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.
Both Ardelyx and Rhythm Pharmaceuticals are looking for phase III clinical wins to kick off filing discussions for pipeline leads.
Intercept Pharmaceuticals and the whole Nash field await Ocaliva’s pivotal readout.