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BioAge Labs, Inc. - BIOA STOCK NEWS

Welcome to our dedicated page for BioAge Labs news (Ticker: BIOA), a resource for investors and traders seeking the latest updates and insights on BioAge Labs stock.

BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) is a Swedish research-based biopharmaceutical company that focuses on developing innovative treatments to slow or halt the progression of neurodegenerative diseases. Founded by Professor Lars Lannfelt, the company is renowned for its groundbreaking work in Alzheimer's disease, particularly with the development of Leqembi® (lecanemab), the world's first drug proven to slow cognitive decline in early Alzheimer's disease patients.

BioArctic operates through strategic alliances, with a significant partnership with Eisai, a global pharmaceutical company. Together, they developed lecanemab, a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ). Lecanemab has been granted approval in the U.S., Japan, China, and South Korea, with pending applications in several other countries including the European Union and Canada. The drug's efficacy was demonstrated in the Phase 3 Clarity AD study, which met all primary and key secondary endpoints with statistically significant results.

Recently, BioArctic and Eisai presented new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases, showcasing its binding properties and lower incidence of adverse events compared to other antibodies. This data reinforces the importance of early diagnosis and treatment in managing Alzheimer's disease.

In addition to Alzheimer's research, BioArctic's portfolio includes antibodies targeting Parkinson's disease and ALS. They employ their proprietary BrainTransporter™ technology, which enhances the delivery of therapeutic antibodies across the blood-brain barrier, potentially increasing the efficacy of treatments.

BioArctic is also committed to sustainable innovation and has integrated environmental, social, and corporate governance principles into its operations, recently earning a place on the Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index. This recognition underscores the company's dedication to responsible business practices and the positive societal impact of its research and development activities.

Financially, BioArctic benefits from royalty payments related to lecanemab sales and milestone payments tied to regulatory approvals. In the first quarter of 2024, Leqembi generated JPY 2.83 billion in sales, resulting in SEK 18 million in royalties for BioArctic, with projections for significant revenue growth in the coming year.

News

BioArctic and Eisai sign research evaluation agreement regarding BAN2802

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BioArctic and Eisai have signed a research evaluation agreement for BAN2802, a potential Alzheimer's treatment combining BrainTransporter™ technology with an undisclosed drug candidate. The collaboration aims to develop the next generation disease-modifying treatment for Alzheimer's disease. Eisai will evaluate the data to potentially license BAN2802, building on their successful partnership that led to the approval of Leqembi® for early Alzheimer's disease.
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The Nomination Committee's proposal for the election of Board members and Chairperson of the Board in BioArctic AB

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BioArctic AB's Nomination Committee proposes the election of board members and Chairperson for the upcoming Annual General Meeting. The proposed board consists of seven members, including a new member, Anna-Lena Engwall, with extensive experience in the life science and pharmaceutical industry. The Nomination Committee aims to enhance the board's expertise and network through these appointments.
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BioArctic's focus on Sustainable Innovation qualifies company for new ESG Responsibility Index at Nasdaq Stockholm

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BioArctic AB (NASDAQ: BIOA-B) included in Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index for its Sustainable Innovation approach. The company focuses on developing safe drugs against neurodegenerative diseases while integrating economic and environmental sustainability.
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Submission of Leqembi® (lecanemab-irmb) sBLA for IV maintenance dosing for the treatment of early Alzheimer's disease to the U.S. FDA completed

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Eisai submits sBLA for monthly IV maintenance dosing of Leqembi for Alzheimer's disease treatment. The application is based on Phase 2b and Clarity AD studies data. Fast Track designation sought for SC formulation.
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Lecanemab deliberations at the CHMP regarding the Marketing Authorisation Application in the EU have been rescheduled due to procedural reasons

Rhea-AI Summary
BioArctic AB's partner Eisai faces procedural delays at EMA for lecanemab review, impacting SAG-N meeting. The decision does not affect the Marketing Authorisation Application for lecanemab. BioArctic and Eisai collaborate on lecanemab development, with BioArctic having commercialization rights in the Nordic region.
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BioArctic: New data on lecanemab presented at the 2024 AD/PD™ congress

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BioArctic AB and Eisai present new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases. The data highlights the efficacy and safety of lecanemab in treating Alzheimer's disease, showing promising results in reducing Aβ protofibrils and plaques in the brain. The collaboration between BioArctic and Eisai has been instrumental in the development and regulatory submissions of lecanemab.
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BioArctic's partner Eisai presents updated sales simulation for Leqembi® at its annual press conference

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BioArctic AB's partner Eisai projects significant sales growth for Leqembi, an Alzheimer's disease treatment, with sales expected to reach JPY 290 billion in FY2026 and JPY 1.6 trillion in FY2032.
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The European Medicines Agency's Scientific Advisory Group (SAG) to discuss the Marketing Authorisation Application for lecanemab: BioArctic

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BioArctic AB (Nasdaq Stockholm: BIOA B) partner Eisai's Scientific Advisory Group (SAG) to discuss lecanemab's Marketing Authorisation Application (MAA) with the European Medicines Agency (EMA) in Q1 2024. Eisai expects European Commission's decision in Q2 2024.
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Leqembi® approved for the treatment of Alzheimer's disease in China

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BioArctic AB's (Nasdaq Stockholm: BIOA B) partner Eisai announced that Leqembi has been approved in China as a treatment for mild cognitive impairment and mild AD dementia due to Alzheimer's disease. Leqembi is the first approved treatment shown to reduce the rate of disease progression and slow cognitive and functional decline. The drug is based on the large global Phase 3 Clarity AD study, where it met its primary endpoint and all key secondary endpoints with statistically significant results. Eisai estimates that there are 17 million patients with MCI or mild dementia due to AD in China today, which is expected to increase with the aging of the population. BioArctic has a long-term collaboration with Eisai regarding the development and commercialization for Leqembi. Eisai is responsible for the clinical development, applications for market approval, and commercialization of the drug. BioArctic has no development costs for Leqembi in Alzheimer's disease and is entitled to payments in connection with certain regulatory approvals, and sales milestones as well as royalties on global sales.
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LEQEMBI® to be launched in Japan for Alzheimer's disease on December 20

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BioArctic AB's (Nasdaq Stockholm: BIOA B) partner Eisai announced the launch of LEQEMBI in Japan on December 20, following its inclusion in the price listing on the Japan National Health Insurance drug price list. The product obtained approval for the indication of slowing progression of mild cognitive impairment and mild dementia due to Alzheimer's disease in Japan on September 25, 2023. LEQEMBI selectively binds to soluble and insoluble amyloid-beta aggregates, reducing Aβ protofibrils and plaques in the brain. The launch in Japan makes it the second country to have the product on the market, following the U.S.
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FAQ

What is the current stock price of BioAge Labs (BIOA)?

The current stock price of BioAge Labs (BIOA) is $6.08 as of December 24, 2024.

What is the market cap of BioAge Labs (BIOA)?

The market cap of BioAge Labs (BIOA) is approximately 218.0M.

What is BioArctic AB known for?

BioArctic AB is known for developing innovative treatments for neurodegenerative diseases, particularly Alzheimer's disease. They created Leqembi®, the first drug proven to slow cognitive decline in early Alzheimer's patients.

Who are BioArctic's main partners?

BioArctic's main partner is Eisai, a global pharmaceutical company. Together, they developed the Alzheimer's drug lecanemab.

What is Leqembi® (lecanemab)?

Leqembi® (lecanemab) is a monoclonal antibody targeting amyloid-beta (Aβ) protofibrils to treat Alzheimer's disease. It is approved in the U.S., Japan, China, and South Korea.

How does BioArctic's BrainTransporter™ technology work?

BioArctic's BrainTransporter™ technology enhances the delivery of therapeutic antibodies across the blood-brain barrier, potentially increasing the efficacy of treatments for neurodegenerative diseases.

What recent achievements has BioArctic made?

BioArctic has recently presented new data on lecanemab at the 2024 International Conference on Alzheimer's and Parkinson's Diseases, showcasing its efficacy and lower incidence of adverse events.

What is BioArctic's commitment to sustainability?

BioArctic is committed to sustainable innovation, integrating environmental, social, and corporate governance principles, earning a place on the Nasdaq OMX Sweden Small Cap 30 ESG Responsibility Index.

What are BioArctic's financial highlights?

In the first quarter of 2024, Leqembi sales generated JPY 2.83 billion, resulting in SEK 18 million in royalties for BioArctic. The company projects significant revenue growth in the coming year.

What are BioArctic's future projects?

BioArctic is involved in research projects targeting Parkinson's disease, ALS, and other Alzheimer's treatments, utilizing their proprietary BrainTransporter™ technology.

How does lecanemab work?

Lecanemab targets aggregated soluble and insoluble forms of amyloid-beta (Aβ), helping to clear Aβ protofibrils and plaques from the brain, thereby slowing cognitive decline in early Alzheimer's patients.

What regulatory approvals does lecanemab have?

Lecanemab is approved in the U.S., Japan, China, and South Korea, with pending applications in the EU, Australia, Brazil, Canada, and several other countries.

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BioAge Labs, Inc.

Nasdaq:BIOA

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6.16%
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