Nov. 29 Quick Takes: First TYK2 inhibitor to market on horizon?

Deucravacitinib from Bristol Myers Squibb Co. (NYSE:BMY) could become the first TYK2 inhibitor to be granted regulatory approval after FDA and EMA respectively accepted NDA and MAA submissions. Bristol is seeking approval for adults with moderate-to-severe plaque psoriasis based on Phase III data demonstrating superiority to both placebo and Otezla apremilast from Amgen Inc. (NASDAQ:AMGN). The two new filings follow an NDA acceptance by Japan’s Ministry of Health, Labour and Welfare for deucravacitinib to treat to severe plaque psoriasis, pustular psoriasis and erythrodermic psoriasis. FDA has set a PDUFA date of Sept. 10, 2022. Deucravacitinib is in development for at least four additional diseases, though recently missed its efficacy endpoint in a Phase II study to treat ulcerative colitis. 

NRx Pharmaceuticals Inc. (NASDAQ:NRXP) will pursue an EUA and breakthrough therapy designation for Zyesami aviptadil after a post-hoc analysis of data obtained in a study of critically ill COVID-19 patients unresponsive to Veklury remdesivir showed that it increased the odds of being alive and free of respiratory failure 2.5-fold (p=0.03) at day 60, compared with placebo. The company’s stock rose $1.35 (20%) to $8.10 Monday. NRx conducted the analysis in response to FDA’s Nov. 4 denial of EUA and breakthrough therapy designation for Zyesami to treat COVID-19 patients more broadly, and the agency’s request for additional clinical data comparing Zyesami and Veklury. Zyesami is an injectable synthetic formulation of human vasoactive intestinal peptide that is not FDA-approved for any indication. ...