Versartis gets out from under the FDA with its growth hormone treatment

Versartis CEO Jay Shepard

Versartis ($VSAR) has cleared a roadblock in its path to launching a long-acting treatment for growth hormone deficiency, resolving an FDA clinical hold and getting back on track with its Phase III program.

The agency stepped in on Versartis' late-stage trial of VRS-317 in May, halting enrollment and requesting "additional bioanalytical data," the company said at the time. The hold forced Versartis to push back its expected timeline by about 6 months and sent the biotech's shares down more than 10%.

But the Menlo Park, CA, company has since satisfied regulators, getting the green light to resume enrollment in its trial on children with growth hormone deficiency. Versartis now expects to read out interim 6-month efficacy data by the end of 2016 and top-line 12-month results by the middle of 2017. If all goes according to plan, Versartis will be set to submit VRS-317 thereafter, lining up for a 2018 approval.

Versartis pulled off a $126 million IPO last year on the potential for the twice-a-month VRS-317 to disrupt the roughly $3 billion market for growth hormone deficiency treatments, currently dominated by daily injections. Despite the clinical delay, Versartis still expects its lead candidate to become the first and longest-acting human growth hormone product available if and when it wins approval, CEO Jay Shepard said.

The company's shares rose about 13% on the news Monday.

Beyond its aspirations in pediatric growth hormone deficiency, Versartis is plotting a Phase II VRS-317 trial in adults with the disease, and the company has identified a handful of height disorders in which the treatment may have potential.

- read the statement

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