Versartis Inc. fulfilled its vow to provide the requested "bioanalytical data" to the FDA around the end of this year's second quarter, but still isn't saying exactly what the agency wanted. "We're staying away from it for competitive reasons and other [ones]," CEO Jay Shepard told BioWorld Today.
What matters now is that U.S. regulators have accepted the data and lifted the partial clinical hold (PCH) on VRS-317, allowing the go-ahead with the phase III registrational trial called Velocity in growth hormone deficiency (GHD) in children.
Menlo Park, Calif.-based Versartis' stock (NASDAQ:VSAR) closed Monday at $18.92, up $4.30, or 29.4 percent. "We had an extension trial off our phase II that the FDA let us to continue to enroll,"