US Market News
18時間前
Enliven Therapeutics Announces Pricing of Upsized Public Offering of Common Stock and Pre-Funded WarrantsJune 11, 2026 10:39 PM
PR Newswire (US) BURLINGAME, Calif., June 11, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has priced its previously announced upsized underwritten public offering of 8,933,334 shares of its common stock at a price to the public of $37.50 per share and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase up to 1,733,333 shares of Enliven's common stock at a price to the public of $37.499 per pre-funded warrant, which represents the per share public offering price of each share of Enliven's common stock less the $0.001 per share exercise price for each pre-funded warrant. All of the shares and pre-funded warrants are being sold by Enliven. The gross proceeds from the offering are expected to be approximately $400.0 million before deducting underwriting discounts and commissions and other offering expenses. The offering is expected to close on or about June 15, 2026, subject to the satisfaction of customary closing conditions. In addition, Enliven has granted the underwriters a 30-day option to purchase up to an additional 1,600,000 shares of its common stock at the public offering price, less the underwriting discounts and commissions.Jefferies, Goldman Sachs & Co. LLC, Morgan Stanley and Barclays are acting as joint book-running managers for the offering. Mizuho is also acting as a book-running manager and LifeSci Capital is acting as a passive book-running manager for the offering. Baird is acting as lead manager and Jones is acting as manager for the offering.The offering is being made pursuant to a Registration Statement on Form S-3ASR, including a base prospectus, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (SEC) on August 13, 2025, and Enliven has filed with the SEC a preliminary prospectus supplement and accompanying prospectus relating to the offering. A final prospectus supplement and accompanying prospectus relating to the offering will also be filed with the SEC. These documents can be accessed for free through the SEC's website at www.sec.gov. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at prospectus@morganstanley.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (888) 603-5847, or by email at barclaysprospectus@broadridge.com.This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California.Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Enliven within the meaning of the federal securities laws, including those related to the timing of the closing of the offering and the expected gross proceeds. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: the satisfaction of customary closing conditions; prevailing market conditions; general economic and market conditions as well as geopolitical developments; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Enliven files from time to time with the Securities and Exchange Commission, including the registration statement and the preliminary prospectus supplement relating to the public offering. These forward-looking statements are made as of the date of this press release, and Enliven assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-pricing-of-upsized-public-offering-of-common-stock-and-pre-funded-warrants-302798760.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics Announces Pricing of Upsized Public Offering of Common Stock and Pre-Funded Warrants
US Market News
1日前
Enliven Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded WarrantsJune 11, 2026 4:05 PM
PR Newswire (US) BURLINGAME, Calif., June 11, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that it has commenced an underwritten public offering of $250.0 million of shares of its common stock and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase shares of Enliven's common stock. In addition, Enliven intends to grant the underwriters a 30-day option to purchase up to an additional $37.5 million of shares of its common stock. All of the shares of common stock and pre-funded warrants are being offered by Enliven. The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.Jefferies, Goldman Sachs & Co. LLC, Morgan Stanley and Barclays are acting as joint book-running managers for the proposed offering. Mizuho is also acting as a book-running manager and LifeSci Capital is acting as a passive book-running manager for the proposed offering.The offering is being made pursuant to a Registration Statement on Form S-3ASR, including a base prospectus, which became automatically effective upon filing with the U.S. Securities and Exchange Commission (SEC) on August 13, 2025, and Enliven will file a preliminary prospectus supplement and accompanying prospectus relating to and describing the terms of the offering, copies of which can be accessed for free through the SEC's website at www.sec.gov. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at (877) 821-7388, or by email at Prospectus_Department@Jefferies.com; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at Prospectus-ny@ny.email.gs.com; Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, or by email at prospectus@morganstanley.com; or Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, by telephone at (888) 603-5847, or by email at barclaysprospectus@broadridge.com.This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor will there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation, or sale would be unlawful before registration or qualification under the securities laws of any such state or jurisdiction.About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights in clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Burlingame, California.Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements about Enliven within the meaning of the federal securities laws, including those related to the completion, timing, and size of the offering and Enliven's intent to grant the underwriters a 30-day option to purchase additional shares. These forward-looking statements are neither promises nor guarantees and are subject to a variety of risks and uncertainties, including but not limited to: whether or not Enliven will be able to raise capital through the sale of securities or consummate the offering; the final terms of the offering; the satisfaction of customary closing conditions; prevailing market conditions; general economic and market conditions as well as geopolitical developments; and other risks. Information regarding the foregoing and additional risks may be found in the section entitled "Risk Factors" in documents that Enliven files from time to time with the Securities and Exchange Commission, including the registration statement and the preliminary prospectus supplement relating to the public offering. These forward-looking statements are made as of the date of this press release, and Enliven assumes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-proposed-public-offering-of-common-stock-and-pre-funded-warrants-302798527.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants
US Market News
1日前
Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design ComponentsJune 11, 2026 8:00 AM
PR Newswire (US) 61% overall MMR and 48% MMR achievement by 24 weeks in the 80 mg QD Phase 1b cohort67% overall MMR and 55% MMR achievement by 24 weeks in all Phase 1b patients who had previously received 1 or 2 prior unique TKIsFavorable safety and tolerability profile with 161 patients enrolled and a median treatment duration of 35 weeksAlignment with the FDA on 80 mg QD as the recommended Phase 3 dose and on the 2L+ patient population for the ENABLE-2 pivotal trial, which is expected to initiate in the second half of this year BURLINGAME, Calif., June 11, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today presented updated positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML). An oral presentation will be delivered later today at the European Hematology Association (EHA) 2026 Congress, taking place June 11-15 in Stockholm, Sweden, and virtually. The Company also provided an update on recent regulatory interactions with the Food and Drug Administration (FDA). Enliven will host a webcast and conference call today, June 11, at 8:30 a.m. ET / 2:30 p.m. CEST."Despite recent advances in CML treatment, there remains a need for highly effective therapies with excellent safety and tolerability profiles optimized for long-term treatment and capable of deep and durable molecular responses," said Dennis Kim, M.D., Professor of Medicine in the Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. "The updated data from the ENABLE trial are very promising and encouraging. The trial demonstrated meaningful responses across lines of therapy in heavily pretreated patients, including responses in patients who had shown a lack of efficacy to the most effective approved therapies. Further, ELVN-001 demonstrated a favorable safety and tolerability profile, reflecting its high selectivity. I look forward to the initiation of the planned Phase 3 ENABLE-2 trial, which could establish ELVN-001 as an important new treatment option for patients with previously treated CML.""These promising results continue to showcase the consistency of ELVN-001's overall profile and reinforce its potential to be a best-in-class ATP-competitive inhibitor with differentiated activity relative to allosteric inhibitors," said Helen Collins, M.D., Chief Medical Officer of Enliven. "In these data, we observed higher response rates in patients treated in earlier lines of therapy, and comparable response rates regardless of prior asciminib exposure. We are also thrilled by the outcome of our recent End-of-Phase 1 meeting with the FDA, where we reached alignment on the 80 mg once daily dose and the inclusion of patients who have received at least one prior TKI in the planned ENABLE-2 Phase 3 trial. This is an important milestone as we advance towards initiating ENABLE-2 later this year."ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA are from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377).ELVN-001 Updated Data Highlights ENABLE Has Enrolled a Heavily Pretreated Patient PopulationAs of the cutoff date of March 10, 2026, 161 patients were enrolled in the ongoing Phase 1 trial across dose levels ranging from 10-240 mg daily.Most patients (76%) remain on study with a median treatment duration of 35 weeks.Patients enrolled were heavily pretreated, with 70% having received three or more prior unique TKIs and 23% having received five or more unique TKIs.62% of patients received prior asciminib, and these patients were more heavily pretreated than the overall trial population: 93% received three or more prior unique TKIs, and 34% received five or more unique TKIs.8% of patients enrolled with mutations associated with resistance to allosteric inhibitors, increasing from 4% in Phase 1a to 11% in Phase 1b.Encouraging ELVN-001 Efficacy Data by 24 WeeksOf the 90 patients enrolled in the Phase 1b, 78 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 69 patients were evaluable for major molecular response (MMR) by 24 weeks.Additionally, of the 49 patients enrolled in the 80 mg once daily (QD) Phase 1b cohort, 37 had typical BCR::ABL1 transcripts and had at least one post-baseline transcript; 28 patients were evaluable for MMR by 24 weeks.Cohort (n = evaluable for MMR)Phase 1bPhase 1b 80 mg QD
CohortOverall MMR54% (n=69)61% (n=28)Achieved MMR40% (n=53)48% (n=21)Maintained MMR100% (n=16)100% (n=7)Deep Molecular Response (DMR) achievement rates were also encouraging.By 24 weeks, DMR was achieved in 22% of patients in the overall Phase 1b and 30% of patients in the 80 mg QD Phase 1b cohort.Response rates were higher in less heavily pretreated patients, and prior asciminib exposure did not meaningfully impact response rates.Achieved Response Rates by 24-weeks (n = evaluable for MMR)Prior number of unique TKIs:Phase 1b (n=69)Phase 1b post-asciminib (n=43)1-255% (n=27)60% (n=6)3-432% (n=26)28% (n=22)5+29% (n=16)29% (n=15)ELVN-001's Safety Profile Consistent with High Selectivity for ABL1ELVN-001 was generally well-tolerated, consistent with its high selectivity.6% of patients discontinued due to adverse events.The majority of treatment-emergent adverse events (TEAEs) were Grade 1 or 2.Grade ≥3 TEAEs were reported in 53/158 (34%) patients overall; with thrombocytopenia (6%), neutropenia (6%) and lipase elevation (6%) as the most common.At the biologically optimal dose of 80 mg QD (n=62), Grade ≥3 TEAEs were reported in 15/62 (24%) patients, with thrombocytopenia (6%) being the only Grade ≥3 TEAE reported in >5% of patients.Key Outcomes from the End-of-Phase 1 Meeting with the FDA80 mg QD selected as the recommended dose for Phase 3 ENABLE-2 trial.ENABLE-2 is expected to enroll patients with CML previously treated with one or more TKIs, and to be randomized to receive either ELVN-001 or physician's choice of an ATP-competitive TKI.Additional details of the Phase 3 trial design are expected to be finalized following further discussions with the FDA, including at a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.The oral presentation titled: "ENABLE: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML" will be presented today at 5:45 p.m. CEST during the European Hematology Association Congress in Stockholm, Sweden, by Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. A copy of the presentation will be available on the "Program Presentations & Publications" section of the Company's website at www.enliventherapeutics.com.Webcast and Conference Call Information
Enliven will host a live webcast and conference call today at 8:30 a.m. ET / 2:30 p.m. CEST. To participate in the live event, please register using this link. Following registration, participants will have access to dial in numbers and a unique passcode should they prefer to participate by phone. The event and accompanying slides can also be accessed by visiting the investor relations section of the Company's website at https://ir.enliventherapeutics.com. An archived webcast will be available on the Company's website following the event.About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. ELVN-001, a highly selective active-site TKI, has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn and XForward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential profile, activity, selectivity, safety, tolerability, efficacy, differentiated attributes, therapeutic benefit and potential best-in-class or complementary profile of ELVN-001 to allosteric inhibitors; the interpretation of data from the ongoing ENABLE trial, including MMR rate, safety and tolerability data; comparisons to historical or precedent clinical trial results; the timing, content and availability of additional clinical data and presentation materials; the continued conduct, design, objectives, endpoints, dose selection and future clinical evaluation of ELVN-001, including the planned ENABLE-2 Phase 3 trial, the potential timing of initiation of ENABLE-2, the potential timing and outcome of further FDA discussions and the finalization of additional Phase 3 trial design details; and statements by Enliven's Chief Medical Officer, and Dennis Kim, M.D., Professor of Medicine, Department of Medical Oncology and Hematology at the Princess Margaret Cancer Centre, Canada. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation; the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of ELVN-001 to differ from the results of earlier trials of ELVN-001; ELVN-001 failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in ELVN-001 clinical trials; the risks of delays in completing the ongoing ENABLE trial or initiating ENABLE-2; Enliven failing to complete the ongoing ENABLE trial, to present additional data, to initiate ENABLE-2 or to advance ELVN-001 through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; lack of reliability of cross-trial comparisons because the referenced data are derived from different clinical trials at different points in time, with differences in trial design and patient populations, and results may differ in head-to-head studies; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for ELVN-001; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, ELVN-001 or other product candidates; Enliven's limited resources; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.Head-to-Head ComparisonsThe Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release are derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-updated-positive-phase-1-clinical-data-and-alignment-with-fda-on-key-phase-3-trial-design-components-302797424.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics Announces Updated Positive Phase 1 Clinical Data and Alignment with FDA on Key Phase 3 Trial Design Components
US Market News
1週前
Enliven Therapeutics to Host Webcast Conference Call to Discuss Phase 1 ELVN-001 Clinical Data Being Presented at EHA 2026 CongressJune 3, 2026 4:05 PM
PR Newswire (US) Enliven will host a webcast conference call on June 11, at 8:30 a.m. ETBURLINGAME, Calif., June 3, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced that the Company will host a webcast conference call on Thursday, June 11, 2026 at 8:30 a.m. ET to discuss updated data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with previously treated chronic myeloid leukemia (CML) that will be presented at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden, and virtually. The EHA Congress oral presentation will take place on Thursday, June 11, at 5:45 p.m. CEST / 11:45 a.m. ET.Company webcast and conference call informationDate and time: Thursday, June 11, 8:30 a.m. ET / 2:30 p.m. CESTAccess details: To participate in the live event, please register using this link. Following registration, participants will have access to dial-in numbers and a unique passcode should they prefer to participate by phone. The event and accompanying slides can also be accessed by visiting the investor relations section of the Company's website at https://ir.enliventherapeutics.com/. An archived webcast will be available on the Company's website following the event.Details of the 2026 EHA oral presentation are as follows:
Title: ENABLE: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML
Presenter: Dennis Kim, M.D.
Session Title: s416 Chronic myeloid leukemia – Clinical
Location: A12 Hall
Abstract Number: S164
Presentation Date/Time: June 11, 5:45 p.m. - 6:00 p.m. CEST / 11:45 a.m. ETThe abstract is available on the EHA website. Following the EHA oral presentation, a copy will be available on the "Program Presentations & Publications" section of the Company's website at www.enliventherapeutics.com.About the ENABLE TrialThe ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to tyrosine kinase inhibitors (TKIs). Secondary endpoints include pharmacokinetics, major molecular response (MMR) by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.About ELVN-001ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. ELVN-001, a highly selective active-site TKI, has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.About Enliven Therapeutics Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn?and?X. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-to-host-webcast-conference-call-to-discuss-phase-1-elvn-001-clinical-data-being-presented-at-eha-2026-congress-302790671.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics to Host Webcast Conference Call to Discuss Phase 1 ELVN-001 Clinical Data Being Presented at EHA 2026 Congress
US Market News
1月前
Enliven Therapeutics Announces Oral Presentation at the EHA 2026 Congress Featuring Additional Positive Phase 1 Clinical Trial Data for ELVN-001 in CMLMay 12, 2026 9:53 AM
PR Newswire (US) Abstract includes previously reported data: cumulative MMR rate of 47% with 38% of patients achieving MMR by 24 weeks in mature, heavily pretreated 80 mg QD Phase 1b cohortIn patients who previously received asciminib, cumulative MMR rate was 52%, with 38% of patients achieving MMR by 24 weeksELVN-001 maintained a favorable safety and tolerability profile with 141 patients enrolled and a median treatment duration of ~32 weeks EHA presentation will include updated data with additional patients and longer treatment durationBOULDER, Colo., May 12, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today announced additional, positive data from the Phase 1 ENABLE clinical trial evaluating ELVN-001 in patients with chronic myeloid leukemia (CML) in an abstract accepted for an oral presentation at the European Hematology Association (EHA) 2026 Congress taking place June 11-14 in Stockholm, Sweden and virtually. Updated data will be presented during an oral presentation at the conference on Thursday, June 11, at 5:45 p.m. CEST /11:45 a.m. ET.ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL1 gene fusion, the oncogenic driver for patients living with CML. Data presented at EHA will be from the ongoing ENABLE Phase 1 clinical trial, which enrolled patients with CML that is relapsed, refractory or intolerant to available tyrosine kinase inhibitors (TKIs) (NCT05304377)."As we treat more patients and extend follow-up, ELVN-001 continues to demonstrate robust anti-CML activity in a heavily pretreated patient population," said Helen Collins, M.D., Chief Medical Officer of Enliven. "These results are consistent with our earlier findings demonstrating a favorable safety and tolerability profile, reinforcing ELVN-001's highly selective design. We believe these data and the overall profile of ELVN-001 support its potential to be the best-in-class ATP-competitive inhibitor for patients living with CML. Importantly, ELVN-001's distinct binding mode compared to ATP-competitive inhibitors and complementary mechanism of action to allosteric inhibitors supports its use across lines of treatment. We look forward to sharing additional updates at the EHA Congress in June."Abstract HighlightsPatient DemographicsAs of the cutoff date of December 22, 2025, 141 patients were enrolled in the ongoing Phase 1 trial across dose levels from 10-160 mg once daily (QD), and most patients (76%) remain on study with a median treatment duration of 31.7 weeks.Patients enrolled continue to be heavily pretreated, with 67% having received three or more prior unique TKIs and 24% having received five or more unique TKIs.61% of patients had received prior asciminib, and of those patients, 92% had received three or more prior unique TKIs, and 37% had received five or more unique TKIs.9% of patients enrolled with mutations associated with resistance to asciminib.EfficacyAs previously reported in January 2026:In the initial 80 mg QD Phase 1b cohort (n=19), all patients were evaluable for efficacy by 24 weeks. Of these, 9/19 (47%) were in major molecular response (MMR), with 6/16 (38%) achieving MMR.In the randomized 60 mg and 120 mg QD Phase 1b cohorts (n=41), 26 patients were evaluable for efficacy by 24 weeks, reflecting their more recent enrollment. Of these, 18/26 (69%) were in MMR, with 9/17 (53%) achieving MMR. All patients who received prior asciminib in Phase 1b had an improved or stable response category by week 24. Of these, 14/27 (52%) were in MMR, with 8/21 (38%) achieving MMR.Across all Phase 1b cohorts, 100% of evaluable patients in MMR at enrollment maintained or deepened their response.These data continued to compare favorably to precedent Phase 1 MMR rates for approved BCR::ABL1 TKIs, particularly given the more heavily pretreated patient population in the ELVN-001 clinical trial.Safety ProfileELVN-001 remains well-tolerated, consistent with its highly selective kinase profile.Less than 10% of patients had dose reductions due to treatment-emergent adverse events, and 6.4% of patients discontinued due to adverse events.Details of the oral presentation are as follows:
Title: ENABLE: Updated Efficacy and Safety Results of ELVN-001, a Novel Selective ATP-Competitive Inhibitor of BCR::ABL1, in Patients with Previously Treated CP-CML
Presenter: Dennis Kim, M.D.
Session Title: s416 Chronic myeloid leukemia – Clinical
Location: A12 Hall
Abstract Number: S164
Presentation Date/Time: June 11, 5:45 p.m. - 6:00 p.m. CEST / 11:45 a.m. ETThe abstract is available on the EHA website. Following the presentation, a copy will be available on the "Program Presentations & Publications" section of the Company's website at www.enliventherapeutics.com.About the ENABLE Trial
The ENABLE study (NCT05304377) is a Phase 1 study of ELVN-001 in patients with previously treated CML. ENABLE is a dose escalation and expansion trial designed to evaluate safety and tolerability and to determine the recommended dose for further clinical evaluation of ELVN-001 in patients with CML with and without T315I mutations that is relapsed, refractory or intolerant to TKIs. Secondary endpoints include pharmacokinetics, MMR by central quantitative reverse transcriptase polymerase chain reaction, duration of MMR, BCR::ABL1 transcript levels and complete hematologic response.About ELVN-001
ELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia. As a highly selective active-site TKI, ELVN-001 has a mechanism of action that is complementary to allosteric BCR::ABL1 inhibitors, which may play an increasingly important role in the standard of care. ELVN-001 was also designed to have activity against the T315I mutation, the most common BCR::ABL1 mutation, which confers resistance to nearly all approved TKIs, as well as activity against mutations known to confer resistance to allosteric BCR::ABL1 inhibitors.About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn?and?X.Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of Enliven's management, as well as assumptions made by, and information currently available to, Enliven's management. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to: statements regarding the potential profile, activity, selectivity, safety, tolerability, efficacy, differentiated attributes, therapeutic benefit and potential best-in-class or complementary profile of ELVN-001; the interpretation of data from the ongoing ENABLE trial, including MMR rate, safety and tolerability data; comparisons to historical or precedent clinical trial results; the timing, content and availability of additional clinical data and presentation materials; the continued conduct, design, objectives, endpoints, dose selection and future clinical evaluation of ELVN-001; and statements by Enliven's Chief Medical Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation; the potential for interim, topline and preliminary results from Enliven's clinical trials to materially change as additional patient data become available or following more comprehensive review; the potential for results from the ongoing or any future clinical trial of ELVN-001 to differ from the results of earlier trials of ELVN-001; ELVN- failing to demonstrate sufficient safety, efficacy, tolerability, durability, differentiated attributes or therapeutic benefit in current or future clinical trials; risks associated with unexpected events during the remainder of the ENABLE trial including serious adverse events, toxicities, dose reductions, discontinuations or other undesirable side effects; delays or difficulties in recruiting, enrolling or maintaining patients in ELVN-001 clinical trials; the risks of delays in completing the ongoing ENABLE trial; Enliven failing to complete the ongoing ENABLE trial, to present additional data or to advance ELVN-001 through clinical development; regulatory authorities disagreeing with Enliven's clinical trial design, dose selection, endpoints or interpretation of data, or requiring additional studies or diagnostics; lack of reliability of cross-trial comparisons because the referenced data are derived from different clinical trials at different points in time, with differences in trial design and patient populations, and results may differ in head-to-head studies; developments relating to Enliven's competitors and industry which may affect the development or potential market opportunity for ELVN-001; and the potential inability of Enliven to obtain regulatory approval for, or ultimately commercialize or license, ELVN-001 or other product candidates; Enliven's limited resources; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties are more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and Form 10-Q filed with the SEC and in Enliven's future SEC filings. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.Head-to-Head ComparisonsThe Company has not performed any head-to-head trials for ELVN-001. As a result, the data referenced in this press release is derived from different clinical trials at different points in time, with differences in trial design and patient populations. As a result, conclusions from cross-trial comparisons cannot be made. View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-announces-oral-presentation-at-the-eha-2026-congress-featuring-additional-positive-phase-1-clinical-trial-data-for-elvn-001-in-cml-302769668.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics Announces Oral Presentation at the EHA 2026 Congress Featuring Additional Positive Phase 1 Clinical Trial Data for ELVN-001 in CML
US Market News
1月前
Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business UpdateMay 7, 2026 4:05 PM
PR Newswire (US) Phase 1 data update for ELVN-001 expected mid-2026 Initiation of the Phase 3 ENABLE-2 pivotal trial of ELVN-001 expected in the second half of 2026Strong balance sheet with $452 million in cash, cash equivalents and marketable securities, which is expected to provide cash runway into the first half of 2029BOULDER, Colo., May 7, 2026 /PRNewswire/ -- Enliven Therapeutics, Inc. (Enliven or the Company) (Nasdaq: ELVN), a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics, today reported financial results for the first quarter ended March 31, 2026, and provided a business update."Recent strategic momentum in CML validates a remaining unmet need and a compelling long-term opportunity. Against this backdrop, we remain focused on execution as we prepare to initiate the Phase 3 pivotal trial of ELVN-001 in the second half of 2026," said Rick Fair, Chief Executive Officer of Enliven. "Based on the Phase 1 data generated to date, we believe ELVN-001 has the potential to be the best-in-class ATP-competitive inhibitor in CML and that it is positioned strongly to compete across all lines of therapy."ELVN-001 Program HighlightsELVN-001 is a potent, highly selective, potentially best-in-class small molecule kinase inhibitor designed to specifically target the BCR::ABL gene fusion, the oncogenic driver for patients with chronic myeloid leukemia (CML).In January 2026, the Company announced positive initial Phase 1b data for ELVN-001, reinforcing ELVN-001's positioning as the potentially best-in-class ATP-competitive inhibitor in CMLEnrollment continued in the 80 mg once daily expansion cohort of the Phase 1b trial evaluating ELVN-001 in patients with previously treated CML (NCT05304377)The Company remains on track to achieve its anticipated 2026 milestones, including:Mid-year presentation of additional Phase 1 data from the ongoing ENABLE trialRegulatory interactions with the FDA on dose selection and Phase 3 trial designInitiation of Phase 3 ENABLE-2 in the second half of 2026First Quarter 2026 Financial Results Cash Position: As of March 31, 2026, the Company had cash, cash equivalents and marketable securities totaling $452.4 million, which is expected to provide cash runway into the first half of 2029.Research and development (R&D) expenses: R&D expenses were $20.7 million for the first quarter of 2026, compared to $24.9 million for the first quarter of 2025.General and administrative (G&A) expenses: G&A expenses were $7.1 million for the first quarter of 2026, compared to $6.8 million for the first quarter of 2025.Net Loss: Enliven reported a net loss of $23.6 million for the first quarter of 2026, compared to a net loss of $28.5 million for the first quarter of 2025.About Enliven Therapeutics
Enliven is a clinical-stage biopharmaceutical company focused on the discovery and development of small molecule therapeutics to help people not only live longer, but live better. Enliven aims to address existing and emerging unmet needs with a precision medicine approach that improves survival and enhances overall well-being. Enliven's discovery process combines deep insights into clinically validated biological targets and differentiated chemistry to design potentially first-in-class or best-in-class therapies. Enliven is based in Boulder, Colorado. To learn more, visit www.enliventherapeutics.com and connect with us on LinkedIn and X. Forward-Looking Statements
This press release contains forward-looking statements (including within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and Section 27A of the Securities Act of 1933, as amended) concerning Enliven and other matters that involve substantial risks and uncertainties. These statements may discuss goals, intentions and expectations as to future plans, trends, events, results of operations and financial condition, or otherwise, based on current beliefs of the management of Enliven, as well as assumptions made by, and information currently available to, management of Enliven. Forward-looking statements generally include statements that are predictive in nature and depend upon or refer to future events or conditions, and include words such as "may," "will," "should," "would," "expect," "anticipate," "plan," "likely," "believe," "estimate," "project," "intend," and other similar expressions or the negative or plural of these words, or other similar expressions that are predictions or indicate future events or prospects, although not all forward-looking statements contain these words. Statements that are not historical facts are forward-looking statements. Forward-looking statements in this press release include, but are not limited to, statements regarding the potential of, and plans regarding, market opportunities, and expectations regarding Enliven's ELVN-001 program; statements regarding the potential long-term opportunity in CML; expected milestones for ELVN-001, including the potential timing for the presentation of additional Phase 1 data from the ongoing ENABLE trial, the potential timing of regulatory interactions with the FDA on dose selection and Phase 3 trial design, and potential timing of the initiation of Phase 3 ENABLE-2; Enliven's expected cash runway; statements regarding ELVN-001's positioning as the potentially best-in-class ATP-competitive inhibitor in CML, and its positioning to strongly compete across all lines of therapy; and statements by Enliven's Chief Executive Officer. Forward-looking statements are based on current beliefs and assumptions that are subject to risks and uncertainties and are not guarantees of future performance. Actual results could differ materially from those contained in any forward-looking statement as a result of various risks and uncertainties, including, without limitation: the potential for the results of the ongoing or any future clinical trial of ELVN-001 to differ from the results from earlier trials of ELVN-001; the risk of delays in completing the ongoing ENABLE trial or initiation of a Phase 3 trial of ELVN-001; risks associated with unexpected events during the remainder of the ongoing ENABLE trial, including adverse events, toxicities or other undesirable side effects; the risk of difficulties in recruiting, enrolling or maintaining patients in clinical trials of ELVN-001; the limited operating history of Enliven; the ability to advance product candidates through preclinical and clinical development; the ability to obtain regulatory approval for, and ultimately commercialize or license, product candidates; the outcome of preclinical testing and early clinical trials for product candidates and the potential that the outcome of preclinical testing and early clinical trials may not be predictive of the success of later clinical trials, including extrapolations or predictions regarding the safety and efficacy of ELVN-001 based on comparisons to published results of trials of other products, which may be different when evaluated in head-to-head studies; Enliven's limited resources; the risk of failing to demonstrate safety and efficacy of product candidates; the risk that FDA disagrees with Enliven's clinical trial design or Enliven's interpretation of the data; the risk that regulatory authorities may require Enliven to develop and obtain approval for a companion diagnostic in connection with the approval of a product candidate; Enliven's limited experience as a company in designing and conducting clinical trials; the potential for interim, topline, and preliminary data from Enliven's preclinical studies and clinical trials to materially change in the final data; developments relating to Enliven's competitors and its industry, including competing product candidates and therapies; the potential market opportunity for any of Enliven's programs; the decision to develop or seek strategic collaborations to develop Enliven's current or future product candidates in combination with other therapies and the cost of combination therapies; the ability to attract, hire, and retain highly skilled executive officers and employees; the ability of Enliven to protect its intellectual property and proprietary technologies; the scope of any patent protection Enliven obtains or the loss of any of Enliven's patent protection; reliance on third parties, including medical institutions, contract manufacturing organizations, contract research organizations and strategic partners; geo-political developments, general market or macroeconomic conditions; Enliven's ability to obtain additional capital to fund Enliven's general corporate activities and to fund Enliven's research and development; and other risks and uncertainties, including those more fully described in Enliven's filings with the Securities and Exchange Commission (SEC), which may be found in the section titled "Risk Factors" in Enliven's Annual and Quarterly Reports on Form 10-K and 10-Q filed with the SEC and in Enliven's future reports to be filed with the SEC. Except as required by applicable law, Enliven undertakes no obligation to revise or update any forward-looking statement, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.This press release contains hyperlinks to information that is not deemed to be incorporated by reference into this press release.Enliven Therapeutics, Inc.Selected Condensed Consolidated Financial Information(in thousands, except per share data)(unaudited) Statements of Operations
Three Months Ended March 31,
2026
2025Operating expenses:
Research and development
$ 20,687
$ 24,895 General and administrative
7,136
6,798Total operating expenses
27,823
31,693Loss from operations
(27,823)
(31,693)Other income (expense), net
4,196
3,149Net loss
$ (23,627)
$ (28,544)Net loss per share, basic and diluted
$ (0.38)
$ (0.57)Weighted-average shares outstanding,
basic and diluted
62,799
50,051
Balance Sheets March 31,
December 31,
2026
2025Assets
Current assets:
Cash, cash equivalents and marketable securities$ 452,401
$ 462,621 Prepaid expenses and other current assets10,736
12,257Total current assets463,137
474,878Property and equipment, net20
34Operating lease right-of-use assets290
383Deferred offering costs217
217Other long-term assets1,188
656Total assets$ 464,852
$ 476,168Liabilities and Stockholders' Equity
Current liabilities:
Accounts payable$ 1,640
$ 2,159 Accrued expenses and other current liabilities9,847
14,409Total current liabilities11,487
16,568Total liabilities11,487
16,568Stockholders' equity453,365
459,600Total liabilities and stockholders' equity$ 464,852
$ 476,168 View original content to download multimedia:https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-first-quarter-financial-results-and-provides-a-business-update-302765868.htmlSOURCE Enliven Therapeutics, Inc. Original: Enliven Therapeutics Reports First Quarter Financial Results and Provides a Business Update