FDA Delays Decision on Syndax Leukemia Drug; Stock Sinks

Shares of Syndax Pharmaceuticals (SNDX) plunged successful intraday trading Monday aft nan biopharmaceutical institution reported that nan Food and Drug Administration (FDA) delayed a determination connected approving its experimental curen for acute leukemia. 

The institution said that nan FDA "extended nan Prescription Drug User Fee Act (PDUFA) action day for nan New Drug Application (NDA)" for revumenib because regulators "required further clip to behaviour a afloat reappraisal of supplemental information" they requested from Syndax. 

Syndax added that nan action day would beryllium pushed backmost by 3 months. The original action day had been group for Sept. 26. 

CEO Says Earlier Trials 'Support Approval'

Chief Executive Officer (CEO) Michael Metzger said that revumenib would beryllium nan first medicine approved to dainty patients with KMT2A-rearranged acute leukemia, a illness pinch debased median endurance rates. Metzger said those affected are a "population pinch important unmet need," adding that investigation from earlier tests of revumenib, positive nan caller information provided, "support approval" by nan FDA.

After nan FDA determination hold news, Syndax Pharmaceuticals shares dropped almost 13% to $21.36 arsenic of 2:40 p.m. ET Monday, falling into antagonistic territory for 2024.