/PRNewswire/ -- BioArctic AB's (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for once-weekly lecanemab-irmb subcutaneous injection (US brand name: Leqembi Iqlik) as an initial dose for treating early Alzheimer's disease. The US launch is planned for late August 2026.

Leqembi Iqlik represents a pioneering anti-amyloid therapy worldwide that enables at-home dosing for both initiation and maintenance phases. Delivered through an autoinjector, it offers a convenient option instead of intravenous (IV) infusion right from treatment start. The approved initiation schedule calls for 500 mg once weekly, given as two separate 250 mg injections each taking about 15 seconds.

Leqembi Iqlik already holds approval for maintenance dosing in the US at 360 mg once weekly after completing 18 months of IV or subcutaneous therapy. Patients may now receive Leqembi via IV infusion or subcutaneous injection with Leqembi Iqlik across the full treatment period - from initiation through maintenance - and can switch between methods when needed for added flexibility and convenience.

Leqembi is indicated in the US for adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, together known as early Alzheimer's disease. MCI due to Alzheimer's disease marks the earliest symptomatic phase and can involve subtle shifts in memory, thinking, language, or daily activities.

Clinical data backing FDA approval of subcutaneous initiation dosing

The FDA approval for Leqembi Iqlik as an initiation option rests on extensive clinical data from multiple studies and dosing schedules evaluating subcutaneous lecanemab. Findings from sub-studies in the Phase 3 Clarity AD long-term extension (LTE), performed after the 18-month core trial in people with early Alzheimer's disease, demonstrated:

Once-weekly subcutaneous dosing produced exposure levels matching intravenous administration, supporting comparable clinical efficacy and biomarker outcomes including amyloid removal.
The incidence of exposure-related adverse events such as ARIA-E with subcutaneous use is anticipated to align with IV administration. No rise in isolated ARIA-H (ARIA-H without accompanying ARIA-E) occurred for Leqembi versus placebo.
The overall safety profile for subcutaneous administration remained generally consistent with intravenous use. Injection-related reactions appeared with subcutaneous Leqembi, mostly localized, while systemic reactions occurred less often.

"This approval marks another key advance in Alzheimer's disease treatment," stated Gunilla Osswald, CEO of BioArctic. "Offering a new administration choice from the outset gives patients, caregivers, and healthcare professionals more flexibility in therapy delivery. As the Alzheimer's treatment field evolves, innovations that ease access and enable personalized care grow increasingly vital. We welcome Eisai's ongoing efforts to address the varied needs of those facing this challenging condition."

Broadening treatment flexibility along the Alzheimer's disease care pathway

Approval of Leqembi Iqlik as a subcutaneous starting dose supplies patients and care partners with the sole at-home administration choice throughout the Alzheimer's disease treatment journey, potentially aiding access and care delivery in varied healthcare settings. Subcutaneous administration can:

Lessen the load of clinic visits for patients and care partners
Lower dependence on infusion centers and related healthcare resources
Shorten treatment preparation and administration time along with nursing oversight needs
Maintain infusion capacity for those who prefer or need intravenous therapy

Results from an autoinjector acceptability study showed that 94% of patients with early Alzheimer's disease and their care partners rated the Leqembi Iqlik device as easy to use, reporting strong satisfaction and confidence for at-home application.

Please see full Prescribing Information for Leqembi, including Boxed WARNING.

This is information that BioArctic AB (publ) is obliged to disclose pursuant to the EU Market Abuse Regulation. The information was released for public disclosure, through the agency of the contact person below, on July 13, 2026, at 11:55 pm CEST.

For further information, please contact:
Oskar Bosson, VP Communications and Investor Relations
E-mail: [email protected]
Telephone: +46 704 107 180

Jenny Ljunggren, External Communications and Investor Relations Manager
E-mail: [email protected]
Telephone: +46 76 013 86 08

About Leqembi (lecanemab)

Leqembi stems from a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody targeting aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

Leqembi is approved in 53 countries and under regulatory review in 6 countries. After the initial every-two-weeks phase for 18 months, intravenous maintenance dosing every four weeks is approved in 8 countries including the United Kingdom, China, the US, and Japan, with applications filed in 12 countries and regions. In the US, Leqembi Iqlik is approved for subcutaneous dosing via autoinjector as both a starting dose and maintenance treatment of early Alzheimer's disease. In November 2025, a new drug application for the subcutaneous formulation of Leqembi was submitted in Japan. In December 2025, Leqembi was added to the "Commercial Insurance Innovative Drug List" recently introduced by China's National Healthcare Security Administration (NHSA). In January 2026, the Biologics License Application for the subcutaneous formulation of Leqembi was accepted in China, and in February it received priority review designation.

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease - those clinically normal yet showing intermediate or elevated brain amyloid levels - continues. The study reached full recruitment in October 2024. AHEAD 3-45 is a four-year study run as a public-private partnership between Eisai, Biogen, and the Alzheimer's Clinical Trial Consortium, which supplies infrastructure for academic clinical trials in Alzheimer's disease and related dementias in the US, funded by the National Institute on Aging, part of the National Institutes of Health. Since January 2022, the Tau NexGen clinical study for Dominantly Inherited Alzheimer's disease (DIAD), conducted by the Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU) led by Washington University School of Medicine in St. Louis, remains ongoing and incorporates lecanemab as the core anti-amyloid therapy.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has maintained a long-term collaboration with Eisai on the development and commercialization of drugs for Alzheimer's disease treatment. Key agreements include the Development and Commercialization agreement for the lecanemab antibody signed in 2007 and the Development and Commercialization agreement for the lecanemab back-up antibody for Alzheimer's disease signed in 2015. In 2014, Eisai and Biogen entered a joint development and commercialization agreement for lecanemab. Eisai handles clinical development, market approval applications, and commercialization of the products for Alzheimer's disease. BioArctic holds rights to commercialize lecanemab in the Nordic region and is preparing for Nordic commercialization alongside Eisai. BioArctic incurs no development costs for lecanemab in Alzheimer's disease and receives payments tied to sales milestones plus royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focused on innovative treatments that can delay or halt progression of neurodegenerative diseases. The company invented Leqembi (lecanemab) - the world's first drug shown to slow disease progression and reduce cognitive impairment in early Alzheimer's disease. Leqembi was developed with BioArctic's partner Eisai, which manages regulatory interactions and global commercialization. Beyond Leqembi, BioArctic maintains a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional Alzheimer's disease projects. Several projects leverage the company's proprietary BrainTransporter technology, which holds potential to actively transport antibodies across the blood-brain barrier and boost treatment efficacy. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

[1] Based on in-person interviews of 50 patients with early Alzheimer's Disease and 50 care partners currently assisting people with early AD. Participants interacted with a training autoinjector device (containing no needles or medication) and an injection pad, then completed computer-based surveys about their experience, including "How difficult or easy was it to use the self-injection device?"

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