Graduate 1 and 2 data are “not yet in house”, but a pooled analysis beckons in the event of one study failing.
A November adcom could decide whether Zejula will lose yet more ground to Lynparza.
Relmada, Albireo and Mirum prepare for important clinical results, as Intercept is set back again.
Amicus and Astrazeneca have notable approaching Pdufa decisions, while a panel for GSK’s daprodustat could change the course of a controversial drug class.
Important data reveals are expected from Madrigal, Arrowhead and Ascendis, with details from Biogen and Eisai due at a conference.
Merck & Co and Novartis are set for important disclosures as Roche battles with Biogen and Eisai in Alzheimer’s.
It is make or break time for the smaller group’s TL1A inhibitor PRA023.
A green light from the FDA is expected for deucravacitinib, while Amylyx, Ferring and Oncopeptides head for panels.
Pdufa decisions also beckon for Amicus, Acadia and Bluebird.