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FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer s disease

FDA grants Breakthrough Therapy designation for lecanemab in Alzheimer s disease News provided by Share this article Share this article STOCKHOLM, June 23, 2021 /PRNewswire/ BioArctic AB s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for lecanemab (BAN2401), an investigational anti-amyloid beta (Aβ) protofibril antibody for the treatment of Alzheimer s disease. Breakthrough Therapy designation is an FDA program intended to expedite the development and review of medicines for serious or life-threatening conditions. The benefits of a Breakthrough Therapy designation include more intensive guidance on an efficient development program as well as eligibility for rolling review and potentially priority review.

Veoneer, Inc (VNE) Q1 2021 Earnings Call Transcript

Veoneer, Inc. (VNE) Q1 2021 Earnings Call Transcript Motley Fool Transcribers © The Motley Fool Logo of jester cap with thought bubble. Veoneer, Inc. (NYSE: VNE) Operator Hello and welcome to the Veoneer Q1 Reports 2021. [Operator Instructions] I ll now hand the floor to Thomas Jonsson. Please continue, Jonsson.SPONSORED: 10 stocks we like better than Veoneer, Inc. When investing geniuses David and Tom Gardner have a stock tip, it can pay to listen. After all, the newsletter they have run for over a decade, Motley Fool Stock Advisor, has tripled the market.   David and Tom just revealed what they believe are the ten best stocks for investors to buy right now. and Veoneer, Inc. wasn t one of them! That s right they think these 10 stocks are even better buys.

BioArctic : Lecanemab (BAN2401) Phase 2b study in early Alzheimer s disease published in peer-reviewed journal, Alzheimer s Research & Therapy

Message : Required fields Stockholm April 20, 2021 - BioArctic AB s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer s Research & Therapy. The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer s disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm.

Lecanemab (BAN2401) Phase 2b study in early Alzheimer s disease published in peer-reviewed journal, Alzheimer s Research & Therapy

Share this article Share this article STOCKHOLM, April 20, 2021 /PRNewswire/ BioArctic AB s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced the publication of an article, A Randomized, Double-Blind Phase 2b Proof of Concept Clinical Trial in Early Alzheimer s Disease with Lecanemab, an Anti-Aβ Protofibril Antibody, in the peer-reviewed journal Alzheimer s Research & Therapy.  The manuscript describes results from Study 201, a Phase 2b proof-of-concept study that explored the impact of treatment with lecanemab on reducing brain amyloid beta (Aβ) and clinical decline in patients with early Alzheimer s disease. The manuscript concluded that the analysis showed consistent reduction of clinical decline across several clinical and biomarker endpoints at the highest doses, which the pivotal Phase 3 study Clarity AD aims to confirm. 

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