Biogen Seeking A Path Forward After Phase III Tofersen Study Fails In ALS
Ionis-Partnered Asset Developed For SOD1 Genetic Mutations
The drug showed favorable but not significant trends across secondary endpoints, and greater efficacy in slower-progressing patients and those treated earlier in the disease, in a small subpopulation.
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SciNeuro’s latest in-licensing deals include three assets for major neurodegenerative diseases from Lilly and Mabylon, but the Chinese bioventure is looking beyond the shopping spree at what it sees as outstanding CNS needs.
After discussions with the US FDA, the company determined it can file AMX0035 based on Phase II/III results and interim Phase III data. Amylyx is sticking with its go-it-alone strategy for global commercialization.