On track for two filings by mid-2018
Paion has completed patient recruitment in its pivotal bronchoscopy study of its ultra-fast-acting sedative remimazolam. Results are likely by mid-2017 and, if positive, would put it on track to file for US approval for procedural sedation in mid-2018. Paion is also preparing a dossier for a filing for general anaesthesia (GA) in Japan in a similar time frame. It has also outlined a programme that could see it restart Phase III studies in GA in Europe (estimated cost €20-25m). Paion has sufficient cash to fund operations beyond end 2018, but would need additional funds to complete the Europe development programme. We leave our valuation unchanged at €214m ahead of the key bronchoscopy trial results.Paion is a holding company. Through its subsidiaries, Co. is a biopharmaceutical company focusing on developing and commercializing drugs to be used in out-patient and hospital-based anesthesia, sedation and critical care services. Co.'s key compound is Remimazolam, an intravenous ultra short-acting and controllable anesthetic/sedative drug candidate in advanced stages of development for use in procedural sedation and general anesthesia.
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