Japanese pharmaceutical company headquartered in Bunkyo, Tokyo, with roughly 10,000 employees including about 1,500 in research; listed on the Tokyo Stock Exchange, with a focus on oncology and neurology.
Clinical Trials
383
11 active
Approvals
15
Total approvals
Agencies
3
Regulatory bodies
Founded
1941
Active, not recruiting
7
1.8%
Completed
248
64.8%
Not yet recruiting
4
1.0%
Recruiting
20
5.2%
Terminated
3
0.8%
Withdrawn
3
0.8%
- The FDA approved a supplemental New Drug Application for taletrectinib (IBTROZI), updating the label with a median duration of response of 49.7 months in TKI-naive ROS1-positive NSCLC. - Updated data from the phase 2 TRUST-I and TRUST-II trials reflect a median follow-up of 51 months in TRUST-I plus 14 additional months of follow-up. - The approval arrived four months ahead of the January 4, 2027 PDUFA date, with no changes to safety labeling and no new safety signals identified. - Nuvation Bio reported median progression-free survival of 49.6 months and a 3-year overall survival rate of 65.3% in the TKI-naive population.
- Eisai and Biogen announced Japan's approval of LEQEMBI Pen, a subcutaneous autoinjector formulation of lecanemab, as a new route of administration for early Alzheimer's disease. - The approval makes Japan the third country globally to clear the subcutaneous formulation, following the United States in July 2026 and China in September 2026. - Two pens totaling 500 mg are given once weekly, with each injection taking about 15 seconds and demonstrating exposure similar to biweekly intravenous dosing. - Systemic injection-related reactions occurred less frequently with subcutaneous administration at 1.4% compared with intravenous administration, with ARIA monitoring by MRI unchanged.
- China's National Medical Products Administration has approved a self-administered subcutaneous formulation of LEQEMBI for early Alzheimer's disease, developed by Biogen and partner Eisai. - The new option allows once-weekly at-home dosing via an autoinjector instead of clinic-based infusions, for patients with early-stage Alzheimer's who qualify under the label. - China is only the second country worldwide to clear the at-home subcutaneous version of LEQEMBI, according to Simply Wall St.
- BioArctic and Eisai said Leqembi Iqlik, a subcutaneous autoinjector form of lecanemab, is now available in the US for initiation therapy after FDA approval on 13 July. - The starting dose is 500 mg given as two 250 mg injections of about 15 seconds each, replacing the biweekly intravenous infusions previously required in a clinic. - It is the first anti-amyloid treatment cleared for at-home dosing at both treatment initiation and maintenance, with MRI monitoring still required to watch for ARIA.
- Biogen reported Q2 2026 adjusted earnings of $3.60 per share on revenue of $2.74 billion, surpassing analyst estimates of $2.95 and $2.46 billion respectively. - The company raised its full-year 2026 revenue guidance to mid-single-digit growth from a prior forecast of mid-single-digit decline, citing rare disease portfolio strength. - Global sales of Alzheimer's drug Leqembi rose 15% year-over-year to approximately $184 million, with a new subcutaneous formulation expected to boost uptake. - Biogen cut its 2026 adjusted EPS guidance to $12–$13 from $14.25–$15.25, reflecting a $3.85 per share impact from the $5.6 billion Apellis Pharmaceuticals acquisition.
- CORE Biomedicine completed a $21 million Series A financing co-led by UTokyo Innovation Platform and Elikon Venture to advance lineage-based precision oncology therapeutics. - The company's Japanese subsidiary received a competitive AMED grant under the Strengthening Program for Pharmaceutical Startup Ecosystem to support R&D activities. - CORE signed an exclusive global licensing agreement with Eisai for multiple preclinical oncology programs targeting key molecular drivers across various cancers. - The combined financing and licensing portfolio position CORE to accelerate discovery and early clinical development of next-generation cancer therapies for broader patient populations.
- Eisai's dual orexin receptor antagonist lemborexant has had its marketing authorization application accepted for evaluation by both the UK's MHRA and the European Medicines Agency. - Lemborexant targets the orexin neurotransmitter system to facilitate sleep onset and maintenance, offering a novel mechanism distinct from widely used sedating CNS medications. - Chronic insomnia affects approximately 6.8–14.8% of adults in the UK and 4.7–22.1% in Europe, representing a significant unmet medical need with considerable impact on daytime functioning. - The drug is already approved in over 25 countries including Japan, the United States, Canada, Australia, and China.
- C-BRAIN, a 17-member global consortium led by WashU Medicine, launched three open-source AI tools at the Alzheimer's Association International Conference in London to accelerate neurodegenerative disease drug development. - The tools — AI Literature and Data Synthesis, Dark Data Analyzer, and Reviewer Three — address the reality that more than 99% of Alzheimer's drug candidates fail in clinical trials. - A federated design allows pharmaceutical partners including Bristol Myers Squibb, Johnson & Johnson, and Sanofi to contribute proprietary data without exposing intellectual property. - All three tools are freely available to biomedical researchers in neurodegeneration, with the full codebase open-sourced to ensure transparency and community-driven improvement.
- University College London and Eisai have signed a five-year extension to their drug discovery collaboration, continuing the partnership through 2030 to tackle Alzheimer's, Parkinson's, and ALS. - The alliance has already produced the anti-MTBR tau antibody E2814, now in Phase II/III trials for dominantly inherited Alzheimer's disease and Phase II for sporadic early AD. - Eight drug discovery projects have been supported through £10 million in investment to date, with further funding committed over the next five years. - The partnership has generated more than 30 scientific publications and presentations, emphasizing knowledge exchange alongside therapeutic development.
- Nuvation Bio's Ibtrozi, a ROS1 TKI for NSCLC, demonstrated a 90% response rate and 50-month duration of response, which CEO David Hung calls the highest combined rate ever seen for any drug in any cancer. - The company's brain tumor drug safusidenib showed a 44% response rate in low-grade glioma and striking complete responses in high-grade glioma, including a glioblastoma patient tumor-free for over three years. - Nuvation Bio is well capitalized with over $535 million in cash and used a royalty financing strategy, selling 5% of Ibtrozi U.S. sales for $150 million to fund development. - A novel drug-drug conjugate (DDC) platform is in development, designed to overcome limitations of antibody-drug conjugates by using two conjugated small molecules for improved tumor targeting.
