Enliven and FDA Agree on Phase 3 Trial Design for Relcobatinib in Chronic Myeloid Leukemia
Enliven Therapeutics (ELVN) has reached agreement with the U.S. Food and Drug Administration (FDA) regarding the design of a phase 3 clinical trial for relcobatinib, an investigational drug intended to treat chronic myeloid leukemia in patients who have not responded well to previous treatments. The upcoming ENABLE-2 trial is expected to enroll approximately 450 adult participants. This agreement marks a significant step forward in the development of relcobatinib and could lead to regulatory approval if clinical outcomes are favorable. This milestone may positively impact Enliven's stock as it demonstrates progress toward potential commercialization, which can attract investor interest.
Tickers: $ELVN
Topics: CML ENABLE-2 trial FDA pharma relcobatinib