Concert Pharma CTP-543 a Breakthrough Therapy for alopecia areata

The FDA has granted Breakthrough Therapy Designation for Concert Pharmaceuticals’ (NASDAQ:CNCE) oral Janus kinase inhibitor, CTP-543, for the treatment of adult patients with moderate-to-severe alopecia areata, an autoimmune disorder that results in patchy or complete hair loss.

Breakthrough Therapy status provides for more intensive guidance from the FDA on development, the involvement of more senior agency personnel and a rolling review of the marketing application.

Concert Pharma intends to initiate a Phase 3 CTP-543 clinical program in Q4.

https://seekingalpha.com/news/3589402-concert-pharmas-ctpminus-543-breakthrough-therapy-for-alopecia-areata