Paion (PA8) - FDA outcome April 2020; EMA filing in Q419

05:54 EDT 15 Aug 2019 | Edison Investment Research

Edison Investment Research - Pharmaceuticals & healthcare - Paion: 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, an abbreviated EMA filing for general anaesthesia (GA) could be made by late 2020. We maintain our valuation of €317m (€4.96 per share).
ISIN: DE000A0B65S3

Original Article: Paion (PA8) - FDA outcome April 2020; EMA filing in Q419


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