Dec. 8 Quick Takes: Amgen’s KRAS inhibitor nears FDA submission; plus Curis, BeiGene, Pfizer, Forma, Agios, Lyra, Bellicum, Illumina-Harvard Pilgrim
Amgen readies sotorasib for FDA
Amgen Inc. (NASDAQ:AMGN) said it plans to submit an NDA for its closely watched KRAS inhibitor sotorasib by year-end to treat locally advanced or metastatic non-small cell lung cancer (NSCLC) with KRAS G12C mutation. The agency also granted the compound breakthrough therapy designation and accepted it into its real-time cancer review pilot.
ASH data propel Curis shares
Shares of Curis Inc. (NASDAQ:CRIS) rose 355% to $6.55 after the company reported preliminary Phase I data at the American Society of Hematology meeting for CA-4948. Six of seven relapsed or refractory non-Hodgkin lymphoma patients receiving the recommended Phase II dose of the IRAK4 inhibitor had reductions in tumor size of 6-67%. The company ended the day with a market cap of $385 million...