BioAge Labs Inc. Stock Price, News & Analysis

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.

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.