Vanda withdraws Marketing Authorization Application for Fanaptum in EU Vanda Pharmaceuticals announced that it has withdrawn its Marketing Authorization Application submitted to the European Medicines Agency's Committee for Medicinal Products for Human Use for Fanaptum for the treatment of adult patients with schizophrenia. This withdrawal is based on a request by the CHMP/Rapporteur/Co-rapporteur for Vanda 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. Vanda intends to reassess its European regulatory strategy for Fanaptum once the results from the Relapse Prevention Study in Patients with Schizophrenia become available.
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Vanda pullback a buying opportunity, says Piper Jaffray Piper Jaffray recommends using the post-earnings pullback in shares of Vanda Pharmaceuticals as a buying opportunity. Piper says Hetlioz is launching well and that it sees no reason to back off its bullish stance or $25 price target. The firm reiterates an Overweight rating on the name.