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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.
BioArctic AB's partner Eisai announced the approval of Leqembi (lecanemab) for the treatment of Alzheimer's disease in the United Arab Emirates (UAE). The approval is based on the successful Phase 3 Clarity AD study, where Leqembi met its primary and key secondary endpoints. Leqembi is the first approved treatment shown to reduce disease progression and slow cognitive decline by targeting amyloid-beta aggregates in the brain.
In the UAE, 4.09% of those over 60 have dementia, with Alzheimer's being the most common cause. Leqembi is already approved in several countries, including the U.S., Japan, and China. The antibody was originally developed by BioArctic, based on research by Professor Lars Lannfelt. Eisai is responsible for clinical development and commercialization, with Biogen commercializing in the UAE.
BioArctic AB's partner Eisai reported that Leqembi® revenue more than doubled in Q2 2024, reaching JPY 6.3 billion, a 120% increase from Q1 2024 (JPY 2.8 billion). This resulted in a royalty of approximately SEK 43 million for BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Eisai and Biogen co-commercializing the product. BioArctic has commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai pending European approval. BioArctic's Q2 2024 report will be published on August 29, 2024, at 08:00 a.m. CET.
BioArctic AB's partner Eisai presented three-year data for lecanemab (Leqembi®) at the Alzheimer's Association International Conference 2024. Key findings include:
1. Increased patient benefit: Lecanemab reduced clinical decline by -0.95 on the CDR-SB scale after three years, up from -0.45 at 18 months.
2. Maintained safety profile: No new safety concerns observed over three years.
3. Early-stage patient improvement: 51% of patients with no or low tau showed improvement after three years.
4. Continued biomarker impact: Lecanemab positively affects biomarkers throughout treatment.
5. Tau spread reduction: Treatment slowed tau accumulation across brain regions.
These results suggest lecanemab's potential as a disease-modifying treatment for early Alzheimer's disease, with increasing benefits over time.
BioArctic AB's partner Eisai announced plans to request re-examination of the Committee for Medicinal Products for Human Use (CHMP)'s negative opinion on the Marketing Authorization Approval for lecanemab, an Alzheimer's disease treatment, in the EU. The decision disappoints BioArctic's CEO, Gunilla Osswald, who emphasizes the importance of timely treatment for patients. Eisai has a 60-day period to provide grounds for re-examination, with CHMP having 60 days to respond.
Lecanemab is already approved in several countries, including the US, Japan, and China. Alzheimer's disease affects 6.9 million people in Europe, with projections indicating this number may double by 2050. BioArctic retains commercialization rights in the Nordic region, pending European approval.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a negative opinion on BioArctic AB's partner Eisai's Marketing Authorization Approval (MAA) for lecanemab, a treatment for Alzheimer's disease. This decision affects BioArctic's (Nasdaq Stockholm: BIOA B) potential to commercialize lecanemab in the Nordic region, which was contingent on European approval.
Lecanemab is already approved and marketed in several countries, including the United States, Japan, and China. BioArctic is consulting with Eisai regarding future actions and will provide an update later today. The negative opinion from CHMP represents a significant setback for BioArctic's European market plans for lecanemab in Alzheimer's disease treatment.
BioArctic AB announced that its partner Eisai will present new data on lecanemab (Leqembi®) at the Alzheimer's Association International Conference (AAIC) 2024. Key presentations include:
1. Three-year efficacy and safety data from Phase 2 and 3 studies
2. Mechanism of action targeting toxic soluble aggregated amyloid-beta protofibrils
3. Importance of maintenance treatment based on neurodegenerative biomarkers
4. Long-term imaging and fluid biomarkers
5. Evidence supporting continued lecanemab dosing
BioArctic will also present a poster on Nordic healthcare system's readiness for new Alzheimer's treatments. Lecanemab, developed through BioArctic and Eisai's collaboration, entitles BioArctic to milestone payments, 9% royalties on global sales, and Nordic region commercialization rights.
BioArctic's partner Eisai announced that Leqembi® (lecanemab) has been approved for Alzheimer's disease (AD) treatment in Israel. The approval is based on the Phase 3 Clarity AD study, which showed that Leqembi met its primary and secondary endpoints with statistically significant results. Israel is the sixth region to approve Leqembi, following the US, Japan, China, South Korea, and Hong Kong. Leqembi works by selectively binding to amyloid-beta aggregates, reducing plaques in the brain. BioArctic, which developed the antibody, will receive milestone payments, a 9% royalty on global sales, and has the right to commercialize Leqembi in the Nordic region.
BioArctic's partner Eisai announced that the Department of Health in Hong Kong has approved Leqembi (lecanemab) for treating Alzheimer's disease. The approval is based on the successful Phase 3 Clarity AD study, which demonstrated statistically significant results in slowing cognitive decline. Hong Kong is the fifth country to approve Leqembi, following the US, Japan, China, and South Korea. Leqembi targets amyloid-beta aggregates to reduce disease progression. BioArctic will commercialize Leqembi in the Nordic region, pending European approval, and will receive a 9% royalty on global sales.
BioArctic AB's partner Eisai has announced the launch of Leqembi® (lecanemab) in China on June 28, 2024. Approved in January 2024 for treating mild cognitive impairment (MCI) and mild dementia due to Alzheimer's disease (AD), Leqembi is now available in the United States, Japan, and China. Eisai estimates there are 17 million early AD patients in China. The drug will be available in the private market with a 200 mg vial priced at CNY 2,508. A specialized healthcare insurance plan partially covering the drug cost has been introduced. Leqembi, which reduces amyloid-beta (Aβ) plaques in the brain, is the first treatment shown to slow disease progression. BioArctic will receive milestone payments and a 9% royalty on global sales, with plans to commercialize the drug in the Nordic region pending European approval.
The FDA has accepted Eisai's Supplemental Biologics License Application (sBLA) for monthly intravenous (IV) maintenance dosing of Leqembi® (lecanemab-irmb) for early Alzheimer's Disease (AD). A Prescription Drug User Fee Act (PDUFA) action date is set for January 25, 2025. Leqembi is designed to treat patients with mild cognitive impairment or mild dementia. The sBLA is based on data from the Phase 2 Study 201, its open-label extension (OLE), and the Clarity AD study. If approved, the monthly dosing regimen would be less burdensome, aiding long-term treatments. Eisai has also initiated a rolling submission to the FDA for a Leqembi subcutaneous autoinjector for weekly dosing. Leqembi is currently approved in several countries, and BioArctic is entitled to payments and royalties from its sales, with rights to commercialize in the Nordic region pending European approval.
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