Takeda Pharmaceutical

Takeda Pharmaceutical Co., Ltd. engages in the research and development, manufacture, import and export sale, and marketing of pharmaceutical drugs. It operates through the following segments: Prescription Drug, Consumer Healthcare, and Other. The Prescription Drugs segment includes the manufacture and sale of pharmaceutical products. The Consumer Healthcare segment includes the manufacture and sale of OTC drugs and quasi-drugs. The Other segment includes manufacture and sale of reagents, clinical diagnostics, and chemical products. The company was founded by Takeda Chobei on June 12, 1781 and is headquartered in Osaka, Japan.

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OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced late-breaking data from the Phase 3 GRAPHITE study presented at the 2023 Tandem Meetings, demonstrating vedolizumab achieved a statistically significant and clinically meaningful improvement in lower gastrointestinal (GI) aGvHD-free survival by Day 180 after allo-HSCT with no relevant differences in safety profile versus placebo.

Takeda Presents Positive Results from Phase 3 Study of Vedolizumab for Prevention of Intestinal Acute Graft-Versus-Host Disease (aGvHD) in Patients Undergoing Allogeneic Hematopoietic Stem Cell Transplantation (allo-HSCT)

BOSTON--(BUSINESS WIRE)--Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced the closing of Takeda's (TSE:4502/NYSE:TAK) acquisition of Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus, and its tyrosine kinase 2 (TYK2) inhibitor program, which includes the oral, selective allosteric TYK2 inhibitor NDI-034858, now known as TAK-279.

Nimbus Therapeutics Announces Closing of Takeda's Acquisition of TYK2 Subsidiary

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)--Takeda (TSE:4502/NYSE:TAK) today announced that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. (“Lakshmi”) from Nimbus Therapeutics, LLC (“Nimbus”), on February 8, 2023 (EST), as set forth in the share purchase agreement, following clearance from the United States Federal Trade Commission and a satisfaction of other closing conditions. The agreement had been announced on December 13, 2022: “Takeda to Acquire 100% Ownership of Nimbus Therapeutics' TYK2 Program Subsidiary”.

Takeda Completes Acquisition of Nimbus Therapeutics' TYK2 Program Subsidiary

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has approved the supplemental Biologics License Application (sBLA) for the expanded use of TAKHZYRO® (lanadelumab-flyo) for prophylaxis to prevent attacks of hereditary angioedema (HAE) in pediatric patients 2 to

U.S. FDA Approves Takeda's TAKHZYRO® (lanadelumab-flyo) to Prevent Hereditary Angioedema (HAE) Attacks in Children 2 Years of Age and Older

OSAKA, Japan--( BUSINESS WIRE )--Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the third quarter of fiscal year 2022 (period ended December 31, 2022).

Takeda Reinforces Long-term Growth Through Pipeline Advancement and Two Targeted Acquisitions; Delivers Another Strong Quarter in FY2022 Q3

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Hutchison China MediTech Ltd.

Takeda Pharmaceutical Co. Ltd. TAK, +0.43% 4502, +0.65% said Monday that it will acquire Hutchmed's HCM, +1.46% 13, +1.10% experimental cancer treatment outside mainland China, Hong Kong and Macau, with plans to develop and commercialize fruquintinib.

Takeda inks deal with Hutchmed for up to $1.1 billion

Shares in Hutchmed (China) Ltd jumped 6.5% after it announced a licensing deal with Takeda Pharmaceutical worth US$1.13bn. With an upfront payment of US$400mln plus milestones, the agreement allows the Japanese group to develop Hutchmed's cancer treatment, fruquintinib, outside China.

Hutchmed shares jump on US$1.13bn Takeda deal

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) today announced that it has entered into an exclusive licensing agreement with HUTCHMED (China) Limited (Nasdaq/AIM: HCM, HKEX: 13) and its subsidiary HUTCHMED Limited, for the further development and commercialization of fruquintinib outside of mainland China, Hong Kong and Macau.

Takeda To Acquire Exclusive Worldwide (ex-China) License of HUTCHMED's Fruquintinib, a Highly Selective, Oral VEGFR1/2/3 Tyrosine Kinase Inhibitor

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that, for the sixth consecutive year, it was one of only 15 companies to achieve global Top Employer® certification for 2023. In addition to the global certification, Takeda is also recognized as a Top Employer across 22 countries, strengthening its commitment to creating a diverse, equitable and inclusive working environment and an exceptional employee experience.

Takeda Named Global Top Employer for Sixth Consecutive Year

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Qitan Technology, a Chengdu nanopore sequencing company, completed a $101 million Series C round to support its commercialized nanopore devices. Takeda was approved to launch Exkivity (mobocertinib) in China to treat NSCLC patients with epidermal growth factor receptor (EGFR) Exon20 insertion mutations.

Week In Review: Qitan Raises $101 Million For Nanopore Sequencing Devices

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) today announced that EXKIVITY® (mobocertinib) has been approved by the National Medical Products Administration (NMPA) of China for the treatment of adult patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) Exon20 insertion mutations, whose disease has progressed on or after platinum-based chemotherapy. EXKIVITY has shown clinically meaningful and durable responses in patients with locally advanced or metastatic EGFR Exon20 insertion+ NSCLC and is now the first and only treatment available for this patient population in China. EXKIVITY, an oral tyrosine kinase inhibitor designed to target Exon20 insertions, was reviewed as part of the NMPA's Breakthrough Therapy program. Full approval for this indication may be contingent upon verification of clinical benefit in a confirmatory trial.

Takeda's EXKIVITY® (mobocertinib) Receives Approval from the NMPA of China, Becoming the First and Only Therapy Available for Patients with EGFR Exon20 Insertion+ NSCLC

Arrowhead Pharmaceuticals

OSAKA, Japan & CAMBRIDGE, Mass. & PASADENA, Calif.--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) and Arrowhead Pharmaceuticals Inc. (NASDAQ: ARWR) today announced topline results from the Phase 2 SEQUOIA clinical study of investigational fazirsiran (TAK-999/ARO-AAT) for the treatment of liver disease associated with alpha-1 antitrypsin deficiency (AATD-LD). The companies also provided an outline of a Phase 3 study that was co-developed by Takeda and Arrowhead and will be conducted by Takeda. Additional SEQUOIA study results are planned to be presented at a future medical meeting and submitted for publication. Arrowhead will host a webcast call for investors today, January 9, 2023, at 8:30 a.m. ET to review the Phase 2 data. To register for the webcast, visit the Events and Presentations page under the Investors section of www.arrowheadpharma.com.

Arrowhead and Takeda Announce Topline Results from SEQUOIA Phase 2 Study of Fazirsiran in Patients with Alpha-1 Antitrypsin Deficiency-Associated Liver Disease

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) today announced that the totality of evidence from a pre-planned interim analysis of a pivotal Phase 3 study supports the efficacy and safety of TAK-755 as enzyme replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare sub-type of thrombotic thrombocytopenic purpura (TTP), a rare, chronic and debilitating blood clotting disorder caused by a deficiency in ADAMTS13 protease.1,3 Acute TTP has a mortality rate of >90%, if left untreated.4

Takeda Announces Favorable Phase 3 Safety and Efficacy Results of TAK-755 as Compared to Standard of Care in Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

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OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) today announced that in the AURORA trial, a Phase 3, multicenter, randomized, double-blind, double-dummy, active-controlled study to assess the efficacy and safety of maribavir compared to valganciclovir for the treatment of CMV infection in hematopoietic stem cell transplant (HSCT) recipients, maribavir demonstrated clinically meaningful efficacy in confirmed CMV viremia clearance*, but did not meet its primary endpoint of non-inferiority vs. valganciclovir (maribavir 69.6% [190/273] vs. valganciclovir 77.4% [212/274]; adjusted difference, -7.7%; 95% CI: -14.98, -0.36), based on the prespecified non-inferiority margin of 7%. The primary endpoint was defined as the proportion of patients who achieved confirmed CMV viremia clearance (plasma CMV DNA

Takeda's Phase 3 AURORA Study Provides Evidence of Maribavir's Clinically Meaningful and Durable Effect in Cytomegalovirus (CMV) Infection in Hematopoietic Stem Cell Transplant Patients, Despite Missing Primary Endpoint

Entyvio is Takeda's key growth driver, and the management expects it to offset the effect of Vyvanse's patent expiration next year. The company aims to improve margins on its plasma-derived therapies (PDT) and is already seeing some signs in this regard.

Takeda: Late-Stage Pipeline Catalysts Approaching, But Vyvanse Patent Expiration Looms

BOSTON--( BUSINESS WIRE )--Nimbus Therapeutics, LLC (“Nimbus Therapeutics” or “Nimbus”), a clinical-stage company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, today announced that it has signed a definitive agreement under which Takeda (TSE:4502/NYSE:TAK) will acquire Nimbus Lakshmi, Inc., a wholly-owned subsidiary of Nimbus Therapeutics, and its tyrosine kinase 2 (TYK2) inhibitor NDI-034858. NDI-034858 is an oral, selective allosteric TYK2 inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis.

Takeda to Acquire Nimbus Therapeutics' Highly Selective, Allosteric TYK2 Inhibitor to Address Multiple Immune-Mediated Diseases

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that it will acquire NDI-034858 from Nimbus Therapeutics. NDI-034858 is an oral, selective allosteric tyrosine kinase 2 (TYK2) inhibitor being evaluated for the treatment of multiple autoimmune diseases following successful recent Phase 2b results in psoriasis. When the transaction is complete, NDI-034858 will be known as TAK-279.

Takeda to Acquire Late-Stage, Potential Best-in-Class, Oral Allosteric TYK2 Inhibitor NDI-034858 From Nimbus Therapeutics

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )-- Takeda ( TSE:4502/NYSE:TAK ) today announced that it will present 15 company-sponsored abstracts at the 64th American Society of Hematology (ASH) Annual Meeting being held December 10-13, 2022 in New Orleans. Takeda's latest research focuses on improving long-term outcomes for patients with hematologic diseases.

Takeda to Present Data at 64th American Society of Hematology (ASH) Annual Meeting, Demonstrating Commitment to Patients with Hematologic Cancers and Other Blood Diseases

OSAKA, Japan & CAMBRIDGE, Mass.--( BUSINESS WIRE )--Takeda ( TSE:4502/NYSE:TAK ) today announced that the European Commission (EC) granted marketing authorization for the company's dengue vaccine QDENGA® (Dengue Tetravalent Vaccine [Live, Attenuated]) (TAK-003) for the prevention of dengue disease in individuals from four years of age in the European Union (EU).i QDENGA should be used in accordance with official recommendations. The approval follows the positive recommendation from the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) in October 2022.

Takeda's QDENGA®▼ (Dengue Tetravalent Vaccine [Live, Attenuated]) Approved for Use in European Union

Strong top-line growth exhibited in FY22. Building regulatory and clinical momentum around its core offerings, with the bulk of the portfolio up double digits this year.

Takeda: Momentum Building Around Core Offerings, Rate Buy

OSAKA, Japan and CAMBRIDGE, Massachusetts--( BUSINESS WIRE )-- Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted and granted priority review of the Biologics License Application (BLA) for TAK-003, the company's investigational dengue vaccine candidate. In the U.S., TAK-003 is being evaluated for the prevention of dengue disease caused by any dengue virus serotype in individuals 4 years through 60 years of age.

Takeda's Biologics License Application (BLA) for Dengue Vaccine Candidate (TAK-003) Granted Priority Review by U.S. Food and Drug Administration

OSAKA, Japan & CAMBRIDGE, Mass--( BUSINESS WIRE )--Takeda (TSE:4502/NYSE:TAK) today announced that the randomized, Phase 3 PhALLCON trial met its primary endpoint, demonstrating that adult patients with newly-diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph+ ALL) treated with ICLUSIG® (ponatinib) plus reduced-intensity chemotherapy achieved higher rates of minimal residual disease (MRD)-negative complete remission (CR) compared to imatinib. MRD-negativity is associated with improvement in long-term outcomes for patients, as reported in literature. ICLUSIG is the only pan-mutational and third-generation tyrosine kinase inhibitor (TKI), targeting BCR::ABL1 and all known single, treatment-resistant mutations, including the most resistant T315I mutation.

Phase 3 Trial of ICLUSIG® (ponatinib) Met Primary Endpoint in Newly-Diagnosed Ph+ ALL, a Setting with No Targeted Treatments Approved in the US

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