Versartis Inc (NASDAQ:VSAR) is one of the top gainers today, as its shares have soared by nearly 30% in afternoon trading Monday. The huge push for the shares comes after it was announced this morning that the FDA had removed a partial clinical hold on the trial testing of Versartis’ VRS-317, which has set the company back on track to be the first to market with an rhGH (recombinant human growth hormone) treatment for those with growth hormone deficiency (GHD).
“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,” President and Chief Executive Officer Jay Shepard said in a press release announcing the news.
Despite the big gains today, Versartis Inc (NASDAQ:VSAR), which went public back in March of 2014, is still down by more than 15% this year and more than 39% lifetime. Shares of Versartis were particularly hard hit in early May when the company announced the FDA had placed the VRS-317 trial on partial clinical hold as it waited for additional bioanalytical data.
At the time, Versartis expressed that it would attempt to minimize any delays in its trial programs by continuing to recruit participants during that time, with the firm anticipating its enrolment in the phase 3 VELOCITY trial targeting GHD in children would be completed by the middle of 2016, and that 12-month, top line trial data from that study would be available by the middle of 2017. The company reasserted those timelines today, noting that potential FDA approval for its lead drug candidate could be sought as early as late-2018. A separate clinical trial for GHD in adults has completed phase 1 testing.
The latest surge doesn’t seem to have caught hedge funds off guard, who were showing some bullish signs on the company in the first quarter of the year. The number of hedge funds with positions in the company increased to 15 from 10, while the total value of their holdings increased to $187.42 million from $184.55 million, despite shares of Versartis Inc (NASDAQ:VSAR) declining by over 18% during the first quarter. Shares are now up by about 3% since the end of the first quarter.