That big R&D PARP win Clovis CEO Mahaffy touted a few weeks ago? The FDA isn’t buying it


Amylyx Pharmaceuticals has an uphill battle to face with its ALS drug candidate after FDA advisors recommended against approving it last month. So, as the drug awaits its fate next month, the biotech is looking to march forward with a new look at the data from the mid-stage study at the heart of its approval request, despite several ups and downs in the process.

The company posted extended data from a Phase II study with a post hoc analysis that suggested a larger survival benefit for AMX0035, the biotech’s candidate for Lou Gehrig’s disease. The results, published in the journal Muscle & Nerve, show that by their cutoff dates in 2020 and 2021, there was a longer median survival rate and a lower hazard of death with the drug candidate than there was with the placebo.

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