Shares of Cytokinetics (CYTK -60.1%) are set for an ugly day of trading after its lead product tirasemtiv misses its Phase 2b primary endpoint of significantly improving muscle function compared to placebo in ALS patients.
The disappointing result forces the company to consider ending the product's development. Last year the firm made a dosing error in the clinical trial when it mistakenly gave placebos to patients in the treatment arm. The foul-up delayed the trial by three months and forced it to take a $5M charge.
The company's other lead program, omecamtiv mecarbil via a partnership with Amgen, also failed a Phase 2b trial (IV formulation) last September. Amgen awaits the results of a mid-stage trial on an oral formulation before deciding to proceed or exit.
The landscape for good news looks barren.