The big R&D PARP victory Clovis CEO Mahaffy spied a few weeks ago? FDA does not buy it – Endpoints News
Amylyx Pharmaceuticals has an uphill battle to face with its ALS drug candidate after FDA advisers recommended not approving it last month. So, while the drug awaits its fate next month, biotechnology is looking to march forward with a fresh look at the data from the study in the middle of the heart of the approval request, despite several ups and downs in the process.
The company released expanded data from a Phase II study with a post hoc analysis that suggested a greater survival benefit for AMX0035, a biotechnology candidate for Lou Gehrig’s disease. The results, published in the journal Muscle and nerveshows that at their cut-off dates in 2020 and 2021, there was a longer median survival rate and a lower risk of death with the drug candidate than there was with placebo.
