Af­ter a quick tri­al re­vamp, FDA lifts its clin­i­cal hold on Con­cert’s hair-loss drug

Less than two months af­ter Con­cert Phar­ma­ceu­ti­cals $CNCE rat­tled in­vestors with the news that the FDA had placed a clin­i­cal hold on its drug CTP-543 for alope­cia area­ta, an au­toim­mune con­di­tion linked to com­plete or par­tial hair loss, reg­u­la­tors have now tak­en the agency’s foot off the brakes.

But the biotech says it is al­so amend­ing the tri­al de­sign to test two low dos­es of the drug — 4 mg and 8 mg twice dai­ly — ver­sus a place­bo be­fore they care­ful­ly con­sid­er up­ping the dose.

Endpoints News

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.