FDA DecisionsFDA delayed their decision for a third time and called for an advisory committee, indicating hesitation on the FDA's part regarding the safety profile of donanemab.
Patient UptakeBiogen expects patient uptake for Skyclarys to be 'lumpy' due to adverse events and lack of compliance, which could hinder growth.
Sales PerformanceBiogen's 4Q23 earnings were disappointing, with a miss on the top and bottom lines and weaker-than-expected Leqembi, Skyclarys and Spinraza sales, the most important franchises for the company.