FDA approves Rigel's REZLIDHIA for mIDH1 relapsed/refractory AML

RIGEL PHARMACEUTICALS INC

FDA approved REZLIDHIA (olutasidenib) for adult patients with relapsed/refractory AML with IDH1 mutation.
Phase 2 trial showed 35% CR+CRh rate (51/147) with median duration of response 25.9 months.
Median time to CR or CRh was 1.9 months; 92% of responders achieved CR.
Rigel acquired exclusive worldwide license from Forma Therapeutics in August 2022.
Conference call and webcast today at 6:30 p.m. ET to discuss approval.

This headline and bullets were generated automatically by deepseek-v4-flash:cloud@v2 from the public filing. Read the source on SEC.gov before relying on any specific claim. Not investment advice. See methodology for how this pipeline works.