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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.

Barnes Group Inc. (NYSE: B) reported Q2 2024 financial results, showing sales of $382 million, up 13% year-over-year with organic growth of 5%. The company recorded an operating loss of $2.1 million due to a $53.7 million non-cash impairment charge in the Automation business unit. Adjusted operating income was $47.6 million, up 9%, with adjusted operating margin at 12.4%, down 40 bps. Adjusted EBITDA was $76.5 million, up 14%, with a margin of 20.0%, up 20 bps. Barnes reported a net loss of $46.8 million, or -$0.91 per share, compared to net income of $17.4 million, or $0.34 per share in the prior year. Adjusted EPS was $0.37, down 36% from $0.58 last year. The company updated its 2024 guidance, projecting organic sales growth of 4% to 6% and adjusted EPS of $1.55 to $1.75.

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.

Barnes Aerospace's Taoyuan, Taiwan site has received MTU Maintenance Hannover GmbH's Number One Supplier Award for the second consecutive six-month evaluation period. The award, presented during a May 2024 supplier recognition ceremony, is based on MTU's Supplier Evaluation Tool (SET) which assesses key performance indicators including turnaround time, quality, and reliability.

MTU Maintenance Hannover GmbH's Manager of Customer Accounts, Markus Breuer, praised Barnes Aerospace's customer service team for their dedication and capability in developing and industrializing repairs. Johnson Hsu, General Manager of Barnes Aerospace–Taoyuan, noted that MTU has grown with them by more than 300% in the last five years. The award underscores Barnes Aerospace's commitment to operational excellence and outstanding customer support.

Barnes Group Inc. (NYSE: B) has announced a quarterly cash dividend of $0.16 per share, payable on September 10, 2024, to shareholders of record as of August 22, 2024. This declaration continues Barnes' long-standing tradition of dividend payments, which has been maintained by the company and its predecessors since 1934. The consistent dividend payout demonstrates Barnes' commitment to providing regular returns to its shareholders and reflects the company's financial stability.

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.