Versartis rises after FDA removes clinical hold

Versartis Inc. (NASDAQ:VSAR) gained $4.30 (29%) to $18.92 on Monday after FDA lifted a partial clinical hold on the Phase III VELOCITY study of VRS-317, a long-acting recombinant human growth hormone (rhGH) to treat growth hormone deficiency (GHD). In May, FDA suspended enrollment of the trial and requested additional bioanalytical data from the company.

VELOCITY's primary endpoint is non-inferiority in mean height velocity among patients receiving semi-monthly VRS-317 vs. daily rhGH treatment in treatment-naive children. Versartis expects interim results by YE16 and top-line 12-month results on the primary endpoint by mid-2017. ...