Versartis FDA Removes Partial Clinical Hold On Investigational NDA For VRS-317

(RTTNews) - Versartis Inc. (VSAR) said Monday that the US Food and Drug Administration (FDA) has removed the partial clinical hold on the Company's Investigational New Drug Application for VRS-317. With this action, the Company will proceed with the Phase 3 registration trial, VELOCITY, of VRS-317 in children with GHD.

Jay Shepard, Chief Executive Officer, said, "Our team has continued to work diligently with the FDA and we are excited to be moving forward with the Phase 3 clinical trial of VRS-317 in pediatric GHD patients. There is a significant need for these patients to have treatment options that are less burdensome than the daily injections that are the current standard of care. We continue to expect VRS-317 to be the first and longest-acting rhGH product candidate in development to reach the market and, with the removal of the partial clinical hold, we remain on track to achieve this goal."

The company reaffirmed its previously stated anticipated milestones for the VELOCITY Phase 3 clinical trial, including interim 6-month mean height velocity data by the end of 2016 and top line data on the 12-month mean height velocity primary endpoint by mid-2017, enabling a potential Biologics License Application submission, followed by a potential FDA approval by late-2018.