Enliven Therapeutics receives FDA alignment on Phase 3 ENABLE‑2 trial design for relcobatinib
Enliven Therapeutics announced that the U.S. Food and Drug Administration agreed to the design of its pivotal Phase 3 ENABLE‑2 study of relcobatinib (ELVN‑001) in patients with previously treated chronic myeloid leukemia. The trial will randomize about 450 adults to 80 mg daily relcobatinib versus a second‑generation tyrosine‑kinase inhibitor, with major molecular response at week 24 as the primary endpoint. The company expects to start enrollment before the end of 2026.
Why it matters
Guggenheim reiterated a Buy rating and raised its price target to $78, citing the FDA alignment as a catalyst for the upcoming trial. Morgan Stanley, JPMorgan, Barclays and William Blair also initiated coverage with price targets ranging from $70 to $78, reflecting analyst optimism about the trial’s potential impact on the CML market.
Key facts
- 1Enliven reached alignment with the FDA on the final design of the ENABLE‑2 Phase 3 trial for relcobatinib (ELVN‑001). prnewswire.com
- 2The ENABLE‑2 trial will enroll approximately 450 adult patients who have been previously treated with one or more TKIs. prnewswire.com
- 3Patients will be randomized 1:1 to receive relcobatinib 80 mg once daily or an investigator‑selected second‑generation TKI (dasatinib, nilotinib or bosutinib). prnewswire.com
- 4The primary endpoint is major molecular response at Week 24; the key secondary endpoint is major molecular response at Week 96. prnewswire.com
- 5Enliven plans to initiate the trial before year‑end 2026. prnewswire.com
- 6Guggenheim reiterated a Buy rating and set a $78.00 price target after the FDA alignment announcement. investing.com
Summary written by AlphAI from 4 of 4 sources. Not investment advice. Figures are as stated by the linked sources.