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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 that Australia's Therapeutic Goods Administration (TGA) initially decided not to register lecanemab, an antibody for treating mild cognitive impairment and mild dementia due to Alzheimer's disease. Eisai plans to request reconsideration within 90 days, with TGA's final decision expected 60 days after. Lecanemab, developed through BioArctic and Eisai's collaboration, is already approved in several countries including the US, Japan, and China.
The antibody originated from BioArctic's research based on Professor Lars Lannfelt's work. Eisai leads global development and regulatory submissions, with Eisai and Biogen co-commercializing the product. BioArctic retains commercialization rights in the Nordic region and is preparing for joint commercialization with Eisai in Europe, pending approval.
BioAge Labs (Nasdaq: BIOA) has successfully closed its upsized initial public offering (IPO) of 12,650,000 common stock shares at $18.00 per share, including the full exercise of the underwriters' option for 1,650,000 additional shares. The company also completed a concurrent private placement of 588,888 shares at the IPO price to an existing stockholder. The combined gross proceeds from the IPO and private placement totaled approximately $238.3 million, before deducting underwriting discounts, commissions, and expenses.
Goldman Sachs & Co. , Morgan Stanley, Jefferies, and Citigroup served as joint book-running managers for the offering and placement agents for the private placement. The IPO shares were offered under registration statements filed with the SEC, which became effective on September 25, 2024.
BioAge Labs, a clinical-stage biopharmaceutical company focusing on metabolic diseases, has announced the pricing of its upsized initial public offering (IPO). The company is offering 11,000,000 shares of common stock at $18.00 per share, expecting to raise $198.0 million in gross proceeds. Trading is set to begin on September 26, 2024, on the Nasdaq Global Select Market under the ticker symbol 'BIOA'.
The offering is expected to close on September 27, 2024. BioAge has also granted underwriters a 30-day option to purchase up to an additional 1,650,000 shares. Goldman Sachs & Co. , Morgan Stanley, Jefferies, and Citigroup are acting as joint book-running managers for the offering.
BioArctic AB (Nasdaq Stockholm: BIOA B) has announced the publication of results from two phase 1 studies of exidavnemab in The Journal of Clinical Pharmacology. Exidavnemab is a monoclonal antibody targeting aggregated forms of α-synuclein, aimed at treating diseases like Parkinson's disease. The studies, conducted with AbbVie, involved 98 healthy volunteers, with 85 receiving exidavnemab. Results showed that exidavnemab was generally well-tolerated with an excellent half-life of approximately 30 days. The drug's high affinity and selectivity toward pathological α-synuclein aggregates are key for maintaining high target binding in the brain. CEO Gunilla Osswald expressed anticipation for starting the phase 2a study later this year.
BioArctic AB announced that its partner Eisai received Marketing Authorization from the MHRA in Great Britain for Leqembi (lecanemab) to treat mild cognitive impairment and mild dementia due to Alzheimer's disease in specific adult patients. This marks the first authorization in Europe for a medicine targeting an underlying cause of Alzheimer's disease.
Lecanemab selectively binds to and clears toxic Aβ protofibrils from the brain. The approval was based on the Phase 3 Clarity AD clinical trial, which met its primary and key secondary endpoints. Common adverse reactions include infusion-related reactions and amyloid-related imaging abnormalities.
Eisai is working with health authorities to make Leqembi available to eligible patients. The antibody was originally developed by BioArctic, resulting from a collaboration with Eisai.
BioArctic AB (NASDAQ Stockholm: BIOA B) has addressed recent rumors circulating in British media regarding the imminent approval of lecanemab in Great Britain. The company stated that it has not been informed of any decision made by the relevant authorities and is therefore unable to comment on these speculations. BioArctic has committed to updating the market if new information becomes available. This statement was released for public disclosure on August 22, 2024, at 08:34 a.m. CET. The company has provided contact information for its VP of Communications and IR, Oskar Bosson, for further inquiries.
BioArctic AB (NASDAQ Stockholm: BIOA B) has announced the upcoming release of its second quarter report for April - June 2024 on August 29, 2024, at 08:00 a.m. CET. Following the report's publication, the company will host an audiocast with teleconference at 09:30 CET on the same day. CEO Gunilla Osswald and CFO Anders Martin-Löf will present and discuss the quarterly results, followed by a Q&A session. Investors, analysts, and media are invited to participate via webcast or teleconference. The webcast will be available on-demand on BioArctic's corporate website after the presentation.
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.
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