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.
The European Commission has approved QDENGA (TAK-003), a dengue vaccine for individuals aged four years and older. This makes QDENGA the only dengue vaccine approved in the EU for use, regardless of prior dengue exposure.
Approval is based on extensive clinical studies involving over 28,000 participants, showing 80.2% efficacy in preventing symptomatic dengue and 90.4% in preventing hospitalizations at 18 months. The vaccine is crucial for reducing dengue incidence, which has significantly risen globally. No changes are expected in Takeda's fiscal outlook for FY 2022 due to this approval.
Takeda has announced that the FDA has accepted the Biologics License Application (BLA) for TAK-003, its investigational dengue vaccine. The vaccine is aimed at preventing dengue disease caused by any virus serotype in individuals aged 4 to 60. With increasing dengue incidence and 888 infections reported in the U.S. this year, 96% of which were travel-related, the vaccine could become a crucial preventive option. The BLA is supported by a pivotal Phase 3 trial showing 80.2% efficacy at 12 months. Approval in Indonesia has been achieved, with ongoing regulatory reviews in Europe and other regions.
Takeda announced the successful results of the Phase 3 PhALLCON trial, which compared ICLUSIG® (ponatinib) with imatinib in adults with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL). The trial met its primary endpoint, demonstrating superior rates of minimal residual disease (MRD)-negative complete remission for ICLUSIG. Given the urgency for effective therapies in this patient population, these findings highlight ICLUSIG’s potential in addressing treatment challenges associated with Ph+ ALL.
LIVTENCITY is now the first and only treatment for cytomegalovirus (CMV) infection approved by the European Commission (EC) for patients with post-transplant infections. CMV is a prevalent issue post-transplant, affecting 16-56% of solid organ transplant patients. The approval is based on the successful results of the Phase 3 SOLSTICE trial. LIVTENCITY targets the UL97 protein kinase, offering a novel option where previous therapies failed, enabling healthcare providers across the EU and EEA to manage refractory CMV cases effectively.
Takeda reported strong financial results for the first half of fiscal year 2022, with core revenue growth of 5.5% at constant exchange rates (CER) and reported revenue growth of 10.1%. Core operating profit grew 14.5% at CER, achieving a core operating profit margin of 31.7%. The company upgraded its peak sales outlook for ENTYVIO® to $7.5-9.0 billion and improved net debt to adjusted EBITDA to 2.6x. Takeda also reaffirmed its full-year guidance, reflecting strong performance in key business areas and ongoing product approvals.
Takeda has entered into a collaboration with Zedira and Dr. Falk Pharma to exclusively develop and commercialize TAK-227 (ZED1227) for celiac disease in the U.S. and other regions outside of Europe, Canada, Australia, and China. This investigational oral therapy aims to inhibit the immune response to gluten, addressing a significant unmet need in celiac disease treatment. The agreement adds a promising candidate to Takeda's pipeline, which already includes two other investigational therapies for celiac disease, both recently entering Phase 2 trials.
Takeda announced a positive opinion from the European Medicines Agency's CHMP for its dengue vaccine candidate, TAK-003. This recommendation supports the vaccine's use in individuals aged four and older across Europe and dengue-endemic countries. The decision is based on over 4.5 years of safety and efficacy data from a pivotal Phase 3 trial involving more than 20,000 participants. Marketing authorization in Europe is anticipated soon, with further regulatory reviews expected in Latin America and Asia.
Takeda has announced that the FDA has accepted a supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO (lanadelumab-flyo) to prevent hereditary angioedema (HAE) attacks in pediatric patients aged 2 to 12 years old.
Takeda and UNITAR have launched a joint initiative to enhance healthcare systems for plasma and plasma-derived therapies. This partnership aims to address the rising global demand for these therapies due to increasing patients with rare diseases. The initiative seeks to create a UN-based platform to unite experts, policymakers, and stakeholders, improving access and quality of life for patients. Takeda will contribute its expertise and funding, working collaboratively with countries to develop solutions tailored to their healthcare challenges.
Takeda and Enel North America have signed a 12-year virtual power purchase agreement (VPPA) to advance Takeda's sustainability goals. The agreement is expected to generate approximately 350,000 Megawatt Hours (MWh) of renewable energy credits annually, covering around 20% of Takeda’s current Scope 1 and 2 GHG emissions. The VPPA facilitates the purchase of electricity from Enel’s 79 MW Seven Cowboy wind project in Oklahoma, ensuring a sustainable energy source for Takeda’s U.S. facilities. This aligns with Takeda's target to reduce GHG emissions by 40% by 2025 and achieve net-zero emissions by 2035.