Immunogen and Uniqure are also set for Pdufa conclusions.
Big regulatory events for July include a panel for Fibrogen's roxadustat and decision time for Albireo; elsewhere, Jak inhibitor delays could persist.
April will see the US regulator examine Pfizer’s Jak in atopic dermatitis, and experts meet to discuss accelerated approvals in oncology.
A win with a tenapanor combo could bode well for the project’s monotherapy chances.
The Danish group tops the list, while Ardelyx could get its first nod for tenapanor, and Xeris gets a second shot with its hypoglycaemia rescue pen.