Veloxis respectfully begs to differ with FDA

Veloxis Pharmaceuticals A/S (CSE:VELO) plunged DKK0.63 (31%) to DKK1.40 on Friday after the company said FDA's tentative approval of immunosuppressant Envarsus XR tacrolimus will not become finalized until exclusivity expires for Astagraf XL tacrolimus from Astellas Pharma Inc. (Tokyo:4503) on July 19, 2016.

Veloxis President and CEO William Polvino told BioCentury the NDA for once-daily Envarsus XR was submitted through the 505(b)(2) pathway and relied on data for Astellas' twice-daily Prograf tacrolimus, not the pharma's once-daily extended release Astagraf. ...