Rigel Pharma and Forma Therapeutics enter AML licensing deal

US biotech Rigel Pharmaceuticals (Nasdaq: RIGL) and Forma Therapeutics (Nasdaq: FMTX) 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.

In a Phase II 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 US 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.

“Olutasidenib is a potential market-leading treatment that we believe, based on the registrational Phase II 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 chief executive, adding: “This transaction expands our hematology-oncology portfolio and enables us to leverage our strong commercial capabilities to provide a potential new therapy for these patients who remain underserved despite currently available therapies.”