Welcome to our dedicated page for Takeda Pharmaceutical Company news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharmaceutical Company stock.
Takeda Pharmaceutical Company Limited (NYSE: TAK), a Japanese multinational corporation, stands as Asia's largest and one of the globe's top 20 pharmaceutical giants by revenue. Headquartered in Tokyo, Takeda operates across approximately 80 countries, merging American and British roots into its vast global presence.
With a revenue of JPY 4.3 trillion in fiscal 2023, Takeda dedicates its efforts predominantly to five therapeutic areas: oncology, gastroenterology, neuroscience, rare diseases, and plasma-derived therapies, which collectively generate more than 80% of its revenue. Takeda’s global footprint is diversified, with 50% of its revenue originating from the US, 20% from Japan, and another 20% from Europe and Canada.
Noteworthy for its robust pipeline and commitment to innovation, Takeda partners with various organizations to push the boundaries of medical research. A recent highlight includes a joint venture with Astellas Pharma Inc. and Sumitomo Mitsui Banking Corporation. This collaboration aims to incubate early drug discovery programs, striving to transition academic breakthroughs into practical medical treatments.
Moreover, Takeda's strategic partnership with Neurocrine Biosciences to develop NBI-1065845, an investigational treatment for major depressive disorder, showcases its dedication to addressing unmet medical needs. The positive Phase 2 results of the SAVITRI™ study underline the potential of NBI-1065845 to provide hope for patients with inadequate responses to existing treatments.
Takeda's philosophy focuses on creating a healthier world through life-transforming treatments in its core areas. Their values-based, R&D-driven approach has sustained their leadership in the pharmaceutical sector for over two centuries.
Takeda has announced new director assignments, decided at the Board of Directors and Audit and Supervisory Committee meetings following the 148th Ordinary Meeting of Shareholders. The Board is composed of 11 external directors out of 14 total members, ensuring transparency and objectivity.
An external director will continue to chair the Board. The Audit and Supervisory Committee, Nomination Committee, and Compensation Committee will be composed solely of external directors.
The new assignments include Christophe Weber as Representative Director and CEO, Milano Furuta as Director and CFO, and Andrew Plump as Director of R&D. External directors such as Masami Iijima, Ian Clark, and Steven Gillis hold various roles, ensuring robust governance.
These changes are effective from June 26, 2024, and emphasize Takeda's commitment to strong, independent governance.
Takeda announced the Japanese Ministry of Health, Labour and Welfare's approval of LIVTENCITY® (maribavir) for post-transplant cytomegalovirus (CMV) infection/disease resistant to existing anti-CMV therapies. LIVTENCITY is the first and only post-transplant treatment in Japan that targets pUL97 kinase. The approval is based on Phase 3 SOLSTICE trial results, which demonstrated significant improvement with maribavir over alternative treatments in clearing CMV viremia by Week 8. The trial included 235 maribavir patients and 117 on alternative treatments, with adverse reactions in 60.3% of maribavir patients. An additional Japanese Phase 3 study showed 33.3% efficacy at clearing CMV viremia by Week 8, with adverse reactions in 36.6% of patients.
Takeda unveiled positive results from its Phase 2b study of mezagitamab (TAK-079) in treating persistent or chronic primary immune thrombocytopenia (ITP). The study showed rapid and sustained platelet increases among patients receiving mezagitamab, with effects persisting for eight weeks post-treatment.
Among patients treated with the 600mg dose, 81.8% achieved complete platelet response, 90.9% achieved clinically meaningful platelet response, and 100% achieved hemostatic platelet response. Adverse events (AEs) were lower in the mezagitamab group compared to placebo. Takeda plans to initiate a Phase 3 trial in the second half of FY2024.
Takeda has received European Commission (EC) approval for FRUZAQLA (fruquintinib) as a treatment for adult patients with metastatic colorectal cancer (mCRC) who have exhausted other standard therapies. This approval follows the Phase 3 FRESCO-2 trial, which demonstrated significant efficacy and a manageable safety profile for FRUZAQLA. The EC decision was preceded by a positive opinion from the CHMP on April 25, 2024, and an FDA approval on November 8, 2023. FRUZAQLA is now the first new targeted therapy for mCRC in the EU in over a decade, providing a new option for patients regardless of their biomarker status.
Takeda has shared long-term data from the Phase 3 ADVANCE-CIDP 3 clinical trial, evaluating HYQVIA for treating chronic inflammatory demyelinating polyneuropathy (CIDP). The study, the longest of its kind, demonstrated HYQVIA's safety, tolerability, and low relapse rate, supporting its use as maintenance therapy. Presented at the PNS Annual Meeting, HYQVIA is the first facilitated subcutaneous immunoglobulin for CIDP, approved by the FDA and European Commission. The trial involved 85 patients over 33 months, reporting consistent safety profiles with no new concerns. Adverse events were mostly mild or moderate, with serious events in three patients. Results indicated stable disease maintenance with a low annualized relapse rate of 4.5%.
Takeda has released topline results from two Phase 3 studies for its drug soticlestat (TAK-935) targeting Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS). The SKYLINE study for DS narrowly missed its primary endpoint of reducing convulsive seizure frequency but showed significant effects in multiple secondary endpoints. The SKYWAY study for LGS missed its primary endpoint of reducing Major Motor Drop seizures. Despite the mixed results, soticlestat was well tolerated in both studies. Takeda plans to discuss the data with regulatory authorities and assess the financial impacts, including potential impairment losses.
Takeda has signed an option agreement with Ascentage Pharma for an exclusive global license to olverembatinib, a third-generation BCR-ABL tyrosine kinase inhibitor (TKI) for treating chronic myeloid leukemia (CML) and other hematological cancers.
The agreement gives Takeda the option to license and commercialize olverembatinib outside of mainland China, Hong Kong, Macau, Taiwan, and Russia. Ascentage Pharma will continue late-stage clinical development before Takeda exercises the option.
Ascentage Pharma will receive a $100 million option payment, a potential option exercise fee, and additional milestone and royalty payments. Takeda will also make a minority equity investment in Ascentage Pharma. Olverembatinib has shown promising clinical results, addressing a significant unmet need for CML patients resistant to current TKIs.
Takeda has announced an expanded partnership with Partners In Health (PIH) to support a new initiative aimed at addressing social determinants of health and improving access to care in Massachusetts. This initiative builds on Takeda's global partnership with PIH, which began in 2017 and has provided screening and diagnostic services to over 8 million people. The expanded collaboration will focus on establishing Health Equity Communities of Practice, expanding local health departments' capacity, and increasing opportunities for community health workers. This effort aims to dismantle systemic barriers to health equity and strengthen the health workforce in diverse communities across Massachusetts.
Takeda presented positive Phase 2b trial results for TAK-861, an oral orexin receptor 2 agonist, in treating narcolepsy type 1 (NT1) at SLEEP 2024. The trial showed statistically significant and clinically meaningful improvements across primary and secondary endpoints over 8 weeks, including increased sleep latency and reduced cataplexy. TAK-861 was generally safe and well tolerated, with no serious adverse events. The Phase 3 trials are set to commence in the first half of FY 2024. The FDA has granted Breakthrough Therapy designation to TAK-861 for excessive daytime sleepiness in NT1.
Takeda and Pfizer announced positive four-year results from the Phase 3 HD21 trial. The trial evaluated ADCETRIS® (brentuximab vedotin) in combination with chemotherapy for treating newly diagnosed Stage IIb/III/IV classical Hodgkin lymphoma. Conducted by the German Hodgkin Study Group (GHSG), the study showed that the ADCETRIS combination significantly improved progression-free survival (PFS) and had a better safety profile compared to the standard eBEACOPP regimen. The results will be presented at the ASCO and EHA 2024 meetings. After 48 months, the ADCETRIS combination showed a 94.3% PFS rate versus 90.9% for eBEACOPP. Additionally, the ADCETRIS regimen was associated with fewer acute and long-lasting toxicities. Takeda and Pfizer are responsible for regulatory filings and commercialization in different regions.
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