Shots:

• The submission is based on the P-II (CENTAUR trial) to evaluate AMX0035 vs PBO in 137 patients with ALS at 25 centers of NEALS. The FDA has granted Priority Review & plans to complete with an anticipated PDUFA date on June 29, 2022
• The results showed a reduction in clinical decline @6mos. as measured by revised ALSFRS-R. In survival analysis, the therapy showed a 44% lower risk of death in all randomized patients, median survival through the open-label long-term follow-up (25.0mos. & 18.5mos.)
• The company plans to submit an EAP to the US FDA for the launch of AMX0035 in the US in the coming mos. who are ineligible for participation in the P-III (PHOENIX) clinical trial

Ref: Businesswire | Image: Amylyx