AveX­is shares soar af­ter it out­lines FDA’s sup­port for a loom­ing piv­otal study on SMA

Shares of AveX­is $AVXS ripped high­er af­ter the mar­ket close on Tues­day af­ter the gene ther­a­py biotech out­lined the FDA’s ac­cep­tance of a small, sin­gle arm piv­otal study for rare cas­es of spinal mus­cu­lar at­ro­phy Type 1 (SMA).

Ac­cord­ing to the Chica­go-based biotech, reg­u­la­tors signed off on a 20-pa­tient study that would use a his­tor­i­cal com­par­i­son for eval­u­at­ing ef­fi­ca­cy. And that lays a straight path to a piv­otal study now slat­ed to be­gin in the first half of a loom­ing 2017.

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.