Next month the FDA will determine Biogen’s fate in Alzheimer’s, while Ascendis and Novo Nordisk also await Pdufa decisions.
May will see US FDA decisions for Apellis, Heron and Bristol Myers Squibb, while Provention Bio is set for a panel meeting.
April will see the US regulator examine Pfizer’s Jak in atopic dermatitis, and experts meet to discuss accelerated approvals in oncology.
Troriluzole has failed in an Alzheimer’s trial, reminding the markets that this is par for the course in this disease.
Early 2021 will see rare diseases dominate for biotech, with Sarepta revealing key data on its gene therapy play.
Amylyx believes it has found a disease-modifying therapy in AMX0035, as other key readouts approach.