Go or no go? The FDA’s Amylyx dilemma
June will see adcoms aplenty, with Bluebird, Acadia, and the Covid vaccine makers Novavax, Pfizer/Biontech and Moderna all facing FDA committees.
Hit and miss obesity data for Rhythm
The rare disease player plans to submit Imcivree in Bardet-Biedl syndrome next year, but Alström syndrome looks like a no-go.
First-quarter catalysts for the smaller players
Important data releases are on the cards for Rhythm, Wave and Supernus, among others.
Go or no go? Big decisions loom for Bristol and Sanofi
The FDA will have a busy November, with decisions due for Bristol, Sanofi and Y-mabs, among others.
Key biotech catalysts approach
Important clinical data are expected in the fourth quarter from biotech companies including Madrigal, Arena, Rhythm and Forma.
Rhythm hits its obesity endpoints after excluding some patients
Setmelanotide looks approvable, but patients were stratified for inclusion in some measures.
Upcoming events – Pivotal data readouts for Ardelyx and Rhythm will set the tone for next year
Both Ardelyx and Rhythm Pharmaceuticals are looking for phase III clinical wins to kick off filing discussions for pipeline leads.