| ELVN-002 | HER2-positive cancers | small molecule | Phase 2 |
Recent results and decisions
- Nov 5, 2026accepted Enliven reached alignment with FDA on final design of ENABLE-2 pivotal Phase 3 trial and remains on track to initiate before year-end 2026.
The Company announced that it reached alignment with the U.S. Food and Drug Administration (FDA) on the final design of the ENABLE-2 pivotal trial of relcobatinib in patients with previously treated chronic myeloid leukemia (CML).
Filing - Jun 11, 2026positive Updated Phase 1b: 61% overall MMR (48% achieved MMR by 24 weeks) in 80 mg QD cohort; 54% overall MMR in all Phase 1b (n=69); Grade>=3 TEAEs 34% overall, 6% discontinued for AEs.
Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components
Filing
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
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- Moderna, Inc. MRNA
- Revolution Medicines, Inc. RVMD
- Genmab A/S GMAB
- BioNTech SE BNTX
- Guardant Health, Inc. GH
- Exelixis, Inc. EXEL
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.