Biogen Partner Eisai Gets Positive CHMP Nod for Leqembi in Europe [Yahoo! Finance]
Biogen Inc. (BIIB)
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Source: Yahoo! Finance
Use (CHMP) has rendered a positive opinion recommending marketing approval for Leqembi (lecanemab) for early Alzheimer's disease. The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer's disease who are apolipoprotein E e4 (ApoE e4) non-carriers or heterozygotes with confirmed amyloid pathology in Europe. A final decision from the European Commission is expected within 67 days of receipt of the CHMP opinion. Shares of Biogen have plunged 36.3% year to date compared with the industry's decline of 4.5%. Image Source: Zacks Investment Research The CHMP had earlier given a negative opinion regarding marketing approval for Leqembi for early Alzheimer's disease in July 2024. The negative opinion was reportedly due to a brain swelling side effect called amyloid-related imaging abnormalities associated with the use of anti-amyloid therapies like Leqembi. Eisai requested the CHMP to re-examine its opinion. Leqembi gained full app
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BIIB
Earnings
- 10/31/24 - Beat
BIIB
Sec Filings
- 11/12/24 - Form SC
- 11/7/24 - Form 4
- 11/4/24 - Form 4
- BIIB's page on the SEC website