Welcome to our dedicated page for Enliven Therapeutics news (Ticker: ELVN), a resource for investors and traders seeking the latest updates and insights on Enliven Therapeutics stock.
Enliven Therapeutics reports clinical-stage biopharmaceutical developments for a small-molecule oncology pipeline led by ELVN-001, a kinase inhibitor designed to target the BCR::ABL gene fusion in chronic myeloid leukemia. News commonly covers ENABLE clinical-trial updates, CML data presentations, regulatory-development topics, quarterly financial results, and preparation for later-stage development.
Company updates also include leadership and board changes, Nasdaq inducement grants, investor-conference participation, and descriptions of Enliven's precision oncology discovery process built around clinically validated biological targets and differentiated chemistry.
Enliven Therapeutics (Nasdaq: ELVN) said company management will present in a fireside chat at the TD Cowen 46th Annual Health Care Conference on March 3, 2026 at 10:30 a.m. ET. The event will be webcast live and archived for 90 days on the investor relations site.
Enliven (Nasdaq: ELVN) reported initial Phase 1b ENABLE data for ELVN-001 in relapsed, refractory or intolerant CML as of Dec 22, 2025. Across 60 enrolled patients, cumulative MMR reached 69% by 24 weeks in the randomized 60/120 mg cohorts and 47% in the 80 mg cohort; achieved MMR was 53% (60/120 mg) and 38% (80 mg). Deep molecular response was 35% in 60/120 mg versus 16% in 80 mg. Safety was described as favorable with no maximum tolerated dose or new safety signals. Company plans regulatory alignment with FDA on dose and to initiate the Phase 3 ENABLE-2 trial in the second half of 2026, with a mid-year Phase 1 data presentation expected.
Enliven Therapeutics (Nasdaq: ELVN) announced board and leadership changes as it prepares to advance ELVN-001 into a pivotal Phase 3 trial in 2026 following positive clinical data in 2025. Effective January 7, 2026, Scott Garland, a commercial biopharma executive with more than 30 years of experience, joins the Board and Andrew Phillips, Ph.D., will resign from the Board. The company also noted the December appointment of Rick Fair as CEO.
Management and board changes are presented as alignment for late-stage development and potential commercialization of ELVN-001 for chronic myeloid leukemia.
Enliven Therapeutics (Nasdaq: ELVN) announced on December 11, 2025 an inducement stock option grant tied to the start of Richard Fair's employment as President and Chief Executive Officer.
The company granted an option to purchase 875,000 shares at an exercise price of $18.77 per share (equal to the closing price on the grant date). Vesting is 25% after one year (December 11, 2026) and then 1/48th monthly thereafter, subject to continued service. The award is under the 2025 Inducement Equity Incentive Plan and was granted pursuant to Nasdaq Listing Rule 5635(c)(4).
Enliven Therapeutics (Nasdaq: ELVN) announced Rick Fair as Chief Executive Officer and board member, effective December 11, 2025, while co-founder Sam Kintz moves to Head of Pipeline. The leadership change is positioned to support a planned pivotal Phase 3 trial of ELVN-001 in chronic myeloid leukemia (CML), targeted to start in 2026, and future commercialization.
Mr. Fair brings 25+ years of product development and commercialization experience, including leadership roles at Bellicum, Roche/Genentech and Johnson & Johnson, and oversight of launches and commercialization planning for a $23 billion portfolio. Sam Kintz will focus on advancing early pipeline assets toward the clinic.
Enliven Therapeutics (Nasdaq: ELVN) reported Q3 2025 results and a clinical update on ELVN-001 in chronic myeloid leukemia (CML). The company completed enrollment of the randomized Phase 1b cohorts of the ENABLE trial (NCT05304377) and remains on track to initiate a Phase 3 pivotal trial in 2026. Cash, cash equivalents and marketable securities were $477.6 million as of September 30, 2025, which management expects will fund operations into the first half of 2029.
Q3 operating items: R&D $18.2M, G&A $6.9M, and net loss $20.1M.
Enliven Therapeutics (Nasdaq: ELVN) reported Q3 2025 results and a clinical update on Nov 12, 2025. Key highlights: completed dosing in the randomized Phase 1b cohorts of the ENABLE trial for ELVN-001 in CML and remains on track to initiate a global Phase 3 pivotal trial in 2026. Management presented ENABLE data at multiple international meetings and will present additional subset data at ASH 2025 on Dec 7, 2025. Financials: cash, cash equivalents and marketable securities of $477.6M, expected to provide runway into the first half of 2029. Q3 operating figures: R&D $18.2M, G&A $6.9M, net loss $20.1M.
Enliven Therapeutics (Nasdaq: ELVN) will present preliminary Phase 1a/1b ENABLE data on ELVN-001 in chronic myeloid leukemia patients with atypical BCR::ABL1 fusion transcripts at ASH 2025 (Dec 6-9).
As of Apr 28, 2025 six previously treated chronic phase CML patients with atypical transcripts received ELVN-001 (20–80 mg BID; some escalated to 120 mg QD). Four patients were efficacy-evaluable and showed transcript reductions including multiple >1 log decreases, a fall from 0.95% to 0.15%, and durable on-study durations (80–505 days). No treatment-emergent adverse events >Grade 2 were reported in these patients. Presentation details: poster session Dec 7, 6:00–8:00 p.m. ET.
Enliven Therapeutics (Nasdaq: ELVN) announced upcoming presentations of data from its ENABLE Phase 1a/1b clinical trial of ELVN-001 at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting. The trial focuses on ELVN-001, a selective active site inhibitor of BCR::ABL1, in patients with previously treated Chronic Myeloid Leukemia.
The data will be presented in both oral and poster formats by Dr. Michael J. Mauro on September 3-4, 2025, at the George R. Brown Convention Center in Houston. This presentation is an encore of previously presented data at the European Hematology Association (EHA) 2025 Congress.
Enliven Therapeutics (Nasdaq: ELVN) reported significant progress in Q2 2025, highlighted by positive Phase 1 clinical trial results for ELVN-001 in chronic myeloid leukemia (CML) treatment. The trial demonstrated a 47% cumulative MMR rate, with 32% of patients achieving MMR by 24 weeks, surpassing historical data from competitor treatments.
The company strengthened its financial position through a $230 million public offering, ending Q2 with $490.5 million in cash and equivalents, extending runway into H1 2029. Quarterly financials showed R&D expenses of $21.5 million and a net loss of $25.3 million. Enliven plans to initiate a Phase 3 pivotal trial in 2026.