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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