Diskusjon Triggere Porteføljer Aksjonærlister

BioArctic AB

Norge ser ut til å følge sine skandinaviske brødre

https://www.fiercepharma.com/manufacturing/eisai-snares-government-manufacturing-grant-it-brings-leqembi-packaging-uk-65m

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BioArctic and Lilly sign research and collaboration agreement combining Lilly compound with BioArctic’s BrainTransporter™ technology

2026-06-22 07:32:30

Stockholm, Sweden, June 22, 2026 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) today announced that the company has entered into a research and collaboration agreement with Eli Lilly and Company regarding a potential new treatment combining BioArctic’s proprietary BrainTransporter technology with an undisclosed Lilly drug candidate in neurodegeneration. As part of the agreement, BioArctic will receive USD 30 million in upfront payment.

In addition to the upfront payment, BioArctic will be eligible to receive additional milestone payments of up to USD 770 million. BioArctic will also be entitled to tiered mid-single digit royalties on future global product sales if the product reaches the market.

Under the collaboration, BioArctic will generate a new drug candidate combining the BrainTransporter technology with a Lilly proprietary molecule. Lilly will assume full responsibility for the global development and commercialization of the drug candidate and related products.

“I’m excited by today’s announcement and proud that a large pharmaceutical company sees potential in our proprietary BrainTransporter technology. Lilly shares our ambition to do more for patients with severe neurological disorders, and this collaboration is a testament to that,” said Gunilla Osswald, CEO at BioArctic.

This agreement is the fourth collaboration BioArctic has entered into with partners using the BrainTransporter technology. BioArctic retains all rights for use of the BrainTransporter platform outside of the scope of these four agreements. The BrainTransporter platform can be used in a multitude of different therapy areas for delivery of biologics and other modalities to the brain, giving BioArctic many potential future partnering opportunities.

Da er det 4 avtaler/samarbeid på BrainTransporter så langt;
Eisai, BMS, Novartis og nå Eli Lilly

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Da var denne på plass

BioArctic: FDA approves Leqembi Iqlik® (lecanemab-irmb) subcutaneous injection as a starting dose for early Alzheimer’s disease

2026-07-13 23:55:00

Stockholm, Sweden, July 13, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today announced that the US Food and Drug Administration (FDA) has approved a supplemental Biologics License Application (sBLA) for a once weekly lecanemab irmb subcutaneous injection (US brand name: Leqembi Iqlik®) as a starting dose for the treatment of early Alzheimer’s disease. The US launch is planned for late August 2026.

Leqembi Iqlik is a first-of-its-kind anti-amyloid treatment worldwide, offering at-home dosing for initiation and maintenance. It is administered via an autoinjector, offering 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.

Leqembi Iqlik is already approved for maintenance dosing in the US at 360 mg once weekly, once 18 months of IV or subcutaneous treatment has been completed. Patients can now receive Leqembi either as an IV infusion or as a subcutaneous injection (SC) with Leqembi Iqlik throughout the entire treatment course - from initiation through maintenance and may switch between administration methods as needed, providing greater flexibility and convenience.

Leqembi is indicated in the US for the treatment of adults with mild cognitive impairment (MCI) or mild dementia due to Alzheimer’s disease, collectively referred to as early Alzheimer’s disease. MCI due to Alzheimer’s disease represents the earliest symptomatic stage of the disease and may be associated with subtle changes in memory, thinking, language, or daily functioning.

Clinical data supporting FDA approval of subcutaneous initiation dosing

The FDA approval of Leqembi Iqlik for treatment initiation is supported by a comprehensive clinical data package evaluating SC administration of lecanemab across multiple studies and dosing regimens. Data from sub-studies within the Phase 3 Clarity AD long-term extension (LTE), conducted following the 18-month core study in individuals with early Alzheimer’s disease, showed:

  • Once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, supporting similar clinical (efficacy) and biomarker (amyloid removal) benefits.

  • The rate of exposure-related adverse events such as ARIA-E with SC administration is expected to be comparable with IV administration. There was no increase in isolated ARIA-H (i.e., ARIA-H in patients who did not also experience ARIA-E) for Leqembi compared to placebo.

  • The overall safety profile of SC administration was generally similar to intravenous administration. Injection-related reactions were observed with subcutaneous Leqembi, most of which were localized, while systemic reactions were less frequently observed.

“This approval represents another important step forward in the treatment of Alzheimer’s disease,” said Gunilla Osswald, CEO of BioArctic. “By providing a new administration option from the start of treatment, patients, caregivers and healthcare professionals gain greater flexibility in how therapy is delivered. As the Alzheimer’s treatment landscape continues to advance, innovations that simplify access and support individualized care will be increasingly important. We are encouraged to see Eisai’s diligent work to meet the diverse needs of people living with this difficult disease.”

Expanding treatment flexibility across the Alzheimer’s disease care pathway

The approval of Leqembi Iqlik as a subcutaneous starting dose provides patients and care partners with the only at-home administration option throughout the Alzheimer’s disease treatment journey which could support access and delivery of care across healthcare settings. Subcutaneous administration may:

  • Reduce the burden of clinic visits for patients and care partners

  • Reduce reliance on infusion and associated healthcare resources

  • Decrease treatment preparation and administration time, and nursing monitoring requirements

  • Preserve infusion capacity for patients who prefer or require intravenous therapy

Insights from an autoinjector acceptability study indicated that 94% of patients with early Alzheimer’s disease and their care partners found the Leqembi Iqlik device easy to use, with high levels of satisfaction and confidence in using it in an at-home setting.

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BioArctic: Sales of Leqembi® totaled 29.3 billion yen in the second quarter 2026

2026-07-29 12:00:00

Stockholm, Sweden, July 29, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai today published the preliminary global revenue for Leqembi for the second quarter 2026, in conjunction with their partner Biogen’s second quarter report. In total, sales of JPY 29.3 billion were recorded in the period. This results in a royalty to BioArctic amounting to SEK 179 million, which is an increase of approximately 10 percent compared to the royalty recorded by BioArctic for the second quarter 2025.

The results in Q2 2025 included a one-time stockpiling effect in the Chinese market of around JPY 5.3 billion. Excluding the stockpiling effect, royalty revenues in Q2 2026 grew approximately 43 percent compared to the same quarter last year.

BioArctic’s report for the second quarter of 2026 will be published on August 26, 2026, at 08:00 CEST.

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