CHMP issues positive recommendation for approval of lecanemab in the EU
BioAge Labs, Inc. (BIOA)
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Source: PR Newswire
STOCKHOLM, Nov. 14, 2024 /PRNewswire/ -- BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation regarding BioArctic's partner Eisai's marketing authorization application (MAA) for lecanemab as treatment of Alzheimer's disease. The recommendation applies to the treatment of early Alzheimer's disease in adult patients that are apolipoprotein E e4 (ApoE e4) heterozygotes or non-carriers. The CHMP recommendation for the European Commission to approve lecanemab follows Eisai's request for a re-examination of the CHMP's earlier negative recommendation. A decision from the European Commission is expected within 67 days.The CHMP recommends approval of lecanemab for the treatment of mild cognitive impairment (MCI) and mild dementia caused by Alzheimer's disease, in adult patients who are heterozygotes (carry one copy) or are non-carriers of the Apolipoprotein E e4 (ApoE e4) gene."We a
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News
- BioAge Labs to Present at Upcoming Investor ConferencesGlobeNewswire
- CHMP issues positive recommendation for approval of lecanemab in the EUPR Newswire
- BioAge Labs Reports Strong Q3 2024 Achievements [Yahoo! Finance]Yahoo! Finance
- Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billionPR Newswire
- Eisai updates Leqembi® outlook for fiscal year 2024 (April 2024 - March 2025). Sales now expected to reach JPY 42.5 billionPR Newswire
BIOA
Sec Filings
- 11/14/24 - Form SC
- 11/12/24 - Form SC
- 11/7/24 - Form 10-Q
- BIOA's page on the SEC website