Shares of Concert Pharmaceuticals (CNCE) were down nearly 10%, or $1.60, to $14.45 after the Food and Drug Administration placed the company's mid-stage study of its CTP-543 in hair loss treatment on clinical hold pending review of non-clinical toxicology studies.
Concert now must submit to the FDA of the non-clinical toxicology studies prior to dosing patients in its Phase 2a study of CTP-543 for the treatment of the autoimmune disorder alopecia areata.
The clinical hold was a surprise because the FDA had previously informed the company that it could initiate the Phase 2a clinical trial. The FDA did not cite a safety concern; however, they intend to review these additional non-clinical data as support for the one-year dosing duration as planned in the Phase 2a trial.
The agency has 30 days from the receipt of Concert's response to notify the company whether the clinical hold is lifted. Concert said it is working diligently with the FDA to resume enrollment in the Phase 2a trial as quickly as possible.
Shares of drug distributor McKesson (MCK) were down $2.39, or 1.65%, to $142.53 as it gears up to report fourth-quarter fiscal 2017 results on Thursday, May 18. Investors have trepidation because McKesson has missed estimates in two of the past four quarters and may fear another "fourth quarter surprise." However, for the third quarter, it delivered better than expected earnings. McKesson's troubles include fewer generic launches, generic price deflation and customer consolidation.
Real Money's Bruce Kamich warns that bears still have the upper hand at McKesson.