FDA stiff arms Evo­lus' ri­val to Al­ler­gan’s block­buster Botox, but ex­ecs promise a snap re­sponse

Evo­lus’ $EOLS at­tempt to field a ri­val to Al­ler­gan’s Botox has run in­to prob­lems at the FDA.

The biotech an­nounced Wednes­day morn­ing that the FDA has hand­ed the com­pa­ny a com­plete re­sponse let­ter for DWP-450 (prabot­u­linum­tox­i­nA). But the ex­ec­u­tive team quick­ly pinned the blame on man­u­fac­tur­ing is­sues, say­ing they can bat their re­vised ap­pli­ca­tion back to reg­u­la­tors in 90 days.

The biotech’s state­ment starts with an an­nounce­ment that the FDA has con­firmed “the fa­vor­able com­ple­tion of its pre-ap­proval in­spec­tion of Dae­woong’s man­u­fac­tur­ing fa­cil­i­ty in South Ko­rea which was pur­pose built for pro­duc­tion of DWP-450.” They go on to say that de­spite the re­jec­tion, they’re stay­ing up­beat — re­gard­less of what in­vestors might think.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER