Cytokinetics' commercial ambitions met another late-stage stonewall, with the company’s amyotrophic lateral sclerosis (ALS) prospect coming up short when investigators took a look under the clinical hood.
Cytokinetics’ reldesemtiv has missed the primary endpoint in a phase 2 amyotrophic lateral sclerosis (ALS) trial. The Astellas-partnered drug failed to beat placebo on a lung function test, but Cytokinetics thinks a post hoc analysis shows a path forward for the program.
Three months after the FDA dropped a clinical hold on Solid Biosciences $SLDB over safety concerns related to their gene therapy for Duchenne muscular dystrophy, the biotech is back in business. Execs said Monday morning that the hold is gone and the FDA has signed off on their response.