PTC shares rocket up as European regulators offer a thumbs-up on Duchenne drug marketing
A few days after warning investors of the rising uncertainty it faced in the ongoing European review of its conditional approval for Translarna, shares of PTC Therapeutics $PTCT skyrocketed this morning after regulators gave it a thumbs up on keeping the controversial Duchenne drug on the market.
There is a condition attached to the recommendation from the Committee for Medicinal Products for Human Use. The CHMP wants PTC to conduct a placebo-controlled, 18-month study of their drug followed by an 18-month extension study, with data expected in early 2021. That would give them a clear marketing runway of close to 5 more years, if the EMA formerly accepts the recommendation.
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