Core Insights - Enliven Therapeutics announced positive initial data from the Phase 1b ENABLE clinical trial for ELVN-001, showing a cumulative major molecular response (MMR) rate of 69% by 24 weeks, with 53% of patients achieving MMR [1][2] - ELVN-001 is positioned as a potentially best-in-class active-site TKI for chronic myeloid leukemia (CML), demonstrating a favorable safety and tolerability profile across all evaluated doses [1][3][11] - The company anticipates multiple key data, regulatory, and operational catalysts in 2026, including the initiation of a Phase 3 trial [1][2][11] Clinical Data Summary - In the Phase 1b trial, 60 patients were enrolled, with 53% having received four or more prior TKIs, indicating a heavily pretreated population [5][6] - The 80 mg QD cohort (n=19) showed an MMR achievement rate of 38% and a deep molecular response (DMR) rate of 16% [5][6] - The randomized 60 mg and 120 mg cohorts (n=41) demonstrated higher rates of MMR achievement at 53% and DMR at 35% [5][6] ELVN-001 Program Updates - ELVN-001 is designed to specifically target the BCR::ABL gene fusion, the oncogenic driver in CML, and has shown activity against the T315I mutation, which is resistant to most approved TKIs [3][8] - The ENABLE trial is a dose escalation and expansion study aimed at evaluating the safety, tolerability, and recommended dose for further clinical evaluation [7] Future Milestones - The company plans to present additional Phase 1 data mid-year 2026 and is preparing for regulatory interactions with the FDA regarding dose selection and Phase 3 trial design [11] - The initiation of ENABLE-2, the Phase 3 clinical trial of ELVN-001, is expected in the second half of 2026 [11]

Core Insights - Enliven Therapeutics has appointed Scott Garland to its Board of Directors as it transitions to late-stage development and commercialization of its drug ELVN-001, while Andrew Phillips, Ph.D., has resigned from the board [1][3] Leadership Changes - Scott Garland brings over 30 years of commercial leadership experience in the pharmaceutical industry, having held significant roles in companies such as PACT Pharma, Portola Pharmaceuticals, Relypsa, Exelixis, Genentech, Amgen, and Merck [2] - Rick Fair, CEO of Enliven, emphasized Garland's experience in oncology and hematology commercialization as crucial for advancing ELVN-001 into a pivotal Phase 3 trial [2] - Andrew Phillips expressed pride in the progress made during his tenure and acknowledged the need for board evolution as the company moves towards late-stage development [3] Clinical Development Focus - Following positive clinical data for ELVN-001 reported in 2025, Enliven is preparing to initiate a Phase 3 pivotal trial in 2026, aiming for potential commercialization [1][3] - The leadership changes, including the appointment of Rick Fair as CEO and Scott Garland to the board, reflect Enliven's commitment to aligning experienced governance with its transition into late-stage development [3] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving survival and overall well-being through precision oncology [5]

Core Insights - Enliven Therapeutics has appointed Rick Fair as the new Chief Executive Officer, effective December 11, 2025, while co-founder Sam Kintz transitions to Head of Pipeline [1][2][4] - The leadership change is aimed at advancing the company's pivotal Phase 3 trial for ELVN-001 in chronic myeloid leukemia (CML) and enhancing the focus on early pipeline assets [1][4] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics to improve patient outcomes and address unmet medical needs [5][6] - The company employs a precision oncology approach, leveraging insights into biological targets and differentiated chemistry to create potentially first-in-class or best-in-class therapies [6] Leadership Experience - Rick Fair brings over 25 years of experience in product development and commercialization, including significant roles at Bellicum Pharmaceuticals and Roche/Genentech, where he led the Global Product Strategy for Oncology/Hematology [3] - Fair's expertise includes overseeing the launch of five new therapies and managing a $23 billion business portfolio during his tenure at Roche/Genentech [3] Strategic Focus - The transition in leadership is designed to enhance Enliven's ability to execute a successful Phase 3 trial for ELVN-001, which is expected to begin in 2026 [2][4] - The company aims to deliver long-term value to shareholders through the commercialization of ELVN-001, which is positioned as a potential best-in-class treatment for CML [4]

Core Insights - Enliven Therapeutics, Inc. announced the presentation of data from its ENABLE Phase 1a/1b clinical trial of ELVN-001 at the Society of Hematologic Oncology (SOHO) 2025 Annual Meeting [1] - The presentation will include both an oral and a poster session, showcasing the company's focus on chronic myeloid leukemia treatment [2] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company dedicated to the discovery and development of small molecule therapeutics aimed at improving patient survival and overall well-being [3] - The company employs a precision oncology approach to address unmet medical needs, leveraging insights into clinically validated biological targets and innovative chemistry [3]

Core Insights - Enliven Therapeutics announced positive Phase 1 clinical trial data for ELVN-001 in chronic myeloid leukemia (CML), with a cumulative major molecular response (MMR) rate of 47% and 32% of patients achieving MMR by 24 weeks, alongside a favorable safety profile [1][2][7] - The company has a strong financial position with $491 million in cash and equivalents, expected to sustain operations into the first half of 2029 [1][2][7] Pipeline Updates - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion, which is crucial for CML patients [3] - The company plans to initiate a Phase 3 pivotal trial for ELVN-001 in 2026, building on the positive findings from the Phase 1 trial [2][7] Financial Results - For Q2 2025, Enliven reported R&D expenses of $21.5 million, up from $18.8 million in Q2 2024, and G&A expenses of $7.1 million, compared to $5.8 million in the same period last year [7][11] - The net loss for Q2 2025 was $25.3 million, compared to a net loss of $20.0 million in Q2 2024 [7][11] Balance Sheet Highlights - As of June 30, 2025, the company had total current assets of $495.6 million, including cash, cash equivalents, and marketable securities of $490.5 million [12] - Stockholders' equity stood at $488.5 million, reflecting a significant increase from $309.8 million at the end of 2024 [12]

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial for ELVN-001, a treatment for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 47% and an achieved MMR rate of 32% by 24 weeks [1][11] - The trial demonstrated a favorable safety and tolerability profile, with only 3.4% of patients experiencing dose reductions due to treatment-emergent adverse events (TEAEs) and 4.6% discontinuing treatment due to TEAEs [11] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics aimed at improving the quality of life and survival for patients [13] - The company is based in Boulder, Colorado, and aims to address unmet needs in precision oncology [13] Clinical Trial Details - The ENABLE trial is a Phase 1 study evaluating ELVN-001 in previously treated CML patients, with a focus on safety, tolerability, and determining the recommended dose for further evaluation [9] - As of April 28, 2025, 90 patients were enrolled, with a median treatment duration of approximately 29 weeks [5] Efficacy Data - Among 53 evaluable patients, 25 (47%) achieved MMR by 24 weeks, with 13 of 41 (32%) achieving and 12 of 12 (100%) maintaining MMR [5][11] - The trial included heavily pretreated patients, with 67% having received three or more prior TKIs [5] Safety Profile - ELVN-001 was well tolerated across all evaluated doses, with low levels of dose reductions and discontinuations [11] - The maximum tolerated dose was not reached, and the pharmacokinetic profile supports once-daily dosing [11][12] Future Outlook - Enliven plans to initiate a head-to-head Phase 3 pivotal trial for ELVN-001 in 2026, leveraging insights from historical Phase 1 data to guide regulatory pathways [7][9]

Core Insights - Enliven Therapeutics announced positive data from the Phase 1 ENABLE clinical trial of ELVN-001 for chronic myeloid leukemia (CML), showing a cumulative major molecular response (MMR) rate of 44% by 24 weeks [1][5] - The trial included 74 patients with a median treatment duration of approximately 26 weeks, demonstrating a favorable safety and tolerability profile [1][5] - The updated data will be presented at the European Hematology Association (EHA) Congress in June 2025, with a webcast and conference call scheduled for the same day [1][7] Company Overview - Enliven Therapeutics is a clinical-stage biopharmaceutical company focused on developing small molecule therapeutics, particularly for oncology [10] - The company aims to address unmet medical needs through a precision oncology approach, enhancing patient survival and well-being [10] Product Details - ELVN-001 is a selective small molecule kinase inhibitor targeting the BCR::ABL gene fusion, which is the oncogenic driver in CML [2][9] - The ongoing ENABLE trial is designed to evaluate the safety, tolerability, and recommended dose of ELVN-001 in patients who have failed or are intolerant to existing therapies [8] Clinical Trial Insights - As of January 21, 2025, 74 patients were enrolled in the ENABLE trial, with 66% having received three or more prior tyrosine kinase inhibitors [5] - Among evaluable patients, 44% achieved MMR by 24 weeks, with 100% of those maintaining MMR at the data cutoff [5] - The trial's results are favorable compared to previous Phase 1 trials of approved BCR::ABL1 TKIs, particularly given the heavily pretreated patient population [5] Upcoming Events - The oral presentation at the EHA Congress will be led by Dr. Andreas Hochhaus, focusing on the ENABLE trial results [6] - Following the presentation, additional data will be available on the company's website [6]