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Integrum AB (INTEG B) has announced compelling results from a two-year follow-up study conducted by Walter Reed National Military Medical Center on their OPRA™ Implant System for transfemoral amputees. The Level II Evidence study, focusing on the latest version introduced in 2017, demonstrates significant advantages over traditional socket prostheses.

The study revealed several key achievements:

• 100% implant survival rate
• Reduced infection and complication rates compared to previous data
• Increased prosthetic use
• Improved mobility and quality of life for patients

The research, published in Clinical Orthopaedics and Related Research (CORR), was conducted by a team led by Dr. Benjamin K. Potter and Dr. Jonathan Forsberg. The findings are expected to drive further adoption among US health providers and potentially increase insurance provider reimbursement coverage.

BioArctic AB (Nasdaq Stockholm: BIOA B) has received Orphan Drug Designation from the US FDA for exidavnemab, targeting the treatment of Multiple System Atrophy (MSA). MSA is a rare, fatal disease affecting the central and autonomic nervous systems, characterized by alpha-synuclein aggregation that damages brain nerve cells.

Exidavnemab is being developed as a disease-modifying treatment for synucleinopathies including MSA and Parkinson's disease. As a monoclonal antibody, it selectively targets soluble alpha-synuclein aggregates to potentially reduce their spreading and negative effects.

The FDA's Orphan Drug Designation provides several benefits, including:

• Tax credits for qualified clinical trials
• Prescription drug user-fee exemptions
• Potential seven-year marketing exclusivity upon FDA approval

Hexagon AB has appointed Gordon Dale as President of its Autonomous Solutions (AS) division, reporting to interim President and CEO Norbert Hanke. Dale, a 16-year veteran of Hexagon who joined through the NovAtel acquisition, previously served as Chief Synergy Officer where he successfully integrated the Autonomy & Positioning and Mining businesses into the AS division.

Dale brings significant credentials including an MBA and a Bachelor's in Electrical and Computer Engineering. The appointment follows the completion of AS division's integration, aimed at strengthening Hexagon's growth and margin performance. Hexagon, listed on Nasdaq Stockholm as HEXA B, is a global leader in precision technologies with approximately 24,800 employees across 50 countries and net sales of about 5.4bn EUR.

BioArctic AB (Nasdaq Stockholm: BIOA B) founders Lars Lannfelt and Pär Gellerfors, along with CEO Gunilla Osswald, have been awarded Uppsala University's Innovation and Entrepreneurship Prize 2025 for their groundbreaking work in Alzheimer's disease treatment.

The recognition stems from Lannfelt's 1990s breakthrough in understanding Alzheimer's disease and developing an antibody-based treatment. The company, founded in 2003, partnered with Japanese pharmaceutical company Eisai to develop lecanemab, which is now approved in eleven countries including the USA, Japan, and China, with pending approvals in 17 additional countries and regions, including Europe.

The founders' vision includes building BioArctic into a fully-fledged pharmaceutical company in Sweden, focusing on both research and product commercialization. Gunilla Osswald, CEO since 2014, has been instrumental in realizing this vision of helping patients worldwide.

Hexagon AB (HEXA B) has announced plans to separate its Asset Lifecycle Intelligence (ALI) division and related businesses through a Lex Asea distribution to shareholders, with an expected listing on a U.S. national securities exchange in early 2026. The new company ('NewCo') will include the expanded perimeter of Safety, Infrastructure & Geospatial (SIG) division, ETQ business, and Bricsys business.

NewCo will operate as a standalone software and SaaS company, led by Mattias Stenberg. As of December 31, 2024, NewCo had approximately 7,200 employees and revenues of EUR 1,448 million with an adjusted operating margin of 31%. The remaining Hexagon business will retain approximately 17,600 employees with revenues of EUR 3,953 million and an adjusted operating margin of 29%.

The separation process is subject to stakeholder approval, regulatory consents, and other conditions, with completion targeted for first half of 2026. A temporary Swedish Depository Receipt programme will be established via Nasdaq Stockholm to facilitate the transition.

BioArctic AB (NASDAQ: BIOA B) announced that Australia's Therapeutic Goods Administration (TGA) has declined to approve lecanemab for early Alzheimer's disease treatment. The TGA rejected both the initial application in October 2024 and a December 2024 reconsideration request that proposed limiting the treatment to ApoE4 noncarriers and heterozygotes.

The TGA suggested a narrower indication for ApoE4 noncarriers only, citing safety concerns for ApoE4 heterozygotes. Despite Eisai's proposal for treating heterozygotes in specialist centers under expert supervision, the TGA maintained its rejection.

This decision affects approximately 411,000 people living with dementia in Australia as of 2023, with this number projected to reach 849,000 by 2058. Lecanemab, which works by clearing toxic Aβ protofibrils and plaques, has already received approval in 11 markets including the US, Japan, China, and the UK, with pending applications in the EU and 17 other regions.

BioArctic AB (BIOA B) announced that the European Medicines Agency's CHMP has reaffirmed its positive opinion for lecanemab (Leqembi®) in early Alzheimer's disease, originally adopted in November 2024. This follows the European Commission's January 2025 request to review additional safety information and risk minimization measures clarity.

Leqembi, an anti-Aβ monoclonal antibody targeting toxic protofibrils and Aβ plaques, is already approved in the US, Japan, China, and Great Britain. If approved by the EC, the marketing authorization will extend to all 27 EU member states, Iceland, Liechtenstein, and Norway.

BioArctic AB announced the completion of its global license agreement with Bristol Myers Squibb after receiving U.S. Federal Trade Commission clearance. The agreement, initially announced on December 19, 2024, grants Bristol Myers Squibb worldwide development and commercialization rights for BAN1503 and BAN2803, part of BioArctic's PyroGlutamate-amyloid-beta antibody program for Alzheimer's disease.

The deal includes a USD 100 million upfront payment to BioArctic, potential milestone payments up to USD 1.25 billion, and tiered low double-digit royalties on global sales. BioArctic retains Nordic region co-commercialization rights and maintains rights to its BrainTransporter platform technology for other applications.

The PyroGlu-Aβ antibody program targets a specific modified form of amyloid-beta that tends to aggregate and cause Alzheimer's symptoms. BAN2803 incorporates BioArctic's BrainTransporter technology, marking the first license agreement utilizing this platform.

BioArctic AB (Nasdaq Stockholm: BIOA B) announced that its partner Eisai has achieved the first sales milestone for Leqembi®, reaching €200 million in sales during Eisai's fiscal year 2024 (April 2024 - March 2025). This achievement triggers a €10 million milestone payment to BioArctic.

Leqembi, an antibody developed through collaboration between BioArctic and Eisai, originated from Professor Lars Lannfelt's research on the Arctic mutation in Alzheimer's disease. While Eisai manages clinical development, market approval applications, and global commercialization, BioArctic retains rights to commercialize Leqembi in the Nordic region jointly with Eisai, with preparations for regional commercialization currently underway.