Business
Rigel Pharmaceuticals and Forma Therapeutics Announce Licensing Agreement for Olutasidenib, a Novel Mutant IDH1 Inhibitor for the Potential Treatment of Relapsed or Refractory Acute Myeloid Leukemia
Registrational Phase 2 data demonstrate olutasidenib's potential as a market-leading, oral, mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor for the
About this update from Rigel Pharmaceuticals, Inc.
[{"type":"text","content":"Registrational Phase 2 data demonstrate olutasidenib's potential as a market-leading, oral, mutant isocitrate dehydrogenase 1 (mIDH1) inhibitor for the treatment of relapsed or refractory acute myeloid leukemiaFDA has accepted Forma's NDA for olutasidenib, with a PDUFA target action date of February 15, 2023Forma to receive an upfront payment of $2.0 million and is eligible to receive an additional $17.5 million upon the achievement of certain near-term regulatory, approval, and first commercial sale milestones, as well as potential future development and commercial milestone payments of $215.5 million and tiered royalties in the low-teens to mid-thirtiesIf approved, olutasidenib would be Rigel's second commercial product in hematology-oncology and highly synergistic with Rigel's existing commercial and medical affairs infrastructureRigel to host conference call today to discuss transaction details at 4:30 p.m. Eastern Time and will be joined by Key Opinion Leader and olutasidenib Phase 2 trial investigator, Jorge E. Cortes, M.D.SOUTH SAN FRANCISCO, Calif. and WATERTOWN, Mass., Aug. 2, 2022 /PRNewswire/ -- Rigel Pharmaceuticals, Inc. (Nasdaq: RIGL) and Forma Therapeutics, Inc. (Nasdaq: FMTX) today announced that they have entered into an exclusive, worldwide license agreement to develop, manufacture and commercialize olutasidenib, an oral, small molecule inhibitor of mIDH1 being investigated for the treatment of relapsed/refractory acute myeloid leukemia (R/R AML) and other malignancies. \nIn a Phase 2 registrational study of olutasidenib in patients with mIDH1 R/R AML, olutasidenib demonstrated a robust composite complete remission rate and duration of response and was well-tolerated. 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.\n\"Olutasidenib is a potential market-leading treatment that we believe, based on the registrational Phase 2 data, can improve outcomes in patients with mIDH1+ relapsed or refractory acute myeloid leukemia, and is a strategic fit for our business,\" said Raul Rodriguez, Rigel's president and CEO. \"This transaction expands our hematology-oncology portfolio and enables us to leverage our strong commercial capabilities to provide a potential new therapy for t...