Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of - TAK STOCK NEWS

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. Currently, no approved prophylactic treatments exist for children under 6. If approved, TAKHZYRO would be the first treatment available for this demographic. The FDA has granted priority review, with a decision expected in the first half of 2023.

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.