Every 8-K that Enliven Therapeutics, Inc. (ELVN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow ELVN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full ELVN filings page.
Enliven Therapeutics, Inc. reported financial results for the second quarter ended June 30, 2026 and provided a business update. The company highlighted positive Phase 1 data for ELVN-001 in chronic myeloid leukemia, with a 61% overall major molecular response and 48% achieving major molecular response by 24 weeks at the 80 mg once-daily dose. Earlier-line patients showed 67% overall major molecular response and 55% by 24 weeks. As of the March 10, 2026 cutoff, 161 patients had been enrolled with a median treatment duration of 35 weeks and a favorable safety and tolerability profile.
Following an End-of-Phase 1 FDA meeting, 80 mg once daily was selected as the recommended Phase 3 dose for the planned ENABLE-2 second-line and later trial in CML patients previously treated with one or more TKIs, comparing ELVN-001 to physician’s choice of ATP-competitive TKI. ELVN-001 received Fast Track Designation, and ENABLE-2 is expected to start in the second half of 2026, with further Phase 3 design details to be finalized after a planned End-of-Phase 2 meeting anticipated in the third quarter of 2026.
Enliven reported a strong cash position, with $895.2 million in cash, cash equivalents and marketable securities as of June 30, 2026, expected to provide cash runway into 2030. Second-quarter 2026 research and development expenses were $29.0 million versus $21.5 million a year earlier, and general and administrative expenses were $8.2 million versus $7.1 million. Net loss for the quarter was $32.5 million, compared with $25.3 million in the second quarter of 2025, or $0.49 per share in both periods.
Enliven Therapeutics priced an upsized underwritten public offering of 8,933,334 shares of common stock at $37.50 per share and pre-funded warrants to purchase up to 1,733,333 shares at $37.499 each. All securities are being sold by the company, with expected gross proceeds of about $400.0 million.
Net proceeds are expected to be approximately $376.0 million, or $432.4 million if underwriters fully exercise a 1,600,000-share option. The offering, made off an effective Form S-3ASR shelf, is expected to close on or about June 15, 2026, subject to customary conditions. The pre-funded warrants are exercisable immediately at $0.001 per share and include ownership caps between 4.99% and 19.99%.
Enliven Therapeutics announced updated positive Phase 1 data for its CML drug candidate ELVN-001 and reported key outcomes from an End-of-Phase 1 meeting with the FDA. In Phase 1b, overall major molecular response (MMR) reached 54% in evaluable patients and 61% in the 80 mg once-daily cohort by week 24, with 100% of patients who achieved MMR maintaining it. Response rates by 24 weeks were higher in patients treated earlier in their TKI sequence, including those previously on asciminib. The safety profile was described as favorable and consistent with ELVN-001’s high selectivity, based on 161 enrolled patients and a median treatment duration of 35 weeks. Enliven and the FDA reached alignment on 80 mg once daily as the recommended Phase 3 dose and on a second-line-or-later patient population for the planned ENABLE-2 pivotal trial, which the company expects to initiate in the second half of the year.
Enliven Therapeutics, Inc. reported the results of its annual stockholder meeting and an amendment to its charter. Stockholders approved increasing authorized common stock from 100,000,000 to 200,000,000 shares, and the company filed a Certificate of Amendment making total authorized capital 210,000,000 shares.
Two Class III directors, Richard Fair and Lori Kunkel, were elected to terms ending at the 2029 meeting. Stockholders ratified Deloitte & Touche LLP as independent auditor for the year ending December 31, 2026, approved executive compensation on an advisory basis, and supported holding future say‑on‑pay votes every year.
Enliven Therapeutics reported first quarter 2026 results, highlighting progress on its chronic myeloid leukemia candidate ELVN-001 and a strong cash position. ELVN-001 showed positive initial Phase 1b data, with additional Phase 1 results expected mid-2026 and initiation of the Phase 3 ENABLE-2 pivotal trial planned for the second half of 2026.
For the quarter ended March 31, 2026, Enliven posted a net loss of $23.6 million, improving from $28.5 million a year earlier. Research and development expenses were $20.7 million versus $24.9 million, while general and administrative costs were $7.1 million versus $6.8 million. Cash, cash equivalents and marketable securities totaled $452.4 million, expected to fund operations into the first half of 2029.
Enliven Therapeutics reported fourth quarter and full year 2025 results and highlighted strong progress for its lead CML candidate ELVN-001. Positive initial Phase 1b data in heavily pretreated chronic myeloid leukemia patients showed meaningful major molecular response rates at 80 mg and 60/120 mg once-daily dosing.
The company plans key 2026 milestones, including mid‑year presentation of additional Phase 1 data, regulatory alignment with the FDA on Phase 3 design, and initiation of the pivotal ENABLE-2 trial in the second half of 2026. Recent leadership changes include appointing Rick Fair as CEO and adding Scott Garland to the board.
Enliven ended 2025 with $462.6 million in cash, cash equivalents and marketable securities, expected to fund operations into the first half of 2029. For 2025, R&D expenses were $85.9 million and G&A expenses were $33.8 million, leading to a net loss of $103.7 million, or $1.83 per share.
Enliven Therapeutics reported changes to its board of directors. On January 6, 2026, the board appointed Scott Garland as a Class I director, with his term running until the 2027 annual meeting of stockholders, and named him Chair of the Nominating and Corporate Governance Committee effective January 7, 2026.
Garland previously consulted for the company from January 2024 until his appointment, receiving $314,650 and vesting in stock options to purchase 26,580 shares of common stock. As an outside director, he will receive annual cash compensation of $40,000 for board service and $10,000 for chairing the nominating committee, plus new stock options with a grant date fair value of about $650,000 that vest monthly over three years and fully vest upon a Change in Control. The company also entered into its standard indemnification agreement with him.
On the same day, Andrew Phillips, Ph.D. informed the board that he is resigning from the board, the Audit Committee, and the Nominating Committee effective January 7, 2026. His resignation is stated not to result from any disagreement regarding the company’s operations, policies, or practices.
Enliven Therapeutics, Inc. appointed Richard Fair as President and Chief Executive Officer and a member of the board, effective December 11, 2025, while former CEO Samuel Kintz transitions to Head of Pipeline. Fair brings more than 25 years of product development and commercialization experience from Bellicum Pharmaceuticals, Roche/Genentech, and Johnson & Johnson.
Fair entered into an employment offer letter and a change in control and severance agreement that provide cash severance, bonus eligibility, extended option exercise periods, COBRA premium payments and full vesting of unvested equity awards if he is terminated without cause or resigns for Good Reason, with enhanced benefits in connection with a change in control. The board also adopted the 2025 Inducement Equity Incentive Plan, reserving 875,000 shares of common stock for equity awards to new hires under Nasdaq’s inducement and acquisition exceptions.
Enliven Therapeutics (ELVN) filed an 8‑K/A to amend its November 12, 2025 current report, correcting the press release attached as Exhibit 99.1.
The corrected release covers financial results for the quarter ended September 30, 2025. Information in Items 2.02 and 9.01 (including Exhibit 99.1) is furnished, not filed, under the Exchange Act.
Enliven Therapeutics (ELVN) furnished an 8-K announcing it issued a press release with financial results for the quarter ended September 30, 2025. The release is included as Exhibit 99.1 and was issued on November 12, 2025.
The company notes that the information in Item 2.02 and Exhibit 99.1 is being furnished, not filed, and therefore is not subject to Section 18 liability and is not incorporated by reference into other filings unless expressly stated.