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FDA places Concert Pharma's mid-stage study of CTP-543 in hair loss disorder on clinical hold pending review of non-clinical toxicology studies; shares down 16% premarket

Published 05/17/2017, 08:09 AM
© Reuters.  FDA places Concert Pharma's mid-stage study of CTP-543 in hair loss disorder on clinical hold pending review of non-clinical toxicology studies; shares down 16% premarket
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  • At the FDA's request, Concert Pharmaceuticals (NASDAQ:CNCE) has to submit the results of non-clinical toxicology studies for agency review prior to dosing patients in its Phase 2a study of CTP-543 for the treatment of alopecia areata, an autoimmune disorder characterized by hair loss.
  • The clinical hold was not unexpected since the FDA had previously informed the company that it needed to review the toxicology data before proceeding. The agency has 30 days from the receipt of Concert's response to notify the company whether the clinical hold is lifted. No safety concerns have been cited.
  • Shares are off 16% premarket but only on 350 shares.
  • Now read: Editas Medicine's extension of LCA10 IND weighs on shares, down 8%


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