Shares of PTC Therapeutics, Inc. (PTCT) are declining more than 34 percent on Friday morning trade after the Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency has given a negative opinion to its conditional authorization and full marketing authorization of Translarna for the treatment of nonsense mutation Duchenne muscular dystrophy.
PTC plans to submit a request for re-examination per EMA guidelines. Translarna will remain on the market and available to patients with nmDMD until the re-examination process is completed.
The company said it is "surprised and extremely disappointed" by the CHMP decision.
Translarna had received conditional marketing authorization in Europe in 2014. The re-examination process would be expected to occur in January 2024, with EC ratification of the opinion within the following 67 days.
Currently, shares are at $24.63, down 34.13 percent from the previous close off $37.39 on a volume of 2,269,543.
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