Versartis, Inc. (NASDAQ: VSAR)
Shares of the low float small cap stock VSAR are surging higher in today’s session on news that the FDA has lifted the partial clinical hold on the lead product candidate, VRS-317. This allows VSAR to continue its Phase III trials.
VSAR Back On Track
In May of 2015, the Food and Drug Administration intervened with the company’s VELOCITY study and requested “additional bioanalytical data.” This action by the FDA halted halted enrollment and delayed trials by roughly 6 months.
Since May, the company has worked diligently to satisfy the FDA and has succeeded in appeasing the regulators who have given the all clear to resume the trials on the 317 children with growth hormone deficiencies.
Versartis’ Chief Exececutive Officer, Jay Shepard, noted:
“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.”
Looking ahead, additional data from the VELOCITY trials are expected by the end of 2016 and mid 2017. If all data comes meeting and/or exceeding the milestones, VSAR potentially could have FDA approval sometime in the second half of 2018.
About Versartis, Inc.
Versartis, Inc., incorporated on December 10, 2008, is an endocrine-focused biopharmaceutical company. The Company is engaged in developing long-acting recombinant human growth hormone, VRS-317, for growth hormone deficiency (GHD), an orphan disease. The Company’s products include VRS-317 and XTEN Technology. Reuters