Paion - Filings in the US and Japan in next six months
Assuming a successful FDA review of remimazolam for procedural sedation (PS), with an outcome due by 5 April 2020, Paion is set for 20–25% royalties from US sales made by Cosmo. Remimazolam is a safe ultra-short-acting sedative/anaesthetic offering both rapid onset and offset of action. This profile should drive US market uptake for short, painful procedures such as colonoscopy. A European regulatory filing for PS will now be made in H219 allowing a possible European launch in 2021, and an abbreviated EMA filing for general anaesthesia (GA) could be made by late 2020. We maintain our valuation of €317m (€4.96 per share). Dr James Phillips took over as CEO on 16 October.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.
Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.
.
Unfortunately, this report is not available for the investor type or country you selected.
Browse all ResearchPool reportsReport is subscription only.
Thank you, your report is ready.
Thank you, your report is ready.