Eisai Co., Ltd.

Biogen's growth portfolio generated $1.06 billion in second-quarter 2026 revenues, up 24% year over year and 25% sequentially, surpassing the company's legacy MS portfolio, which brought in $767 million. Even excluding newly acquired Syfovre and Empaveli, growth-product revenues reached $933 million, up 9% year over year and 10% quarter over quarter, still above the legacy MS portfolio. Within the growth portfolio, Skyclarys revenues rose 29% to $168 million, Zurzuvae increased 53% to $71 million, Spinraza grew 2% to $402 million, and Vumerity fell 7.4% to $196.5 million, while Syfovre and Empaveli contributed $97.4 million and $30.4 million respectively. Alzheimer's collaboration revenues from Eisai for Leqembi rose 16% to $63.7 million, and the companies expect blood-based diagnostics and the launch of Leqembi Iqlik to drive further growth from 2027 onward. Biogen expects the growth portfolio to maintain its lead in the second half of 2026, with Syfovre and Empaveli contributing more than in the second quarter since revenue recognition began only in mid-May.

The U.S. Food and Drug Administration has approved the dual oral regimen of WELIREG (belzutifan) plus LENVIMA (lenvatinib) for the treatment of adult patients with advanced renal cell carcinoma with a clear cell component following a PD-1 or PD-L1 inhibitor, Merck and Eisai announced. The approval is based on data from the Phase 3 LITESPARK-011 trial, in which WELIREG plus LENVIMA reduced the risk of disease progression or death by 26% compared to cabozantinib, with a median progression-free survival of 14.6 months versus 10.6 months. The combination also showed an objective response rate of 53% versus 40% for cabozantinib, while overall survival did not meet statistical significance at the final analysis. WELIREG plus LENVIMA is the first approved combination of a HIF-2 alpha inhibitor and a multi-targeted VEGFR-TKI for these patients, and the companies said the LITESPARK-011 results will be presented at the upcoming European Society for Medical Oncology Congress 2026 in Madrid, Spain.

Eisai and U.S. pharmaceutical giant Biogen announced on the 16th that the subcutaneous formulation of lecanemab, a treatment for Alzheimer's disease sold under the brand name Leqembi, has received manufacturing and marketing approval from the Ministry of Health, Labour and Welfare. The product, named Leqembi Subcutaneous Injection 250mg Pen, can be administered in about 15 seconds per pen, with two pens used per dose. Until now, patients needed intravenous infusions at a hospital once every two weeks, but the subcutaneous formulation will allow once-weekly self-administration at home. Doctor prescriptions and hospital visits to confirm safety will still be required. Following deliberation and approval by the Central Social Insurance Medical Council, prescriptions are expected to begin between mid-November and mid-December, making this the third country to approve the subcutaneous version, after the United States and China.

Eisai Co., Ltd. and Biogen Inc. announced that China's National Medical Products Administration has approved the subcutaneous formulation of LEQEMBI (lecanemab) as an initiation treatment for early Alzheimer's disease, making it the first and only anti-amyloid therapy in China that enables at-home administration. The approval covers a once-weekly 500 mg regimen delivered via a subcutaneous autoinjector, offering an alternative to the intravenous infusion given every two weeks in a hospital. This marks the second country globally to approve the subcutaneous initiation treatment, following the United States in July 2026. The approval is based on data from the Phase 3 Clarity AD study and subcutaneous administration sub-studies, which showed equivalent exposure and similar safety and efficacy to the IV form. Eisai plans to launch the product in China during its fiscal year ending March 31, 2027, and estimates that there were 17 million patients with early Alzheimer's in China in 2024.

BioArctic AB's partner Eisai announced that Canada's Drug Agency has issued a final positive recommendation supporting public reimbursement of Leqembi (lecanemab) for eligible patients in Canada with mild cognitive impairment or mild dementia due to Alzheimer's disease. The recommendation follows a reconsideration and marks a step toward broader access, with next steps including negotiations through the pan-Canadian Pharmaceutical Alliance and subsequent reimbursement decisions by provincial and territorial drug plans. More than 770,000 people in Canada were estimated to be living with dementia in 2025, a number projected to rise to 1.7 million by 2050. Leqembi is approved in 53 countries and under review in 6, with maintenance dosing approved in 8 countries including the US, Japan, China, and the UK.

BioArctic reported its interim results for the second quarter of 2026, highlighting new approvals for Leqembi and strategic partnerships. The company entered into a research collaboration with Eli Lilly, receiving an upfront payment of USD 30 million, with the agreement worth up to USD 800 million plus royalties. Additionally, the FDA approved Leqembi Iqlik subcutaneous autoinjector for weekly initiation treatment in early Alzheimer's disease, leading to a US launch in August. BioArctic also entered into a research collaboration in oncology with the Swedish biotech company Mesenkia Therapeutics to explore a novel antibody-based treatment for glioblastoma. Net revenues for the quarter amounted to SEK 247.5 million, with royalty income from Leqembi at SEK 179.4 million, while operating profit was SEK -6.5 million and earnings per share before dilution were SEK -0.13.

Eisai reported that its first-quarter profit attributable to owners of the parent increased 26.0% to 18.24 billion yen from 14.47 billion yen a year earlier. Operating profit rose 19.2% to 24.73 billion yen, while revenue grew 15.6% to 234.33 billion yen for the three months ended June 30, 2026. For the full fiscal year 2026, the company projects revenue of 883.5 billion yen, operating profit of 70 billion yen, and profit for the year of 54 billion yen. Eisai shares were trading at 4,656 yen on the Tokyo Stock Exchange, down 3.56%.

Global sales of Leqembi totaled 29.3 billion yen in the second quarter of 2026, generating a royalty of 179 million Swedish kronor for BioArctic, an increase of approximately 10 percent compared to the second quarter of 2025. The prior-year quarter included a one-time stockpiling effect in the Chinese market of around 5.3 billion yen; excluding that effect, royalty revenues grew approximately 43 percent year-over-year. The figures were reported by BioArctic's partner Eisai alongside Biogen's second-quarter results.

Nvidia CEO Jensen Huang unveiled a broad slate of AI products, partnerships, and customer deployments at the company's Japan AI event in Tokyo on July 15. The announcements spanned physical AI, healthcare, financial services, quantum computing, automotive, manufacturing, and gaming, highlighting Nvidia's push to position its technologies at the forefront of Japan's next-generation AI infrastructure. In physical AI and robotics, Nvidia launched Cosmos 3 Edge for on-device vision reasoning, and companies including FANUC, Fujitsu, Hitachi, Kawasaki Heavy Industries, Kubota, NEC, SoftBank, Sony Group, and Yaskawa Electric plan to join the Nvidia Cosmos Coalition to develop open physical AI models. In healthcare, Astellas Pharma, Eisai, Daiichi Sankyo, Ono Pharmaceutical, and Takeda Pharmaceutical are deploying Nvidia BioNeMo for AI-powered drug discovery, while Canon and Fujifilm introduced Nvidia-powered next-generation CT systems, and Kawasaki Heavy Industries is advancing AI-enabled surgical and hospital robots. In financial services, Mizuho Financial plans Japan's largest on-premises AI factory for banking, Sumitomo Mitsui Financial has deployed an AI factory through Japan Research Institute, and Rakuten Bank is developing AI transaction foundation models using Nvidia Agent Toolkit. Huang emphasized that the next wave of AI will be physical AI—robots, factories, vehicles, and industrial systems that can perceive, reason, and act in the real world—and said Japan's leadership in robotics, manufacturing, and precision engineering positions it to play a leading role in this transition.

Biogen and Eisai announced that nearly 83% of early Alzheimer's disease patients treated with LEQEMBI remained stable or improved over an average of 17 months in the real-world LEADER study. The interim analysis of 432 patients found 75.9% stayed in the same disease stage and 6.6% transitioned from mild dementia back to mild cognitive impairment. The three-year multicenter retrospective study across 13 U.S. sites integrates patient charts, electronic medical records, and provider surveys to assess treatment persistence and outcomes. LEQEMBI is an antibody targeting amyloid beta that aims to slow cognitive decline by removing insoluble plaque and soluble protofibrils.

Biogen shares rose nearly 5% after the FDA approved a subcutaneous autoinjector version of Leqembi as an initiation dosing option for early Alzheimer's disease. The new formulation, marketed as Leqembi Iqlik, allows patients to start treatment with a once-weekly injection that takes about 15 seconds, eliminating the need for biweekly hour-long intravenous infusions during the initiation phase. Biogen plans to launch the product commercially by the end of next month. The approval is supported by clinical data showing drug exposure equivalent to the intravenous version. Leqembi, developed in collaboration with Japan-based Eisai, was initially approved in 2023 as a biweekly intravenous medication.

The US FDA has approved a subcutaneous version of Biogen and Eisai's Alzheimer's treatment Leqembi, called Leqembi Iqlik, for initiation and maintenance dosing, including at-home use. The initiation dose is 500 mg once weekly via two 250 mg injections, each lasting about 15 seconds, with maintenance dosing of 360 mg once weekly after 18 months. Patients can switch between the subcutaneous and intravenous versions of lecanemab during their therapy. Approval was supported by data showing the subcutaneous version had similar efficacy to the IV version.

The U.S. Food and Drug Administration has approved a once-weekly subcutaneous injection of LEQEMBI IQLIK as an initiation dose for early Alzheimer’s disease, making it the first anti-amyloid treatment worldwide to offer at-home dosing from the start of therapy. The approved initiation regimen is 500 milligrams given weekly as two 250-milligram injections via an autoinjector, with each injection delivered in approximately 15 seconds; patients may also use LEQEMBI IQLIK for maintenance dosing at 360 milligrams weekly after 18 months of intravenous or subcutaneous treatment. The approval is supported by sub-studies within the Phase 3 Clarity AD long-term extension showing that once-weekly subcutaneous administration achieved exposure equivalent to intravenous dosing, with a similar safety profile and comparable rates of amyloid-related imaging abnormalities. Eisai and Biogen plan a U.S. launch of LEQEMBI IQLIK as an initiation dose in late August 2026, with the product distributed through specialty pharmacies. LEQEMBI is indicated for adults with mild cognitive impairment or mild dementia due to Alzheimer’s disease, collectively referred to as early Alzheimer’s disease.

Nuvation Bio announced that the UK drug regulator has accepted the marketing application for its lung cancer drug taletrectinib, which targets advanced ROS1-positive non-small cell lung cancer. The application was submitted by Nuvation Bio's partner Eisai. The drug has already secured marketing approvals in the US, Japan, and China, and the company is now seeking approval in the UK and other international markets. Nuvation Bio exited the first quarter of 2026 with 533.7 million dollars in cash, cash equivalents, and marketable securities, and recently raised 287.5 million dollars through a notes offering.

Nuvation Bio announced that its partner Eisai's Marketing Authorisation Application for taletrectinib in advanced ROS1-positive non-small cell lung cancer was validated by the U.K. MHRA under the International Recognition Procedure. This adds to an already validated application with the European Medicines Agency and planned filings in Canada and other regions. Taletrectinib is already approved as IBTROZI in the U.S., Japan and China, and this regulatory momentum could extend Nuvation Bio's reach into additional ROS1-positive lung cancer markets through Eisai's licensed territories. The company recently raised US$250.0 million in convertible notes due 2032 to fund international filings and long-running glioma studies, though this adds potential future dilution. Analysts project Nuvation Bio could reach $427.2 million in revenue and $5.2 million in earnings by 2028, requiring 151.8% yearly revenue growth.

Eisai will present new clinical and real-world evidence on lecanemab at the Alzheimer's Association International Conference in London from July 12 to 15. The presentations will cover the subcutaneous formulation, long-term use across diverse patient groups, maintenance dosing, and at-home administration. Key data include results from the LEADER study evaluating real-world lecanemab use in diverse US clinical settings three years post-approval, including maintenance dosing with IV treatment every four weeks and the first reported findings of at-home subcutaneous administration. Additional presentations will address the Phase 3 AHEAD 3-45 study in preclinical Alzheimer's disease, treatment actions following ARIA in a Japanese post-marketing study, sex-based outcomes from the LEADER study, and tau biomarker changes in the CLARITY-AD trial. BioArctic will also participate in a plenary session on the prevalence of Alzheimer's disease pathology in the community.