Cytokinetics Sees Enough Evidence To Move Reldesemtiv Into Phase III For ALS
The Astellas-partnered drug did not reach statistical significance on any FORTITUDE-ALS endpoints, but clinically significant results over time justify a longer Phase III study that's likely to enroll ALS patients with a faster rate of disease progression.
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Cytokinetics’ Failure In ALS Clears Way For Focus On Aficamten
With a data monitoring committee finding no signs of efficacy in a Phase III trial of ALS candidate reldesemtiv, Cytokinetics can conserve cash and center on aficamten for hypertrophic cardiomyopathy.
US FDA Reassures ALS Patients In Final Development Guidance
ALS advocates succeed in getting the FDA to soften its stance on use of randomized, placebo-controlled trials for drug development; final guidance also encourages patient-reported outcomes.
Keeping Track: Approval Of First Intranasal Naloxone Copycat Highlights Otherwise Generic Week
The latest drug development news and highlights from our US FDA Performance Tracker.