- Following an oral explanation held at the November meeting of the EMA’s human medicines committee, Biogen Inc (NASDAQ:BIIB) received “a negative trend vote” on its marketing application for its controversial Alzheimer’s drug aducanumab.
- “While we are disappointed with the trend vote, we strongly believe in the strength of our data and that aducanumab has the potential to make a positive and meaningful difference for people and families affected by Alzheimer’s disease,” said Priya Singhal, head of global safety & regulatory sciences and interim head of R&D at Biogen.
- The CHMP is expected to adopt a formal opinion on the Marketing Authorization Application at its December meeting, Biogen said.
- Recently, Biogen announced new Phase 3 findings that provide further evidence of aducanumab’s effect on lowering amyloid-beta plaque and downstream tau pathology.
- Price Action: BIIB shares are down 1.74% at $257 during the market session on the last check Wednesday.
Earnings Scheduled For February 18, 2022
Companies Reporting Before The Bell
• DraftKings (NASDAQ:DKNG) is likely to report quarterly loss at $0.79 per share on revenue of $445.18 million.
