TAK - Takeda Pharmaceutical Company Limited

Takeda to Present Oncology Portfolio and Pipeline Data at the 2023 ASCO Annual Meeting and EHA Congress

CAMBRIDGE, Mass. & OSAKA, Japan, May 26, 2023--Takeda (TSE: 4502/NYSE:TAK) today announced that it will present data from its expanding oncology pipeline and established product portfolio at the 59th Annual Meeting of the American Society of Clinical Oncology (ASCO) being held June 2-6, 2023, in Chicago, Ill. and the 31st Congress of the European Hematology Association (EHA), June 8-11, 2023, in Frankfurt, Germany.

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  First Prospective Clinical Validation of Allarity's DRP® Companion Diagnostic to be Presented at 2023 ASCO Annual Meeting

  GlobeNewswire
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  Morphogenesis, Inc. and CohBar, Inc. Announce Acceptance of Abstract for Poster Presentation at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

  GlobeNewswire

Takeda and HUTCHMED Announce New Drug Application (NDA) for Fruquintinib for Treatment of Previously Treated Metastatic Colorectal Cancer Granted Priority Review

OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J., May 25, 2023--Takeda (TSE:4502/NYSE:TAK) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM, HKEX:13) (HUTCHMED) today announced that the U.S. Food and Drug Administration (FDA) has granted priority review of the New Drug Application (NDA) for fruquintinib, a highly selective and potent inhibitor of vascular endothelial growth factor receptors (VEGFR) -1, -2 and -3 for the treatment of adult patients with previously treated m

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  SpringWorks Therapeutics Announces Full Enrollment of Phase 2 Trial Evaluating Nirogacestat in Patients with Ovarian Granulosa Cell Tumors

  GlobeNewswire
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  AUM Biosciences Doses First Patient in Phase 2 Clinical Trial of AUM001 in Metastatic Colorectal Cancer

  GlobeNewswire

U.S. Food & Drug Administration Grants Priority Review of TAK-755 for the Treatment of Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

OSAKA, Japan & CAMBRIDGE, Mass., May 17, 2023--Takeda (TSE: 4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has accepted Takeda’s Biologics License Application (BLA) for TAK-755, an enzyme replacement therapy for the treatment of congenital thrombotic thrombocytopenic purpura (cTTP), an ADAMTS13 deficiency disorder. The TAK-755 application was accepted by the FDA on May 16th, and has been granted Priority Review.

Takeda Delivers Strong Revenue and Profit Growth in FY2022; Updated Capital Allocation Policy Reflects Deleveraging Progress and Confidence in Growth Outlook

OSAKA, Japan & CAMBRIDGE, Mass., May 11, 2023--Takeda (TOKYO:4502/NYSE:TAK) today announced strong financial results for fiscal year 2022 (period ended March 31, 2023), delivering or exceeding management guidance, driven by the performance of its Growth & Launch Products.

Takeda Announces FDA Acceptance of BLA Resubmission for Investigational Subcutaneous Administration of Entyvio® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Ulcerative Colitis

OSAKA, Japan & CAMBRIDGE, Mass., April 27, 2023--Takeda (TSE:4502/NYSE:TAK) ("Takeda") today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) resubmission for the investigational subcutaneous (SC) administration of Entyvio® (vedolizumab) for maintenance therapy in adults with moderately to severely active ulcerative colitis (UC) after induction therapy with Entyvio intravenous. The resubmission is intended to address FDA f

Corza Medical Signs Definitive Agreement to Acquire Takeda's TachoSil Manufacturing Operations

WESTWOOD, Mass., April 26, 2023 (GLOBE NEWSWIRE) -- Corza Medical announced today that it has entered into a definitive agreement with a subsidiary of Takeda Pharmaceuticals Company (TSE:4502/NYSE:TAK) (“Takeda”) to acquire the TachoSil manufacturing operations in Linz, Austria. Corza Medical had previously acquired the commercial product rights for TachoSil, a best-in-class surgical patch trusted by medical professionals worldwide, in January 2021. Corza Medical shares Takeda’s commitment to pa

HUTCHMED Announces NDA Acceptance in China for Fruquintinib in Second-Line Gastric Cancer

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J. , April 17, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:​HCM; HKEX:​13) today announces that its New Drug Application (“NDA”) for fruquintinib in combination with paclitaxel for the treatment of second-line advanced gastric or gastroesophageal junction adenocarcinoma in China has been accepted for review by the China National Medical Products Administration (“NMPA”). Dr. Michael Shi, Head of R&D and Chief Medical

Takeda Receives FDA Approval to Expand the Use of HYQVIA® to Treat Primary Immunodeficiency in Children

CAMBRIDGE, Mass., April 11, 2023--U.S. FDA approval of the expanded indication for the use of HYQVIA in the treatment of children 2-16 years old with primary immunodeficiency.

CENTOGENE Extends Strategic Partnership With Takeda to Continue Providing Access to Genetic Testing for Patients With Lysosomal Storage Disorders

The global market access and expansion partnership, initially established in 2015, aims to provide an efficient and timely diagnosis to patients with Lysosomal Storage Disorders (LSDs) Diagnosis plays a critical role in guiding patients towards appropriate and readily available therapies that can enhance their quality of life CAMBRIDGE, Mass. and ROSTOCK, Germany and BERLIN, April 11, 2023 (GLOBE NEWSWIRE) -- Centogene N.V. (Nasdaq: CNTG), the essential life science partner for data-driven answe

Takeda Announces New U.S. Corporate Social Responsibility (CSR) Program Partners

CAMBRIDGE, Mass., April 03, 2023--Takeda (TSE:4502/NYSE:TAK) today announced that 21 new U.S. non-profit organizations have received grants as part of the company’s $19.5 million commitment to its FY2022 Corporate Social Responsibility program. Combined with its initial investment of $20 million in FY2021, Takeda is delivering a collective amount of $39.5 million to help improve equity among under-resourced communities in the areas of health, education, the environment and providing access to he

HUTCHMED Completes Rolling Submission of NDA to U.S. FDA for Fruquintinib for the Treatment of Refractory Metastatic Colorectal Cancer

— NDA supported by data from global Phase III FRESCO-2 study in the U.S., Europe, Japan and Australia along with data from Phase III FRESCO study conducted in China — — FRESCO-2 showed fruquintinib treatment reduced the risk of death by 34% in refractory metastatic colorectal cancer (0.66 HR), consistent with the 35% reduction in the risk of death seen in FRESCO — — Marketing authorization submissions in Europe and Japan on track to complete in 2023 — HONG KONG and SHANGHAI, China and FLORHAM PA

Takeda Announces Results From Phase 4 Vedolizumab Study in Patients With Chronic Pouchitis Published in New England Journal of Medicine

OSAKA, Japan & CAMBRIDGE, Mass., March 30, 2023--Takeda (TSE:4502/NYSE:TAK) today confirmed that the New England Journal of Medicine (NEJM) has published positive data from the Phase 4 EARNEST study of vedolizumab for the treatment of chronic pouchitis. The NEJM article is titled "Vedolizumab for the Treatment of Chronic Pouchitis".

Takeda Announces Candidates for Board of Directors at Upcoming Shareholders Meeting

OSAKA, Japan, March 30, 2023--Takeda (TSE:4502/NYSE:TAK) announced that its Board of Directors today decided that it will propose a new candidate for independent external director at the 147th Ordinary Meeting of Shareholders on June 28th, 2023. The new candidate, Miki Tsusaka, will join the board effective June 28th, if approved by the shareholders. Furthermore, Masato Iwasaki, Representative Director, Japan General Affairs expressed his intention to retire on the same day. All other current bo

BioLife Plasma Services Opens its 200th Plasma Donation Center in the U.S.

BANNOCKBURN, Ill., March 27, 2023--BioLife Plasma Services, part of the global biopharmaceutical company Takeda, today announced the opening of its 200th plasma donation center in the United States (U.S.)., with new locations in West Springfield, Mass. and Pearland, Texas. This is an important milestone in BioLife’s broader expansion plans to continue opening centers in the U.S. to address the urgent and growing need for plasma.

Takeda Announces Positive Results in Phase 2b Study of Investigational TAK-279, an Oral, Once-Daily TYK2 Inhibitor, in People with Moderate-to-Severe Plaque Psoriasis

OSAKA, Japan & CAMBRIDGE, Mass., March 18, 2023--Takeda (TSE:4502/NYSE:TAK) today announced positive results from a Phase 2b clinical trial of TAK-279 (NDI-034858), a highly selective, oral allosteric tyrosine kinase 2 (TYK2) inhibitor, in patients with moderate-to-severe plaque psoriasis. The study met its primary and secondary endpoints, with a statistically significant greater proportion of TAK-279 patients achieving Psoriasis Area and Severity Index (PASI) 75, 90 and 100 in the 5mg, 15mg and

HUTCHMED Announces Closing of Fruquintinib License to Takeda Outside China

HONG KONG and SHANGHAI, China and FLORHAM PARK, N.J., March 14, 2023 (GLOBE NEWSWIRE) -- HUTCHMED (China) Limited (“HUTCHMED”) (Nasdaq/AIM:HCM, HKEX:13) today announces that, further to its announcement on January 23, 2023 and following the completion of customary closing conditions including antitrust regulatory reviews, the exclusive license agreement with a subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502, NYSE:TAK) to further the global development, commercialization and manufac

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)

OSAKA, Japan & CAMBRIDGE, Mass., February 18, 2023--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.1 Intestinal aGvHD is a serious complication characterized by inflammation

Takeda Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary

OSAKA, Japan & CAMBRIDGE, Mass., February 08, 2023--Takeda today announced that it has completed an acquisition of all shares of Nimbus Lakshmi, Inc. from Nimbus Therapeutics, LLC

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 & CAMBRIDGE, Mass., February 03, 2023--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 <12 years of age.1 Prior to today’s approval, the only approved routine prophylaxis treatment options for children 6 to <12 years of age requir

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

OSAKA, Japan, February 02, 2023--Takeda (TOKYO:4502/NYSE:TAK) today announced financial results for the third quarter of fiscal year 2022 (period ended December 31, 2022).

HUTCHMED Announces License to Takeda to Develop and Commercialize Fruquintinib Outside China

— HUTCHMED to receive US$400 million upfront on deal closing and up to US$730 million in potential future milestone payments, totaling up to US$1.13 billion, plus royalties on net sales — — Marketing authorization submissions in the U.S., Europe and Japan planned to complete in 2023 — — Partnership approach aligned with HUTCHMED’s path to profitability and strategy to bring its innovative medicines to patients worldwide — — HUTCHMED to host a conference call and webcast at 8:30 a.m. EST (1:30 p.

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., January 23, 2023--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 Named Global Top Employer for Sixth Consecutive Year

OSAKA, Japan & CAMBRIDGE, Mass., January 17, 2023--Takeda is one of only 15 companies to achieve global Top Employer® certification for 2023.

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

OSAKA, Japan & CAMBRIDGE, Mass., January 11, 2023--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

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. & PASADENA, Calif., January 09, 2023--Takeda and Arrowhead announce Phase 2 results of fazirsiran for the treatment of alpha-1 antitrypsin deficiency-associated liver disease.