CNCE - Concert retains breakthrough status for hair loss therapy despite rival entry

• Concert Pharmaceuticals ( NASDAQ: CNCE ) announced Wednesday that the FDA allowed the company to keep its Breakthrough Therapy Designation for hair loss therapy deuruxolitinib, despite the agency’s approval of a rival therapy.
• In 2020, the FDA initially issued Breakthrough Therapy Designation for the oral Janus kinase (JAK) inhibitor, deuruxolitinib, to treat adults with moderate to severe alopecia areata.
• However, with the approval of a rival JAK inhibitor as the first treatment for the hair loss condition, the agency has informed that Concert’s ( CNCE ) Breakthrough Therapy Designation for deuruxolitinib was under review.
• FDA’s Breakthrough Therapy designation aims to speed up the development and review of treatments targeted at serious or life-threatening conditions. With its full features, a breakthrough therapy developer can receive intensive regulatory guidance with potential eligibility for FDA’s priority review.
• The decision comes after a review of additional findings, including positive data from two Phase 3 clinical trials that Concert ( CNCE ) submitted to the FDA to maintain the Breakthrough status.
• In June 2022, oral JAK inhibitor Olumiant (baricitinib) developed by Eli Lilly ( LLY ) and Incyte ( INCY ) became the first FDA-cleared systemic treatment for alopecia areata.

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