Setback for Santhera as partner declares itself unready to proceed

Specialty pharmaceutical company Santhera Pharmaceuticals (SIX: SANN) has announced a delay to the finalization of its New Drug Application (NDA) for vamorolone.

While the clinical module of its rolling NDA for vamorolone in Duchenne muscular dystrophy (DMD) has been submitted, finalization of the official review has been set back by up to six months, the company said.

This is due to a third-party contract manufacturing organization (CMO) requiring more time for “establishing FDA-inspection readiness.”