Dec. 1 Quick Takes: FDA approves Rigel, Forma therapy for AML

There’s a new option for acute myelogenous leukemia after FDA approved Rezlidhia olutasidenib from  Rigel Pharmaceuticals Inc. (NASDAQ:RIGL) more than two months ahead of its Feb. 15 PDUFA date. In August, Rigel licensed rights to the IDH1 inhibitor from Forma Therapeutics Inc. (NASDAQ:FMTX) for $2 million up front, with Forma eligible for $17.5 million in near-term milestones tied to regulatory achievements and first commercial sale, plus up to $215.5 million in further milestones and tiered royalties in the low-teens to mid-thirties. The therapy is approved to treat relapsed or refractory AML with an IDH1 mutation as detected by an FDA-approved test. 

Pfizer Inc. (NYSE:PFE) and Roivant Sciences Ltd. (NASDAQ:ROIV) created a new Roivant subsidiary that will advance clinical assets targeting TNFSF15/TL1A, including a mAb, in the 245-patient, Phase IIb TUSCANY-2 trial for ulcerative colitis. That program, RVT-3101/PF-06480605, has already completed the 50-patient TUSCANY trial. Pfizer will receive a 25% stake in the subsidiary, and Roivant will have an option to co-develop and co-commercialize another antibody against the same target that the partners described as next-generation...