Articles from Takeda Pharmaceutical Company Limited

Takeda (TSE:4502/NYSE:TAK) will host an investor R&D Day today beginning at 8:30 a.m. JST in Tokyo. The meeting will focus on programs in the company’s late-stage pipeline, the transformative value they could deliver to patients, and the market opportunities they represent.

Takeda (TSE:4502/NYSE:TAK) today announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. (Nasdaq: KROS) to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau.

Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first half of fiscal year 2024 (six months ended September 30, 2024), with continued momentum in its Growth & Launch Products driving growth. The company has upgraded its full year forecasts and Management Guidance to reflect stronger than anticipated first-half performance (including milder than anticipated generic erosion of VYVANSE® in the U.S.) and revised foreign exchange assumptions.

Takeda (TOKYO:4502/NYSE:TAK) and Boston Medical Center (BMC) today announced a new collaboration focused on identifying innovative solutions that can reduce hard-to-abate greenhouse gas (GHG) emissions in the health care sector. The collaboration between Takeda and BMC aims to reduce the GHG emissions caused by disposal of regulated medical waste, such as pharmaceutical packaging and single-use plastics, which are among the most difficult environmental challenges facing the industry. The effort will also seek to scale the interventions developed through the collaboration by sharing best practices to help other organizations adopt and learn new ways to decarbonize in their operations to drive wider health care ecosystem impact.

Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

Takeda (TSE:4502/NYSE:TAK) will present additional data from the Phase 2b trials (TAK-861-2001,TAK-861-2002) and long-term extension (LTE) study (TAK-861-2003) of TAK-861 in narcolepsy type 1 (NT1) and narcolepsy type 2 (NT2) at Sleep Europe 2024, the 27th Congress of the European Sleep Research Society (ESRS), being held September 24-27, 2024 in Seville, Spain. TAK-861 is an investigational oral orexin receptor 2 (OX2R) selective-agonist designed to address the orexin deficiency in NT1 by selectively stimulating the orexin receptor 2. TAK-861 has the potential to be the first treatment to address the underlying pathophysiology of NT1. Based on the positive Phase 2b trial results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating the efficacy and safety of TAK-861 in adults with NT1.

Takeda (TOKYO:4502/NYSE: TAK) today committed JPY4.6 billion (Approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to improving health systems resiliency in low and middle-income countries around the world. This commitment demonstrates Takeda’s focus on tackling systemic disparities and supporting local leadership in strengthening health infrastructure, empowering health workforce, and increasing local knowledge and capacity to improve equitable and sustainable healthcare access and delivery.

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved ADZYNMA®▼ (recombinant ADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with congenital thrombotic thrombocytopenic purpura (cTTP).3 ADZYNMA is now the first and only enzyme replacement therapy in the European Union (EU) specifically for the treatment of cTTP.3,4 This approval includes confirmation of orphan medicinal product designation and follows a positive opinion from the Committee for Medicinal Products for Human Use, as announced by the company on May 31, 2024.

Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first quarter of fiscal year 2024 (period ended June 30, 2024), with continued momentum in its Growth & Launch Products driving Core growth at CER and more than offsetting revenue impact resulting from significant losses of exclusivity that occurred in the previous fiscal year.

Takeda (TOKYO:4502/NYSE:TAK) has announced new assignments of directors, determined at the Board of Directors meeting and at the Audit and Supervisory Committee meeting, following the 148th Ordinary Meeting of Shareholders, held in Osaka today.

Takeda (TSE:4502/NYSE:TAK) today announced that LIVTENCITY® (maribavir) has been approved by the Japanese Ministry of Health, Labour and Welfare (MHLW) for post-transplant cytomegalovirus (CMV) infection/disease that is refractory to existing anti-CMV therapies.4 LIVTENCITY is the first and only post-transplant anti-CMV treatment approved in Japan that targets and inhibits pUL97 kinase and its natural substrates.1

Takeda (TSE:4502/NYSE:TAK) today presented positive results from its Phase 2b, randomized, double-blind, placebo-controlled study evaluating the safety, tolerability and efficacy of mezagitamab (TAK-079) in patients with persistent or chronic primary immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder. ITP is characterized by the accelerated destruction of platelets in blood, resulting in a decreased platelet count and an increase of bleeding that can be debilitating. These data (Abstract #LB 01.1) were presented at the oral Late-Breakthrough Session at the 32nd Congress of the International Society on Thrombosis and Haemostasis (ISTH) in Bangkok, Thailand. Takeda plans to initiate a global Phase 3 trial of mezagitamab in patients with ITP in the second half of FY2024.

Takeda (TSE:4502/NYSE:TAK) today announced that the European Commission (EC) approved FRUZAQLA (fruquintinib) as a monotherapy indicated for the treatment of adult patients with metastatic colorectal cancer (mCRC) who have been previously treated with available standard therapies, including fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapies, anti-VEGF agents, and anti-EGFR agents, and who have progressed on or are intolerant to treatment with either trifluridine-tipiracil or regorafenib. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on April 25, 2024, and approval by the U.S. Food and Drug Administration (FDA) for adults with mCRC who have been previously treated with oxaliplatin- and irinotecan-based regimens on November 8, 2023.1,2

Takeda (TSE:4502/NYSE:TAK) today announced data from the Phase 3 ADVANCE-CIDP 3 clinical trial, a long-term extension study evaluating the safety and efficacy of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with chronic inflammatory demyelinating polyneuropathy (CIDP). Results showed favorable long-term safety and tolerability of HYQVIA, and a low relapse rate, supporting its use as maintenance treatment for CIDP. These findings will be presented in a poster session on Sunday, June 23, 2024 at the Peripheral Nerve Society (PNS) Annual Meeting in Montreal, Canada.

Takeda (TSE:4502/NYSE:TAK) today announced topline data from its SKYLINE and SKYWAY studies.

Takeda (TSE:4502/NYSE:TAK) today announced the signing of an option agreement with Ascentage Pharma to enter into an exclusive license agreement for olverembatinib, an oral, potentially best-in-class, third-generation BCR-ABL tyrosine kinase inhibitor (TKI), which is currently in development for chronic myeloid leukemia (CML) and other hematological cancers. If exercised, the option would allow Takeda to license global rights to develop and commercialize olverembatinib in all territories outside of mainland China, Hong Kong, Macau, Taiwan and Russia.

Takeda (TSE:4502/NYSE:TAK) announced that it has expanded its partnership with Partners In Health (PIH), an international nonprofit organization, to support a new initiative with PIH that aims to address social determinants of health and improve access to care within communities across Massachusetts. This builds on Takeda’s existing global partnership with PIH that has been in place since 2017.

Takeda (TSE: 4502/NYSE:TAK) will present today positive results from its Phase 2b trial of TAK-861 in narcolepsy type 1 (NT1) as late-breaking data presentations at SLEEP 2024, the 38th annual meeting of the American Academy of Sleep Medicine and the Sleep Research Society. TAK-861 is an investigational oral orexin receptor 2 (OX2R) agonist and, based on the results, has the potential to provide transformative efficacy in addressing the overall disease burden in people with NT1​. The randomized, double-blind, placebo-controlled, multiple dose trial, TAK-861-2001 (NCT05687903), in 112 patients with NT1 demonstrated statistically significant and clinically meaningful improvements across primary and secondary endpoints, with efficacy sustained over 8 weeks of treatment.*

Takeda (TSE:4502/NYSE:TAK) and Pfizer (NYSE: PFE) today announced that the German Hodgkin Study Group (GHSG) will present positive results from the Phase 3 HD21 trial evaluating ADCETRIS® (brentuximab vedotin) in combination with chemotherapy as a late-breaking oral presentation at the 60th American Society of Clinical Oncology (ASCO) Annual Meeting (LBA7000) and at the 29th European Hematology Association (EHA) Annual Meeting (S225). The four-year analysis presented by the GHSG showed superior progression-free survival (PFS) and improved tolerability for patients compared to a current standard of care regimen used in Europe in this setting.

Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval, under exceptional circumstances, of recombinant ADAMTS13 (rADAMTS13) for the treatment of ADAMTS13 deficiency in children and adult patients with cTTP. The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for rADAMTS13 throughout the European Union (EU). If approved, rADAMTS13 will be the first and only enzyme replacement therapy in the EU for the treatment of cTTP.3

Takeda (TSE: 4502/NYSE:TAK) today announced that it will present data from its oncology pipeline and product portfolio at the 60th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held May 31-June 4, 2024, in Chicago, Ill.

Takeda (TSE:4502/NYSE:TAK) and AC Immune SA (NASDAQ: ACIU) today announced an exclusive, worldwide option and license agreement for AC Immune’s active immunotherapies targeting toxic forms of amyloid beta (Abeta), including ACI-24.060 for the treatment of Alzheimer’s disease.

Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for fiscal year 2023 (period ended March 31, 2024), delivering its Management Guidance for Core Operating Profit and exceeding its Management Guidance for Revenue and Core EPS performance at CER, in a year of significant loss-of-exclusivity impact.

Takeda (TSE:4502/NYSE:TAK) today announced that the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of fruquintinib, a selective inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated metastatic colorectal cancer (mCRC). The European Commission (EC) will consider the CHMP positive opinion when determining the potential marketing authorization for fruquintinib for mCRC throughout the European Union (EU), Norway, Liechtenstein and Iceland. If approved, fruquintinib will be the first and only selective inhibitor of all three VEGF receptors approved in the EU for previously treated mCRC.1,2

Takeda (TSE:4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has approved ENTYVIO® (vedolizumab) subcutaneous (SC) administration for maintenance therapy in adults with moderately to severely active Crohn’s disease (CD) after induction therapy with intravenous (IV) ENTYVIO.1 The subcutaneous administration of ENTYVIO was also approved by FDA in September 2023 for the maintenance treatment of adults with moderately to severely active ulcerative colitis (UC) and is available in the U.S. as a single-dose prefilled pen (ENTYVIO Pen).*