Yes, the FDA did just slap down PTC’s Duchenne MD drug for the third time

What­ev­er last shred of hope re­mained that PTC could turn things around and win a mir­a­cle ap­proval at the FDA for their Duchenne mus­cu­lar dy­s­tro­phy drug ataluren end­ed with a terse state­ment Wednes­day morn­ing not­ing that the agency has re­ject­ed their mar­ket­ing ap­pli­ca­tion.

Ac­cord­ing to PTC, the FDA has de­mand­ed more da­ta from a new clin­i­cal study, along with some CMC in­put along with ad­di­tion­al in­fo that the biotech says it is in the process of pro­vid­ing.

Endpoints News

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.