Oct. 13 Quick Takes: Lilly’s Verzenio approved in early breast cancer

FDA approved Verzenio abemaciclib from  Eli Lilly and Co. (NYSE:LLY) for the adjuvant treatment of adult patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, early breast cancer at high risk of recurrence and a Ki-67 score of ≥20%. Verzenio is the only CDK4/6 inhibitor approved in this population — Ibrance from Pfizer Inc. (NYSE:PFE) failed last year, and Kisqali ribociclib from Novartis AG (SIX:NOVN; NYSE:NVS) is being studied. Data for the latter program will not be available until 2025.

Ardelyx Inc. (NASDAQ:ARDX) will lay off 65% of its staff having left a type A meeting with FDA without a path towards approval for its NHE3 sodium transport inhibitor Ibsrela tenapanor in CKD patients on dialysis, for which the company received a complete response letter last July. Tenapanor met its primary and key secondary endpoints, but FDA characterized the magnitude of the treatment effect as “small and of unclear clinical significance.” The agency approved Ibsrela in September 2019 for irritable bowel syndrome with constipation, and Ardelyx partnered with Kyowa Hakko Kirin Co. Ltd. (Tokyo:4151) shortly afterwards. Ardelyx stock closed down 17% at $1.09. ...