Needham downgraded Biogen Inc (NASDAQ:BIIB) on Monday, citing slower-than-expected growth for its Alzheimer's drug, Leqembi, and a lack of major catalysts over the next 12 months.
The CHMP recommended marketing approval for Leqembi as a treatment of adult patients with early Alzheimer’s disease who are apolipoprotein E ε4 (ApoE ε4) non-carriers or heterozygotes with ...
The increase on CDR-SB score was 1.22 for Leqembi and 1.75 for a dummy drug, where higher numbers indicate greater impairment. Leqembi's vial design could result in hundreds of millions in annual ...
The European Medicines Agency's (EMA's) Committee for Medicinal Products for Human Use (CHMP) has recommended granting marketing authorization for Leqembi ... in their CDR-SB score, while those ...
Slightly lower than the last score the phone allegedly managed, but still very impressive. Mind you, as far as we know, AnTuTu never shows 100%, so this is as good as it gets. Just as a reminder ...
The EMA stated: “After re-examining its initial opinion, EMA’s human medicines committee, or CHMP, has recommended granting a marketing authorisation to Leqembi for treating mild cognitive ...
A European Medicines Agency committee had said in July that the medicine, called Leqembi, should be rejected, citing the modest benefits seen in trials and the potentially dangerous side effects ...
A key European regulatory panel has reversed course and is now recommending approval of Leqembi, the Alzheimer's drug from Biogen and Eisai. The companies on Thursday said the European Medicines ...
Raymond James analyst Danielle Brill says the news that the European Medicines Agency’s CHMP reversed course and issued a positive recommendation for the marketing authorization of Leqembi in the EU ...
The European Union’s drugs regulator on Thursday (November 14, 2024) recommended approval of Eisai and Biogen’s Leqembi for some patients with early Alzheimer’s disease, reversing its ...