PDU­FA date past, PTC still hasn’t said what the FDA’s ver­dict was; BioIn­vent search­ing for a new CEO

→ So what’s hap­pen­ing with PTC Ther­a­peu­tics? The PDU­FA date for its Duchenne mus­cu­lar dy­s­tro­phy drug ataluren came and went yes­ter­day with­out a peep from the com­pa­ny. A spokesper­son for the com­pa­ny tells me to­day that they’ll pro­vide an up­date when pos­si­ble, but there’s no of­fi­cial word what the FDA’s de­ci­sion was. The biotech $PTCT forced the agency to re­view their drug af­ter it was slapped down twice af­ter reg­u­la­tors con­clud­ed that the com­pa­ny had nev­er sub­mit­ted an ad­e­quate ap­pli­ca­tion for the drug. An ex­pert pan­el vot­ed 10 to 1 that the da­ta avail­able were still in­con­clu­sive.

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.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER