Leqembi Iqlik® for initiation treatment launched in the US

Rhea-AI Summary

BioArctic (NASDAQ Stockholm: BIOA B) reports that partner Eisai has launched lecanemab-irmb subcutaneous injection, branded Leqembi Iqlik, in the US for initiation therapy in early Alzheimer's disease, following FDA approval on July 13. The at-home autoinjector provides a first-of-its-kind anti-amyloid option for both initiation and maintenance treatment, offering an alternative to intravenous infusions. The approved US initiation regimen is 500 mg once weekly, delivered as two 250 mg injections of about 15 seconds each. MRI monitoring for ARIA remains required. Leqembi, originating from BioArctic and Eisai’s alliance, is now approved in 53 countries, with BioArctic entitled to sales milestones and global royalties while bearing no development costs for Alzheimer's indications.

Positive

• US launch of Leqembi Iqlik subcutaneous initiation therapy for early Alzheimer’s disease
• At-home autoinjector provides alternative to IV infusion for initiation and maintenance
• Leqembi approvals in 53 countries with BioArctic earning milestones and global royalties, no Alzheimer’s development costs

Negative

• None.

Market Context

WPM recorded a 1.99% change in current peer data, while no peer appeared in the momentum scanner. Th...

Analysis

WPM recorded a 1.99% change in current peer data, while no peer appeared in the momentum scanner. That platform context frames the launch against mixed signals, with required MRI monitoring remaining a stated treatment risk.

Key Figures

FDA approval date: July 13 Initiation dose: 500 mg once weekly Injection dose: Two 250 mg injections +5 more

8 metrics

FDA approval date July 13 Leqembi Iqlik subcutaneous formulation

Initiation dose 500 mg once weekly Approved US initiation regimen

Injection dose Two 250 mg injections Each weekly initiation administration

Administration time Approximately 15 seconds Each injection

Countries approved 53 countries Leqembi approval status

Countries under review 6 countries Leqembi regulatory status

IV maintenance approvals 8 countries Treatment every four weeks

AHEAD 3-45 study duration Four-year study Phase 3 preclinical Alzheimer's disease study

Historical Context

5 past events · Latest: Aug 19 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
Aug 19	Oncology collaboration	Positive	+7.2%	BioArctic and Mesenkia signed a glioblastoma research collaboration agreement.
Aug 19	Quarterly report notice	Neutral	+7.2%	BioArctic scheduled its second-quarter report and investor webcast.
Aug 11	Leadership appointment	Neutral	-1.8%	Barrick appointed Sebastiaan Bock as Chief Executive Officer, Rest of World.
Aug 10	Joint venture agreement	Positive	-6.4%	Barrick and Newmont amended their Nevada Gold Mines joint venture agreement.
Aug 10	Second-quarter earnings	Positive	-6.4%	Barrick reported higher production, revenue, earnings, and shareholder returns.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent records were mixed, with one aligned positive reaction and four divergences, including negative reactions after positive Barrick announcements.

Key Terms

subcutaneous injection, autoinjector, igg1 monoclonal antibody

3 terms

subcutaneous injection medical

"lecanemab-irmb subcutaneous injection (US brand name: Leqembi Iqlik®)"

A subcutaneous injection is a method of delivering a medicine or vaccine by inserting a small needle just under the skin into the thin layer of fat beneath the outer skin. For investors, administration by subcutaneous injection matters because it influences patient convenience, dosing frequency, manufacturing complexity and distribution costs, all of which affect how widely a treatment is adopted and how it is priced—like choosing a product that customers can easily use at home versus one that needs a clinic visit.

autoinjector technical

"Leqembi Iqlik is administered via an autoinjector"

A prefilled, spring‑loaded medical device that automatically delivers a measured dose of medication beneath the skin when pressed against the body, like a self‑operating syringe packaged for quick use. Investors care because autoinjectors can increase patient safety, adherence and convenience — factors that drive demand, shape reimbursement and regulatory review, and affect a product’s market size, manufacturing complexity and competitive moat.

igg1 monoclonal antibody medical

"a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody"

A IgG1 monoclonal antibody is a lab-made protein that mimics one specific type of human antibody (the IgG1 subclass) and is produced from a single immune-cell clone so every molecule is identical. It matters to investors because the IgG1 subtype has predictable properties—longer circulation in blood and ability to engage immune-system functions—which influence a drug’s dosing, safety profile, and potential effectiveness, similar to choosing a vehicle with known fuel efficiency and cargo capacity.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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STOCKHOLM, Aug. 24, 2026 /PRNewswire/ -- BioArctic AB's (publ) (NASDAQ STOCKHOLM: BIOA B) partner Eisai today announced that lecanemab-irmb subcutaneous injection (US brand name: Leqembi Iqlik®), which was approved by the FDA on July 13, now is available in the US for initiation therapy for early Alzheimer's disease[1]. Leqembi Iqlik is the first-of-its-kind anti-amyloid treatment that offers at-home dosing for initiation and maintenance (approved in the US).

Leqembi Iqlik is administered via an autoinjector, introducing a convenient alternative to intravenous (IV) infusion from the start of treatment. For initiation, the approved regimen is 500 mg once weekly, delivered as two 250 mg injections, each administered in approximately 15 seconds.

Expanding convenience and flexibility in Alzheimer's care

The availability of Leqembi Iqlik for both initiation and maintenance therapy in the US offers patients and carers greater convenience and flexibility throughout the treatment journey. At-home administration reduces the need for IV infusions and clinic visits, making treatment easier to integrate into daily life. Leqembi Iqlik may also help reduce healthcare resource utilization associated with IV administration. As with intravenous treatment, MRI monitoring for ARIA is required before treatment initiation and at specified time points thereafter.

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

The information was released for public disclosure, through the agency of the contact person below, on August 24, 2026, at 2:05 pm CEST.

For further information, please contact: 
Oskar Bosson, Chief Investor Relations & Communications Officer
E-mail: oskar.bosson@bioarctic.com
Telephone: +46 704 107 180

Jenny Ljunggren, External Communications and Investor Relations Manager
E-mail: jenny.ljunggren@bioarctic.com
Telephone: +46 76 013 86 08

About Leqembi® (lecanemab)
Leqembi is the result of a strategic research alliance between BioArctic and Eisai. It is a humanized immunoglobulin gamma 1 (IgG1) monoclonal antibody directed against aggregated soluble (protofibril) and insoluble forms of amyloid-beta (Aβ).

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

Since July 2020, Eisai's Phase 3 clinical study (AHEAD 3-45) with lecanemab in individuals with preclinical Alzheimer's disease meaning they are clinically normal and have intermediate or elevated levels of amyloid in their brains, is ongoing. The study was fully recruited in October 2024. AHEAD 3-45 is a four-year study conducted as a public-private partnership between Eisai, Biogen and the Alzheimer's Clinical Trial Consortium that provides the 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), that is conducted by Dominantly Inherited Alzheimer Network Trials Unit (DIAN-TU), led by Washington University School of Medicine in St. Louis, is ongoing and includes lecanemab as the backbone anti-amyloid therapy.

About the collaboration between BioArctic and Eisai

Since 2005, BioArctic has a long-term collaboration with Eisai regarding the development and commercialization of drugs for the treatment of Alzheimer's disease. The most important agreements are the Development and Commercialization agreement for the lecanemab antibody, which was signed 2007, and the Development and Commercialization agreement for the antibody lecanemab back-up for Alzheimer's disease, which was signed 2015. In 2014, Eisai and Biogen entered into a joint development and commercialization agreement for lecanemab. Eisai is responsible for the clinical development, application for market approval and commercialization of the products for Alzheimer's disease. BioArctic has the right to commercialize lecanemab in the Nordic region and is currently preparing for commercialization in the Nordics together with Eisai. BioArctic has no development costs for lecanemab in Alzheimer's disease and is entitled to payments in connection with sales milestones as well as royalties on global sales.

About BioArctic AB

BioArctic AB (publ) is a Swedish research-based biopharma company focusing on innovative treatments that can delay or stop the progression of neurodegenerative diseases. The company invented Leqembi® (lecanemab) – the world's first drug proven to slow the progression of the disease and reduce cognitive impairment in early Alzheimer's disease. Leqembi has been developed together with BioArctic's partner Eisai, who are responsible for regulatory interactions and commercialization globally. In addition to Leqembi, BioArctic has a broad research portfolio with antibodies against Parkinson's disease and ALS as well as additional projects against Alzheimer's disease. Several of the projects utilize the company's proprietary BrainTransporter™ technology, which has the potential to actively transport antibodies across the blood-brain barrier to enhance the efficacy of the treatment. BioArctic's B share (BIOA B) is listed on Nasdaq Stockholm Large Cap. For further information, please visit www.bioarctic.com.

^[1] Mild cognitive impairment (MCI) or mild dementia due to Alzheimer's disease, is collectively referred to as early Alzheimer's disease.

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Leqembi Iqlik® for initiation treatment launched in the US

 

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SOURCE BioArctic

FAQ

What did BioArctic (BIOA B) announce about Leqembi Iqlik in the US on August 24, 2026?

BioArctic announced that partner Eisai has launched Leqembi Iqlik subcutaneous injection in the US as initiation therapy for early Alzheimer’s disease. According to BioArctic, this follows FDA approval on July 13 and enables at-home dosing via an autoinjector for initiation and maintenance treatment.

How is Leqembi Iqlik dosed for initiation treatment in early Alzheimer’s disease in the US?

Leqembi Iqlik’s approved US initiation regimen is 500 mg once weekly, given as two 250 mg injections. According to Eisai and BioArctic, each injection is administered over about 15 seconds, offering a subcutaneous, at-home alternative to clinic-based intravenous infusions from treatment start.

What makes Leqembi Iqlik different from intravenous Leqembi for BioArctic (BIOA B) investors?

Leqembi Iqlik is a subcutaneous autoinjector formulation that allows at-home dosing for initiation and maintenance, unlike IV infusions. According to BioArctic, this may reduce clinic visits and IV resource use, potentially supporting broader real-world use of lecanemab-based therapy in early Alzheimer’s disease.

In how many countries is Leqembi (lecanemab) approved, and what is BioArctic’s role?

Leqembi is approved in 53 countries and under review in six more. According to BioArctic, Eisai leads development, approval and commercialization, while BioArctic holds Nordic commercialization rights, pays no Alzheimer’s development costs, and receives sales milestone payments plus royalties on global sales.

What monitoring is required when starting Leqembi Iqlik treatment in early Alzheimer’s disease?

Patients starting Leqembi Iqlik require MRI monitoring for ARIA before initiation and at defined time points. According to BioArctic, this safety monitoring requirement mirrors intravenous lecanemab treatment. Prescribers are directed to consult the full Leqembi Prescribing Information, including the boxed warning, for detailed guidance.

How does the Leqembi Iqlik launch potentially impact BioArctic (BIOA B) financially?

BioArctic does not bear lecanemab development costs in Alzheimer’s disease but is entitled to sales milestones and royalties on global sales. According to BioArctic, Eisai commercializes worldwide, so increased use of Leqembi Iqlik in the US could support future milestone and royalty revenue for BioArctic.

What ongoing lecanemab clinical studies are relevant to BioArctic (BIOA B) and Leqembi?

Key ongoing studies include AHEAD 3-45 in preclinical Alzheimer’s and Tau NexGen in dominantly inherited Alzheimer’s. According to BioArctic, AHEAD 3-45 fully recruited in October 2024, and both trials continue to evaluate lecanemab’s role as anti-amyloid backbone therapy in earlier disease stages.