Vanda Pharmaceuticals, Inc. (VNDA)

[surf1944]

4:09PM Vanda Pharma confirms withdrawal of marketing authorization application for Fanaptum in the European Union (VNDA) 3.80 +0.08 : This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for co to submit the results from an ongoing relapse prevention, randomized iloperidone-placebo withdrawal study in patients with schizophrenia. The results of this study will not be available in the timeframe allowed in the Centralised Procedure. Co intends to reassess its European regulatory strategy for Fanaptum once the results from the Relapse Prevention Study in Patients with Schizophrenia (REPRIEVE) become available.