- 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.