Sarep­ta was stunned by the re­jec­tion of Vyondys 53. Now it's stun­ning every­one with a sur­prise ac­cel­er­at­ed ap­proval

Sarep­ta has a friend in the FDA af­ter all. Four months af­ter the agency de­ter­mined that it would be wrong to give Sarep­ta an ac­cel­er­at­ed ap­proval for their Duchenne MD drug golodirsen, reg­u­la­tors have ex­e­cut­ed a stun­ning about face and of­fered the biotech a quick green light in any case.

It was the agency that first put out the news late Thurs­day, an­nounc­ing that Duchenne MD pa­tients with a mu­ta­tion amenable to ex­on 53 skip­ping will now have their first tar­get­ed treat­ment: Vyondys 53, or golodirsen. Hav­ing se­cured the OK via a dis­pute res­o­lu­tion mech­a­nism, the biotech said the new drug has been priced on par with their on­ly oth­er mar­ket­ed drug, Ex­ondys 51 — which for an av­er­age pa­tient costs about $300,000 per year, but since pric­ing is based on weight, that stick­er price can even cross $1 mil­lion.

Sarep­ta shares $SRPT surged 23% af­ter-mar­ket to $124.

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