Amylyx's ALS drug gets a three-month PDUFA delay, setting up the pivotal decision for September
ALS patients in the US are going to have to wait a little bit longer to find out whether they’ll have a new treatment option.
The FDA has extended the review period for Amylyx Pharmaceuticals’ experimental ALS drug AMX0035 by three months, the biotech announced Friday morning, setting up a decision date of Sept. 29. Regulators had previously said the approval or rejection would come by June 29.
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