Clene Sees Path Forward For ALS Candidate Despite Late-Stage Trial Failure
Touts Survival Signal
The US firm’s nanoparticle candidate has disappointed in a late-stage ALS trial but experts say secondary survival data could prove a silver lining given an increasingly flexible US regulatory environment.
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The company announced detailed data for the drug in the HEALEY-ALS Platform Trial, where the cohort of the Phase II/III study testing it nevertheless failed to meet the primary endpoint.
As signaled when Pfizer acquired Biohaven’s Nurtec and CGRP assets, Biohaven will continue under a modified name, with a focus on epilepsy, obsessive compulsive disorder and spinal muscular atrophy.
Real-world cases of retinal vasculitis linked with Syfovre for geographic atrophy in age-related macular degeneration may have resulted from a material used in a specific filter needle, the US firm revealed, as analysts remained optimistic on the product.