Company Spotlight: Versartis

(RTTNews) - Shares of Versartis Inc. (VSAR) have gained more than 20% in the last three trading days. The company's flagship product candidate is Somavaratan, a long-acting form of recombinant human growth hormone for the treatment of growth hormone deficiency, or GHD.

A phase III trial of Somavaratan in pediatric GHD, dubbed VELOCITY, is underway. Enrollment in the trial, which is being conducted in the U.S., Europe and Canada, was completed last August - achieving the target of 137 patients. The primary endpoint of the trial is height velocity at 12 months. Data from this trial are expected to be reported in September of this year.

Another phase III trial of Somavaratan in pre-pubertal Japanese children with growth hormone deficiency is also ongoing, and it is known by the name J14VR5 trial. Enrollment in this trial is expected to be completed during the second half of this year.

Also of note is a long term safety study of Somavaratan for pediatric GHD. This study, known as VISTA, is open to to pediatric patients completing a Somavaratan study in growth hormone deficiency, as well as new pediatric patients with GHD. This trial is being conducted in the United States, Canada and Europe.

Versartis plans to evaluate pediatric patients switching from daily recombinant human growth hormones (rhGH) like Genotropin and Norditropin to twice-monthly Somavaratan. The study, known as PGHD "Switch" Study, is planned for initiation in the first half of 2017.

Somavaratan has also been tested in adults with GHD in a phase II trial. This study, known as VITAL, has helped the company identify a clear path for phase III trial of Somavaratan in adult GHD. Versartis is planning to initiate a phase III trial of Somavaratan in adult GHD by the end of 2017.

Key Financial Data...

-- Net loss widened to $95.8Mln or $3.11 per share in 2016 from $82.17Mln or $2.84 per share in 2015. -- Cash on hand at December 31, 2016: $201.2 million.

VSAR touched a 52-week high of $21.15 on Thursday (Feb.23) before closing the day's trading at $21.10, up 8.21%.