Josh Cohen (L) and Justin Klee, Amylyx co-CEOs

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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