Welcome to our dedicated page for Takeda Pharm news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharm stock.
The TAK news page on Stock Titan aggregates company-specific coverage for Takeda Pharmaceutical Company Limited American Depositary Shares (NYSE: TAK). Takeda’s own disclosures describe it as a values-based, R&D-driven biopharmaceutical company headquartered in Japan, with core therapeutic and business areas in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Because of this broad focus and active pipeline, Takeda generates frequent news across clinical, regulatory, partnership and financial topics.
Recent press releases highlight late-stage clinical data and regulatory plans for several key programs. In neuroscience, Takeda has presented Phase 3 results for oveporexton (TAK-861), an investigational oral orexin receptor 2 agonist for narcolepsy type 1, showing statistically significant improvements in excessive daytime sleepiness, cataplexy and quality-of-life measures versus placebo. In immunology and dermatology, the company has reported pivotal Phase 3 data for zasocitinib (TAK-279), an investigational highly selective oral TYK2 inhibitor in moderate-to-severe plaque psoriasis, with studies meeting all primary and ranked secondary endpoints.
Takeda news also covers hematology and rare disease developments. Together with Protagonist Therapeutics, the company has released Phase 3 VERIFY and long-term THRIVE data for rusfertide, an investigational hepcidin mimetic for polycythemia vera, demonstrating durable hematocrit control, reduced phlebotomy requirements and maintained patient-reported outcome improvements. In nephrology, Takeda has shared Phase 1b data for mezagitamab (TAK-079) in primary IgA nephropathy, showing stable kidney function and sustained reductions in proteinuria and Gd-IgA1 levels up to 18 months after the last dose.
In vaccines, Takeda has announced seven-year Phase 3 TIDES trial data for its dengue vaccine QDENGA (TAK-003), reinforcing sustained protection against virologically confirmed dengue and dengue-related hospitalizations and supporting a two-dose regimen. Corporate and pipeline news includes strategic oncology collaborations, such as the global partnership with Innovent Biologics for late-stage assets IBI363 and IBI343, and financial updates on revenue trends, generic erosion impacts and revised full-year forecasts.
Investors and followers of TAK can use this news feed to track Takeda’s clinical milestones, regulatory filings, strategic alliances, portfolio prioritization decisions and IFRS-based financial disclosures as they are reported in press releases and SEC Form 6-K submissions.
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.
Takeda has received a positive opinion from the EMA's CHMP for recombinant ADAMTS13 (rADAMTS13) for treating congenital thrombotic thrombocytopenic purpura (cTTP).
If approved, rADAMTS13 will be the first enzyme replacement therapy for cTTP in the EU. cTTP is an ultra-rare blood clotting disorder with a high mortality rate if untreated.
This recommendation is based on comprehensive evidence, including results from a Phase 3 trial, published in May 2024. The European Commission will now consider this opinion for potential marketing authorization in the EU.