RegulatoryCompany release

Enliven reaches FDA alignment on Phase 3 ENABLE-2 design for relcobatinib in CML

🇺🇸 Enliven Therapeutics, Inc. (ELVN) · Thu 05 Nov 2026

The US biotech says the agency has agreed the final design of a randomised trial in previously treated chronic myeloid leukaemia, with enrolment due to start before the end of 2026.

Enliven Therapeutics said on 5 November 2026 that it has reached alignment with the US Food and Drug Administration on the final design of ENABLE-2, a randomised Phase 3 trial of relcobatinib (ELVN-001) in patients with previously treated chronic myeloid leukaemia (CML).

The study is planned to enrol about 450 patients. Its primary endpoint is major molecular response at week 24, a measure the company expects could support an application for accelerated approval. Enliven said the trial is on track to begin before the end of 2026.

The company announced the update alongside its third-quarter 2026 financial results. It reported cash of $884.4 million and a net loss of $27.7 million for the quarter, and said its cash runway is expected to extend into 2030.

The summary available does not give further detail on the comparator arm, eligibility criteria or the timing of any data readouts, and those points are not addressed here.

What it means for your team

  • Agreement with the FDA on trial design reduces regulatory uncertainty around ENABLE-2, though it does not guarantee any eventual approval decision.
  • A week-24 molecular response endpoint intended to support accelerated approval would typically be followed by confirmatory evidence requirements; teams tracking CML pipelines should watch for details on these.
  • Market-access and competitive-intelligence teams in CML should note a new randomised late-stage entrant in the previously treated setting, with a trial start expected by end-2026.
  • The company's stated funding runway into 2030 suggests the programme is financed through the planned trial period, according to its own guidance.

Company's press release (SEC filing): Enliven Therapeutics, Inc. ↗

Article written by VigiEye from the official source (Enliven Therapeutics, Inc.). Claims are the company's own. AI-assisted; check the source before acting.

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