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BioArctic AB's partner Eisai has received approval from Mexico's COFEPRIS for Leqembi (lecanemab) to treat early Alzheimer's disease. The drug, which selectively binds to amyloid-beta aggregates, is the first approved treatment proven to reduce disease progression and slow cognitive decline through this mechanism.

The approval is supported by successful results from the Phase 3 Clarity AD clinical trial, where Leqembi met its primary and key secondary endpoints. The drug is already approved in multiple countries including the U.S., Japan, China, and others. In Mexico, approximately 1.3 million people suffer from Alzheimer's disease.

Leqembi was developed through collaboration between BioArctic and Eisai, with BioArctic retaining rights to jointly commercialize in the Nordic region pending European approval.

Hexagon AB has announced that its nomination committee proposes Björn Rosengren as new Vice Chairman of the Board at the Annual General Meeting on May 5, 2025. This move is part of succession planning as current Chairman Ola Rollén has indicated his intention to step down at the 2026 AGM after 26 years on the board. Rosengren, who previously served as CEO of ABB and Sandvik AB, will be positioned to take over the chairmanship. The announcement also notes that board member Brett Watson will not seek re-election in 2025.

Hexagon is a global leader in precision technologies with approximately 24,500 employees across 50 countries and net sales of about 5.4bn EUR.

SimScale and Hexagon's Manufacturing Intelligence division have announced a strategic partnership to deliver advanced structural analysis capabilities through a cloud-native platform. The collaboration integrates Hexagon's Marc nonlinear finite element solver into SimScale's browser-based platform as a Software-as-a-Service (SaaS) solution. This partnership aims to democratize access to advanced simulation tools, enabling engineering teams of all sizes to perform complex structural analyses without requiring extensive technical expertise or specialized IT infrastructure. The platform features live in-product support and has been ranked first in user satisfaction in the Simulation & CAE Software category by G2.

Eisai has launched Leqembi® in South Korea following its approval in May 2024 for treating early Alzheimer's disease (AD). The drug targets approximately 900,000 dementia patients in South Korea, where about 70% have Alzheimer's dementia. Leqembi, developed through collaboration between BioArctic and Eisai, is the first approved treatment that reduces disease progression by targeting amyloid-beta aggregates. The initial launch will be in the private market, with BioArctic retaining rights for joint commercialization in the Nordic region pending European approval.

Hexagon has announced the acquisition of indurad, a German-based leader in radar and Real-Time Location Systems technologies, along with its autonomous haulage subsidiary, xtonomy. The acquisition aims to enhance mine safety through advanced radar-based collision avoidance systems and increase productivity via real-time ore tracking. indurad reported revenues of approximately 19 MEUR in 2023 and has 140 employees globally. The transaction is expected to close in late November, with indurad being consolidated into Hexagon's Autonomous Solutions division. While initially below Hexagon Group levels, profitability is expected to improve as synergies are realized.

BioArctic AB announces that EMA's Committee for Medicinal Products for Human Use (CHMP) has issued a positive recommendation for lecanemab as an Alzheimer's disease treatment in the EU. The recommendation applies to adult patients with early Alzheimer's who are apolipoprotein E ε4 heterozygotes or non-carriers. This follows a re-examination of CHMP's earlier negative recommendation, with European Commission's decision expected within 67 days. Lecanemab is already approved in multiple countries including the US, Japan, and China. BioArctic holds Nordic region commercialization rights, while partner Eisai handles development and commercialization elsewhere.

BioArctic AB announced that its partner Eisai has revised down its revenue forecast for Leqembi for fiscal year 2024 (April 2024-March 2025) to JPY 42.5 billion from JPY 56.5 billion previously announced in May. This adjustment would generate approximately SEK 300M in royalty for BioArctic. First-half FY2024 Leqembi sales reached JPY 16.3 billion, resulting in SEK 112.4M royalty to BioArctic. Eisai leads Leqembi's development and regulatory submissions globally, with Biogen co-commercializing the product. BioArctic maintains Nordic region commercialization rights, pending European approval.

BioArctic AB has unveiled its proprietary BrainTransporter (BT) platform at the PEGS conference in Barcelona. The technology demonstrates up to 70-fold higher penetration of antibodies across the blood-brain barrier using Transferrin Receptor-mediated transport, without negative effects on hematological safety. The platform shows rapid, broad, and deep distribution of amyloid-beta antibodies across the brain in preclinical models. In April 2024, BioArctic and Eisai entered a research evaluation agreement for BAN2802, combining BT technology with an Alzheimer drug candidate.

BioArctic AB (NASDAQ STOCKHOLM: BIOA B) has announced it will release its Q3 2024 report for July-September on November 14, 2024, at 08:00 CET. The company will host an audiocast with teleconference in English at 09:30 CET where CEO Gunilla Osswald and CFO Anders Martin-Löf will present the quarterly results and conduct a Q&A session. Participants can join via webcast or teleconference, with both options requiring pre-registration. The presentation will be available on-demand afterward on BioArctic's corporate website.