BRIEF—Concert Pharma gets 'Breakthrough' status for alopecia candidate

Concert Pharmaceuticals’ shares were up nearly 18% at $11.76 pre-market today, after it said that the US Food and Drug Administration has granted Breakthrough Therapy designation for its oral Janus kinase inhibitor, CTP-543, for the treatment of moderate-to-severe alopecia areata.

There are currently no drugs approved by the FDA for the treatment of alopecia areata, an autoimmune disorder in which the immune system attacks hair follicles, resulting in patchy or complete hair loss.

“We are pleased that the FDA has recognized the therapeutic potential of CTP-543 as a new treatment in development for alopecia areata,” said Roger Tung, president and chief executive of Concert Pharmaceuticals, adding: “Our goal is to bring this potential new therapy to patients as quickly as possible. We look forward to working closely with the FDA to expedite the development of CTP-543.”

As the next step in the CTP-543 clinical program, Concert intends to initiate its Phase III clinical program in the fourth quarter of 2020.