In July 2022, Rigel entered into an exclusive, worldwide license agreement with Forma for olutasidenib in all indications.

Rigel in-licensed olutasidenib, an oral, mutant isocitrate dehydrogenase-1 (mIDH1) inhibitor, with exclusive, worldwide rights to develop, manufacture, and commercialize in all indications, including relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies.

Under the terms of the agreement, Forma will receive an upfront payment and is eligible to receive additional near-term regulatory, approval, and first commercial sale milestones.  In addition, Forma is eligible to receive additional development and commercial milestones, and tiered royalties.

Rigel will be responsible for the potential launch and commercialization of olutasidenib in the U.S., and intends to work with potential partners to further develop and commercialize olutasidenib outside the U.S. If approved, olutasidenib would be Rigel’s second commercial product in hematology-oncology and highly synergistic with Rigel’s existing commercial and medical affairs infrastructure.

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Development of olutasidenib:

  • The U.S. Food and Drug Administration (FDA) has accepted Forma’s New Drug Application (NDA) for olutasidenib. The Prescription Drug User Fee Act (PDUFA) target action date is February 15, 2023.