June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.
The rare disease player plans to submit Imcivree in Bardet-Biedl syndrome next year, but Alström syndrome looks like a no-go.
Important data releases are on the cards for Rhythm, Wave and Supernus, among others.
The FDA will have a busy November, with decisions due for Bristol, Sanofi and Y-mabs, among others.
Important clinical data are expected in the fourth quarter from biotech companies including Madrigal, Arena, Rhythm and Forma.
Setmelanotide looks approvable, but patients were stratified for inclusion in some measures.
Both Ardelyx and Rhythm Pharmaceuticals are looking for phase III clinical wins to kick off filing discussions for pipeline leads.