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# Enliven Therapeutics Gets FDA Agreement On Leukemia Trial Design As Quarterly Loss Widens
- URL: https://www.bullished.co/enliven-therapeutics-gets-fda-agreement-on-leukemia-trial-design-as-quarterly-loss-widens-80679ff2/
- Published: 2026-11-06T20:20:48.000Z
- Updated: 2026-11-06T20:20:48.000Z
- Description: The drug developer expects to begin its first pivotal trial before year-end, with $884.4 million available to fund operations.
- Author: Matteo Parrino
- Tags: SEC Filings, ELVN, Industry: Healthcare

Enliven Therapeutics, which develops small-molecule medicines, [reached agreement](https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-third-quarter-2026-financial-results-and-provides-a-business-update-302931099.html?ref=bullished.co) with the FDA on the design of its first pivotal leukemia trial and expects to begin it before year-end 2026\. The company also reported a [$27.7 million loss](https://www.sec.gov/Archives/edgar/data/0001672619/000119312526449819/elvn-20261105.htm?ref=bullished.co) for the third quarter, versus $20.1 million a year earlier, in results released Thursday and attached to an SEC filing.

## A 450-Patient Test For Relcobatinib

The planned late-stage study will test relcobatinib, also known as ELVN-001, in adults with chronic myeloid leukemia, a blood cancer, who have received one or more tyrosine kinase inhibitors. Enliven expects to enroll [approximately 450 patients](https://www.sec.gov/Archives/edgar/data/0001672619/000119312526449819/elvn-ex99%5F1.htm?ref=bullished.co), assigning them equally to its drug or a treatment selected by the investigator.

Patients assigned to relcobatinib would receive 80 milligrams daily. The comparison treatments are dasatinib, nilotinib and bosutinib. The trial's main goal is major molecular response at week 24—a measure of treatment response that Enliven says could support accelerated approval. The same measure at week 96 could support full approval.

Rick Fair, chief executive officer of Enliven Therapeutics, said the FDA agreement provided “a clear path to initiate our [first pivotal trial](https://www.sec.gov/Archives/edgar/data/0001672619/000119312526449819/elvn-ex99%5F1.htm?ref=bullished.co).” Agreement on the study design is a step toward testing the drug, rather than approval of the medicine.

## More Spending, $884.4 Million Available

Enliven's research spending reached [$28.0 million](https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-third-quarter-2026-financial-results-and-provides-a-business-update-302931099.html?ref=bullished.co) in the third quarter, compared with $18.2 million a year earlier. Administrative spending was $8.0 million, against $6.9 million, while the loss per share widened to $0.36 from $0.32.

Cash, cash equivalents and marketable securities totaled $884.4 million as of September 30, 2026\. Management estimates those resources will support operations into 2030.

ELVN shares soared about 10% to $49.14 in Friday trading following Thursday's results and business update. The company's market value was $3.3 billion in Friday trading.

## From Early Testing To Pivotal Study

Relcobatinib is Enliven's main drug candidate. Its early-stage trial studies adults whose leukemia resisted earlier treatments or who could not tolerate them; enrollment stood at 90 patients at the April 28, 2025, data cutoff.

The medicine is designed to target BCR::ABL1, the gene fusion that drives this leukemia, including mutations associated with resistance to other treatments. Enliven said preclinical findings published in Leukemia showed activity against a range of treatment-resistant mutations. Clinical findings from the early-stage study were also presented at meetings of the Society of Hematologic Oncology, International CML Foundation, Japanese Society of Hematology and German Society for Hematology and Medical Oncology.

Enliven holds worldwide development and commercial rights to its candidates and uses outside manufacturers for testing supplies. Its early research also includes Graves’ disease. The company appointed Kristine Ball to its board.

Enliven says it remains on track to begin the pivotal relcobatinib study before year-end 2026.

Learn

- [Item 2.02: results of operations →](https://www.bullished.co/learn/8-k-items-explained/#item-202-results-of-operations)  
From 8-K Items Explained: What Every Item Code From 1.01 To 9.01 Tells You, With Examples

### Sources

- [8-K Filing — Enliven Therapeutics, Inc. (ELVN)](https://www.sec.gov/Archives/edgar/data/0001672619/000119312526449819/elvn-20261105.htm?ref=bullished.co) — SEC EDGAR
- [Exhibit elvn-ex99\_1.htm — Enliven Therapeutics, Inc. 8-K exhibit](https://www.sec.gov/Archives/edgar/data/0001672619/000119312526449819/elvn-ex99%5F1.htm?ref=bullished.co) — SEC EDGAR
- [Enliven Therapeutics Reports Third Quarter 2026 Financial Results and Provides a Business Update](https://www.prnewswire.com/news-releases/enliven-therapeutics-reports-third-quarter-2026-financial-results-and-provides-a-business-update-302931099.html?ref=bullished.co) — prnewswire.com