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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
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.
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.
Nytt samarbeid for BrainTransporter, denne gangen i glioblastom
BioArctic and Mesenkia enter oncology research collaboration
2026-08-19 11:15:00
Stockholm, Sweden, August 19, 2026 - BioArctic AB (publ) (Nasdaq Stockholm: BIOA B) and Mesenkia Therapeutics announced today that the companies have signed a research collaboration agreement to explore a novel antibody-based approach for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer, where effective delivery of large molecules to the brain remains a major challenge.
The collaboration combines BioArctic’s proprietary BrainTransporter™ technology with an antibody, developed with Mesenkia’s KITAIbodies® platform. The antibody targets HVEM[1], a protein found on the surface of certain glioblastoma tumor cells, including tumor stem cells. By addressing these cells, which are thought to contribute to tumor recurrence and treatment resistance, the project aims to unlock new treatment possibilities for patients with a very high unmet medical need.
Under the agreement, BioArctic will be responsible for generating a novel drug candidate by combining its BrainTransporter technology with Mesenkia’s antibody. BioArctic and Mesenkia thereafter plan to perform preclinical studies to validate the concept and, based on the results of these studies, decide on next steps.
This research collaboration represents an important step in expanding BioArctic’s BrainTransporter pipeline into oncology and further validates the platform’s potential beyond neurodegenerative diseases. It also builds on BioArctic’s core expertise in development and delivery of pharmaceuticals to the brain.
“We are excited to broaden our research and take a first step into oncology through this collaboration,” said Gunilla Osswald, Chief Executive Officer of BioArctic. “Glioblastoma remains one of the most challenging cancers to treat, with limited therapeutic options and poor prognosis for those affected. By combining our BrainTransporter technology with Mesenkia’s innovative antibody approach, we aim to target key disease-driving mechanisms to develop new ways to treat this devastating disease.”
“This agreement marks an important step for Mesenkia and creates clear opportunities to explore a new treatment strategy for patients with glioblastoma together with BioArctic. The need for new treatments is substantial, particularly given the challenge of delivering medicines to tumor cells throughout the brain. By combining Mesenkia’s antibody expertise with BioArctic’s BrainTransporter technology, we can address one of the disease’s key barriers in a new way. We look forward to advancing the concept together with BioArctic, with the long-term goal of enabling better treatment options for patients and their loved ones,” said Moa Fransson, Chief Executive Officer of Mesenkia.
BioArctic: Leqembi Iqlik® for initiation treatment launched in the US
2026-08-24 14:05:00
Stockholm, Sweden, August 24, 2026 - 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.
Interim Report for the period April - June 2026
2026-08-26 08:00:00
New approvals for Leqembi ® and additional strategic partnerships
Events during the second quarter 2026
- Eisai provided a sales forecast for Leqembi for the company’s fiscal year 2026 (April 2026 to March 2027) of a total of JPY 143.5 billion (approximately SEK 8.4 billion), corresponding to 63% growth compared with the previous year
- BioArctic 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 drug candidate from Eli Lilly targeting neurodegeneration. As part of the agreement, BioArctic will receive an upfront payment of USD 30 million. The agreement is worth up to USD 800 million plus royalties
Events after the end of the period
- The US Food and Drug Administration (FDA) approved the supplemental application for Leqembi Iqlik® subcutaneous autoinjector as a weekly initiation treatment for patients with early Alzheimer’s disease. Following the approval, Leqembi Iqlik was launched in the US in August
- Data from the LEADER study presented at AAIC (Alzheimer’s Association International Conference) in London on July 12-15 showed that more than 75% of patients treated with Leqembi remained stable, while nearly 7% improved after an average of 17 months of treatment
- BioArctic entered into a research collaboration in oncology with the Swedish biotech company Mesenkia Therapeutics to explore a novel antibody-based treatment for glioblastoma
Financial summary April - June 2026
- Net revenues amounted to SEK 247.5 M (392.1), of which SEK 179.4 M (162.5) related to royalty income for Leqembi
- Operating profit amounted to SEK -6.5 M (179.1)
- Profit for the period amounted to SEK -11.2 M (96.6)
- Earnings per share before dilution amounted to SEK -0.13 (1.09)
- Earnings per share after dilution amounted to SEK -0.13 (1.09)
- Cash flow from operating activities amounted to SEK 137.8 M (1,147.1)
- Cash and cash equivalents, including short term investments, amounted to SEK 1,990.0 M (1,916.1) at the end of the period
Comments from the CEO
“The agreement with Eli Lilly is more than a strategic business deal - it is a confirmation of the innovative strength that we at BioArctic have built over the years”During the second quarter, BioArctic took important steps in our continued development, highlighted by our new research and collaboration agreement with Eli Lilly, which demonstrates the strength of both our research capabilities and our BrainTransporter technology.
An attractive partner for future treatments
For me, the agreement with Eli Lilly is more than a strategic business deal - it is a confirmation of the innovative strength that we at BioArctic have built over the years. The fact that yet another world-leading pharmaceutical company has chosen to combine its own drug candidate with our BrainTransporter technology is a strong recognition of the platform’s potential and further strengthens BioArctic’s position, both as a research company and as an attractive partner to the global pharmaceutical industry. Under the agreement, BioArctic will receive an upfront payment of USD 30 million to develop a new drug candidate combining our BrainTransporter with a compound developed by Eli Lilly. They will subsequently be responsible for global development and commercialization. The partnership has the potential to generate milestone payments of up to USD 770 million, as well as tiered royalties on global sales at a mid-single-digit percentage rate, should the product reach the market.
In August, we also entered into a new research collaboration with the Swedish biotech company Mesenkia Therapeutics. By combining our BrainTransporter technology with Mesenkia’s expertise in tumor biology, we will explore a novel antibody-based treatment for glioblastoma, one of the most aggressive and treatment-resistant forms of brain cancer. It is incredibly exciting to expand our research into a new area and take our first step into oncology.
Increased flexibility for patients with Alzheimer’s
Another important milestone was reached in July when the US FDA approved Leqembi Iqlik for subcutaneous administration from the start of treatment in the US, which strengthens our competitiveness compared with other treatment options. Following the approval, Leqembi Iqlik was launched in the US in August. For people living with Alzheimer’s disease, innovation is not only about developing new medicines, but also about making treatment simpler and more accessible. The ability for patients and carers to administer the therapy at home using an autoinjector provides greater flexibility, while also easing the burden on healthcare systems. Combined with advances in blood-based diagnostics, this opens opportunities to reach more patients and further expand the use of Leqembi. We look forward to more patients around the world ultimately being able to benefit from this treatment option. In Japan, we expect a decision in the third quarter regarding administration using an autoinjector from initiation of treatment.
Continued growth for Leqembi
Global sales of Leqembi increased during the quarter, amounting to JPY 29.3 billion, generating royalty revenue for BioArctic of SEK 179 million, an increase of approximately 10 percent compared with the corresponding quarter of the previous year.
The growing number of patients being treated with Leqembi is also giving us an increasingly clear view of the difference the medicine can make for people living with Alzheimer’s disease. At the AAIC (Alzheimer’s Association International Conference) in London in July, several new results were presented, demonstrating how rapidly the field is advancing. The interim results from the LEADER study were particularly encouraging, reflecting experience from clinical use in the US. The study showed that more than 75 percent of patients with early Alzheimer’s disease remained stable and nearly seven percent improved after an average of 17 months of treatment. For a disease otherwise characterized by clear and progressive decline, these are significant results. It is both inspiring and encouraging to see the latest advances in research. I am convinced that we are still only at the beginning of a treatment revolution in Alzheimer’s disease.
A strong research pipeline for the future
While Leqembi continues to become established globally and BrainTransporter is further developed for new modalities, we are building a strong research pipeline in neurodegenerative diseases. One important focus is exidavnemab, where we received safety data from the Phase 2a study during the quarter, confirming the drug candidate’s favorable safety profile. These results provide a solid foundation for planning the Phase 2b studies in multiple system atrophy (MSA) and Parkinson’s disease-related dementia, which we expect to initiate in the first half of 2027.
Well positioned in our growth era
Looking back on the quarter, I conclude that we continue to take important steps forward on our growth journey. We have an established product on the market, an innovative project portfolio, a growing revenue base and a technology platform that has been validated by yet another global pharmaceutical company. This puts us in a strong position to continue investing in our pipeline and developing the next generation of treatments for neurological diseases. I would like to thank all our employees whose expertise and dedication make these advances possible. Together, we continue to build BioArctic’s future and contribute to enabling more patients to gain access to innovative treatments.
Gunilla Osswald
CEO, BioArctic AB
Da var subq også på plass for Kina
BioArctic: Leqembi® subcutaneous formulation approved for initiation treatment in China]
2026-09-03 06:00:00
Stockholm, Sweden, September 3, 2026 - BioArctic AB’s (publ) (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the National Medical Products Administration (NMPA) of China has approved the Leqembi subcutaneous autoinjector formulation (Leqembi SC-AI) as an initiation treatment for mild cognitive impairment (MCI) due to Alzheimer’s disease (AD) or mild AD dementia (collectively referred to as early AD).
The application was accepted by the NMPA in January 2026 and was subsequently granted Priority Review designation. Launch in China is planned during Eisai’s Fiscal Year 2026 which ends on March 31, 2027.
Leqembi SC-AI is a self-administered autoinjector formulation. The approved regimen is 500 mg given once weekly as two consecutive 250 mg injections. With this approval, Leqembi treatment now offers a new option of once-weekly SC administration at home, as an alternative to intravenous (IV) administration every two weeks in a hospital setting. Patients may also switch between IV and SC administration during treatment.
Leqembi SC-AI may significantly reduce the time required for IV infusions (approximate injection time of 15 seconds per injection). In addition, at-home administration may reduce the burden of clinic visits for patients and their care partners and enable treatment options that better fit their lifestyles. The subcutaneous treatment option is expected to lower barriers to initiating and continuing treatment. Furthermore, Leqembi SC-AI also has the potential to reduce healthcare resources associated with IV dosing, such as nurse monitoring and maintaining infusion capacity. For ARIA (amyloid-related imaging abnormalities) monitoring, as with IV administration, brain magnetic resonance imaging (MRI) is performed prior to initiating treatment and at specified time points after treatment initiation.
This marks the second country globally to approve Leqembi SC-AI. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of Leqembi in patients with early Alzheimer’s disease, as well as multiple subcutaneous administration sub-studies (including the Chinese cohort) in its subsequent long-term extension (LTE). Once-weekly administration of SC-AI 500mg demonstrated exposure equivalent to IV administration once every two weeks, with similar clinical and biomarker outcomes. The overall safety profile of SC administration was generally similar to that of IV administration. Injection-related reactions were observed with subcutaneous Leqembi, most of which were localized, while systemic reactions were less frequently observed.
Eisai estimates that there were 17 million patients with MCI or mild dementia due to Alzheimer’s disease in China in 2024, a number that is expected to increase as the population ages. Leqembi was launched in China in June 2024.
BioArctic: Leqembi® Pen subcutaneous formulation approved in Japan
2026-09-16 08:05:00
Stockholm, Sweden, September 16, 2026 - BioArctic AB (publ)'s (Nasdaq Stockholm: BIOA B) partner Eisai announced today that the subcutaneous autoinjector formulation of Leqembi (known as Leqembi Pen in Japan) has been approved as a new route of administration for the treatment of early Alzheimer’s disease.
Leqembi Pen enables patients or care partners to self-administer treatment, with two injections (totaling 500 mg) given once weekly. This approval in Japan provides people living with early Alzheimer’s disease with an additional treatment option, allowing once-weekly subcutaneous administration at home[1], complementing the existing intravenous (IV) formulation, which is administered every two weeks in a hospital setting.
Leqembi Pen may reduce the time required for treatment administration compared with IV infusions, with each injection taking approximately 15 seconds. The option for at-home administration may reduce the burden of clinic visits for patients and their care partners and provide a treatment option that better fits their lifestyles.
The subcutaneous treatment option is expected to lower barriers to initiating and continuing treatment and has the potential to reduce healthcare resources associated with IV administration, such as nurse monitoring and maintaining infusion capacity. This may help streamline the overall Alzheimer’s disease treatment pathway.
As with IV administration, monitoring for ARIA (amyloid-related imaging abnormalities) involves brain magnetic resonance imaging (MRI) before treatment is initiated and at specified time points thereafter.
Japan is the third country globally to approve the subcutaneous formulation of Leqembi. This approval is based on the integrated results of data and associated modeling and simulation from the 18-month core study of the Phase 3 Clarity AD study of Leqembi in patients with mild cognitive impairment (MCI) due to AD or mild AD dementia (collectively referred to as early AD), as well as multiple subcutaneous administration sub-studies in its subsequent long-term extension (LTE). Once-weekly administration of the 500 mg subcutaneous formulation demonstrated similar exposure to IV administration once every two weeks and supported the expectation that the subcutaneous formulation provides efficacy comparable to that of the IV formulation. The overall safety profile of subcutaneous administration was generally similar to that of IV administration, while systemic injection/infusion-related reactions were observed less frequently with subcutaneous administration (1.4%) compared with IV administration.