Takeda News and Stock Quote (NYSE: TAK)

September 20, 2023

Takeda Announces FDA Acceptance of NDA Resubmission of TAK-721 (budesonide oral suspension) for the Short-Term Treatment of Eosinophilic Esophagitis (EoE)

OSAKA, Japan & CAMBRIDGE, Mass. / Sep 20, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its New Drug Application (NDA) resubmission for TAK-721 (budesonide oral suspension) which is being investigated for the short-term treatment of eosinophilic esophagitis (EoE), a chronic inflammatory disease that can cause damage to the... Read More

September 13, 2023

Takeda Commits Over $30 Million in Five New Global CSR Partnerships To Further Drive Health Impact in 92 Countries

Takeda’s Five New Partnerships Boost Total Global CSR Program Contributions to JPY 24.2 Billion (Approx. USD 167.5 million) Since Program Inception in 2016. More Than 24,500 Takeda Employees Worldwide Participated in the Selection of the Five New Partnerships: Society for Family Health Rwanda, Relief International, Mercy Corps, University of Nairobi and Partners In Health. With This New Cohort of Partnerships, Takeda’s... Read More

September 13, 2023

Takeda Announces FDA Acceptance of BLA for Subcutaneous Administration of ENTYVIO® (vedolizumab) for Maintenance Therapy in Moderately to Severely Active Crohn’s Disease

Applications for Investigational Subcutaneous Administrations for Both Crohn’s Disease and Ulcerative Colitis Are Now Under Review by the FDA OSAKA, Japan & CAMBRIDGE, Mass. / Sep 13, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review its Biologics License Application (BLA) for the investigational subcutaneous (SC) administration of... Read More

September 12, 2023

Patient-led Innovations in Inflammatory Bowel Disease Take the Prize in Takeda Canada's Digital Health Challenge

The 2023 Winners are Ayble Health and IBDrelief TORONTO , Sept. 12, 2023 /CNW/ - Takeda Canada Inc. ("Takeda") is pleased to announce two winners of the 2023 Takeda Canada Digital Health Innovation Challenge , a competition to identify and support innovative digital health solutions to improve patient outcomes and experiences. This year's challenge winners are two patient-led organizations with disruptive digital solutions... Read More

September 11, 2023

Takeda Announces Positive Topline Results from Phase 2b Study Evaluating TAK-279, a Highly Selective Oral TYK2 Inhibitor, for the Treatment of Active Psoriatic Arthritis

Topline Results for TAK-279 Show that a Significantly Greater Proportion of Psoriatic Arthritis Patients Achieved at Least an ACR20 Response Compared to Placebo at Week 12 1 Based on the Positive Results, Takeda Intends to Initiate a Phase 3 Study of TAK-279 in Psoriatic Arthritis Full Clinical Results Will be Presented at an Upcoming Medical Meeting OSAKA, Japan & CAMBRIDGE, Mass. / Sep 11, 2023 / Business Wire / Takeda... Read More

July 27, 2023

Takeda Reports Strong First Quarter FY2023 Results, Driven by Growth & Launch Products

No Change to Full-Year Forecasts or Management Guidance Revenue Growth of +8.9% at Actual Exchange Rate (AER); +3.7% Growth at Constant Exchange Rate (CER), Driven by Growth & Launch Products (+16.2% at CER) Reported Operating Profit Growth of +12.0% at AER; Core Operating Profit Decline of -2.0% at CER Reflecting Generic Impact, Lower Demand for Coronavirus Vaccines and Increased Investment in R&D and Data & Technology Core... Read More

July 26, 2023

Takeda: The New England Journal of Medicine Publishes Data from Phase 2 Study of First Oral Orexin Receptor 2 Agonist TAK-994 in Patients with Narcolepsy Type 1

Trial Was Stopped Due to Hepatotoxicity and Consequently TAK-994 Program Terminated for Further Development In Patients with Narcolepsy Type 1, Oral Orexin Receptor 2 Agonist Demonstrated Statistically Significant Improvement in Daytime Wakefulness; Weekly Cataplexy Rates Reduced or Abolished at All Doses Compared to Placebo Findings Indicate Orexin Receptor 2 as Promising Novel Biologic Target for Future Development of... Read More

June 25, 2023

Takeda: Pivotal Phase 3 Data Presented at ISTH 2023 Congress Spotlight TAK-755 Prophylaxis for Patients with Congenital Thrombotic Thrombocytopenic Purpura (cTTP)

Data from First and Only Phase 3 Controlled Trial in cTTP Demonstrate Strong Efficacy and Favorable Safety Profile with TAK-755 (recombinant ADAMTS13), Compared to Plasma-Based Therapies Patients Receiving TAK-755 Achieved an Increase in Plasma ADAMTS13 Enzyme Activity Levels, Which Are Deficient in Patients with cTTP, Compared to Plasma-Based Therapies OSAKA, Japan & CAMBRIDGE, Mass. / Jun 25, 2023 / Business Wire / Takeda... Read More

June 20, 2023

Takeda Presents Full Data Set from Phase 3 ADVANCE-CIDP 1 Clinical Trial Investigating HYQVIA® as a Maintenance Therapy for Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) at PNS Annual Meeting

Pivotal Phase 3 Findings with HYQVIA [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] Showed a Clinically Significant Reduction in Relapse Rate as well as a Delayed Time to Relapse Compared to Placebo When Used as a Maintenance Therapy in Adult Patients with CIDP ADVANCE Clinical Program Reflects Takeda’s Commitment to Investigating Immunoglobin (IG) Therapy for Patients with Neuroimmunological... Read More

June 15, 2023

Takeda and HUTCHMED Announce Publication of Phase 3 FRESCO-2 Results in The Lancet

Publication shows FRESCO-2 demonstrated treatment with fruquintinib reduced the risk of death by 34% in previously treated metastatic colorectal cancer (0.66 HR) Data support regulatory submissions in the U.S., Europe and Japan during 2023 OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J. / Jun 15, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) and HUTCHMED (China) Limited (Nasdaq/AIM:HCM,... Read More

May 26, 2023

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

CAMBRIDGE, Mass. & OSAKA, Japan / May 26, 2023 / Business Wire / 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,... Read More

May 25, 2023

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

Prescription Drug User Fee Act (PDUFA) Target Action Date Set for November 30, 2023 NDA Includes Results From the Phase 3 FRESCO-2 and FRESCO Clinical Trials OSAKA, Japan & CAMBRIDGE, Mass. & HONG KONG & SHANGHAI & FLORHAM PARK, N.J. / May 25, 2023 / Business Wire / 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)... Read More

May 16, 2023

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

Submission Based on Favorable Results from the First Phase 3 Randomized, Controlled Trial in Patients with cTTP FDA has Granted TAK-755 Priority Review and Rare Pediatric Disease Designation, as well as Fast Track Designation and Orphan Drug Designation in cTTP OSAKA, Japan & CAMBRIDGE, Mass. / May 16, 2023 / Business Wire / Takeda (TSE: 4502/NYSE:TAK) today announced that the U.S. Food and Drug Administration (FDA) has... Read More

May 11, 2023

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

Full Year Reported Revenue Growth of +12.8%; Core Revenue Growth of +3.5% at Constant Exchange Rate Driven by Growth & Launch Products; Reported EPS Growth of +38.8% Achieved Core Operating Profit of 1,188.4 Billion Yen – Exceeding 1 Trillion Yen for the First Tim e in the Company’s History FY2023 Core Operating Profit Expected to Remain >1 Trillion Yen Despite Impact of Loss of Exclusivity and Lower Expectations for... Read More

May 10, 2023

Takeda Canada Presents Real-World Clinical Effectiveness and Safety Results of Vedolizumab (ENTYVIO®) and Ustekinumab as First-Line Biologic Treatment for Crohn's Disease

TORONTO , May 10, 2023 /CNW/ - Takeda Canada Inc. ("Takeda") announces results from the EVOLVE Expansion study, which evaluated the safety and efficacy of vedolizumab (ENTYVIO ®) , a gut-selective α4β7-integrin inhibitor and ustekinumab (UST), an IL-12/23 p40 inhibitor, as first-line biologic treatment for patients with Crohn's disease (CD). The data were presented as an oral presentation at Digestive Disease Week ® (DDW)... Read More

April 27, 2023

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. / Apr 27, 2023 / Business Wire / 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)... Read More

April 26, 2023

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 T akeda 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... Read More

April 20, 2023

Takeda has Secured Three-Year Contract in Key Immunoglobulin Category

Takeda continues its commitment to delivering innovative therapies that allow Canadians with primary and secondary immunodeficiency to live their lives to the fullest TORONTO , April 20, 2023 /CNW/ - Takeda Canada Inc. (Takeda) has entered into a three-year agreement with Canadian Blood Services (CBS) that includes GAMMAGARD LIQUID ® , GAMMAGARD ® S/D and CUVITRU ® , resulting from CBS's request for proposal for... Read More

April 11, 2023

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

HYQVIA ® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase], the Only Once-a-Month – Every Three or Four Weeks – Subcutaneous Immunoglobulin (ScIG), is Now Approved for People Two Years of Age and Older with Primary Immunodeficiency Approval Supported by Pivotal Phase 3 Study that Demonstrated Reliable Infection Protection in Children 2-16 Years Old CAMBRIDGE, Mass. / Apr 11, 2023 / Business Wire /... Read More

April 3, 2023

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

FY22 Investment Brings Program Total to Nearly $40 Million, Adding 21 New Grant Partners Company Continues to Improve Equity Among Under-Resourced Communities Focusing on Areas of Health, Education, Environment and Providing First U.S. CSR Report, Takeda Cares for Communities, Highlights Program Efforts Since its FY21 Launch CAMBRIDGE, Mass. / Apr 03, 2023 / Business Wire / Takeda ( TSE:4502/NYSE:TAK ) today announced that... Read More

March 30, 2023

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

The Phase 4 EARNEST Study Met Its Primary Efficacy Endpoint of Remission of Chronic or Recurrent Pouchitis at Week 14, with 31% of Participants Receiving Vedolizumab Achieving Remission versus 10% Receiving Placebo. 1 Superiority over Placebo Was Also Demonstrated at Week 34, with 35% of Vedolizumab Patients Achieving Remission Compared with 18% on Placebo. 1 OSAKA, Japan & CAMBRIDGE, Mass. / Mar 30, 2023 / Business Wire /... Read More

March 30, 2023

Takeda Announces Candidates for Board of Directors at Upcoming Shareholders Meeting

OSAKA, Japan / Mar 30, 2023 / Business Wire / 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 147 th Ordinary Meeting of Shareholders on June 28 th , 2023. The new candidate, Miki Tsusaka, will join the board effective June 28 th , if approved by the shareholders. Furthermore, Masato Iwasaki, Representative Director,... Read More

March 27, 2023

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

Expansion Contributes to the Company's Efforts Toward a Sustainable Global Plasma Supply to Support the Needs of People who Depend on Life-Saving Plasma Therapies. BANNOCKBURN, Ill. / Mar 27, 2023 / Business Wire / BioLife Plasma Services , part of the global biopharmaceutical company Takeda, today announced the opening of its 200 th plasma donation center in the United States (U.S.)., with new locations in West Springfield,... Read More

March 18, 2023

Takeda Pharmaceutical 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. / Mar 18, 2023 / Business Wire / 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... Read More

February 18, 2023

Takeda Pharmaceutical 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. / Feb 18, 2023 / 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... Read More

February 8, 2023

Takeda Pharmaceutical Completes Acquisition of Nimbus Therapeutics’ TYK2 Program Subsidiary

OSAKA, Japan & CAMBRIDGE, Mass. / Feb 08, 2023 / 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.... Read More

February 3, 2023

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. / Feb 03, 2023 / 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 <12 years of age. 1 Prior to today’s approval, the only... Read More

February 2, 2023

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

Announced Agreement With Nimbus Therapeutics in December to Acquire a Potential Best-in-Class TYK2 Inhibitor, and with HUTCHMED in January to In-license Highly Selective, Oral Tyrosine Kinase Inhibitor Continued Momentum With Q3 Year-to-Date Reported Revenue Growth of +13.9% and Core Revenue Growth of +4.5% at Constant Exchange Rate; Reported EPS Growth of +19.6% Approval for Dengue Vaccine, QDENGA ® in EU; U.S. FDA Priority... Read More

January 23, 2023

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

With Marketing Authorization Submissions in the U.S., European Union and Japan Planned in 2023, Fruquintinib Offers a Potential New Treatment Option for Patients with Refractory Metastatic Colorectal Cancer Licensing Agreement for Fruquintinib Strengthens Takeda’s Growing Oncology Portfolio OSAKA, Japan & CAMBRIDGE, Mass. / Jan 23, 2023 / Business Wire / Takeda (TSE:4502/NYSE:TAK) today announced that it has entered into an... Read More

January 17, 2023

Takeda Recognized as a Top Employer in Canada in 2023

TORONTO , Jan. 17, 2023 /CNW/ - The Top Employers Institute has named Takeda Canada Inc. ("Takeda") a top employer in Canada for 2023. The distinction is recognized by the Top Employers Institute that certifies organizations who are focused on putting their people first through their exceptional HR policies. The Top Employers Institute program certifies organizations based on the participation and results of their HR Best... Read More

January 16, 2023

Takeda Named Global Top Employer for Sixth Consecutive Year

Achieved Global Recognition and Top Employer Certification in 22 Countries from Top Employers Institute Global Recognition Reinforces Commitment to People and Outstanding People Policies 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... Read More

January 11, 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

EXKIVITY is the First Category-1 Innovative Drug Approved for Takeda China Following a Phase 2 Global Pivotal Study Approval Based on Data from the Phase 1/2 Clinical Trial Demonstrating EXKIVITY’s Clinical Benefit and Durable Responses in EGFR Exon20 Insertion+ NSCLC Results Demonstrated a Confirmed Overall Response Rate (ORR) of 28% and Median Duration of Response (DoR) of 15.8 Months per Independent Review Committee (IRC)... Read More

January 9, 2023

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

Fibrosis regression observed in 50% of patients receiving fazirsiran Median reductions of 94% of Z-AAT accumulation in the liver and mean reduction of 68% in histologic globule burden Treatment emergent adverse events were generally well balanced between fazirsiran and placebo groups Results consistent with AROAAT-2002 open-label study previously published in The New England Journal of Medicine Arrowhead to host webcast... Read More

January 5, 2023

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

Results are From First and Only Phase 3 Trial in cTTP, an Ultra-Rare Disease with Limited Treatment Options cTTP is Caused by a Deficiency in ADAMTS13 Protease; 1 TAK-755 Is Designed to Replace Missing or Deficient ADAMTS13 Enzyme 2 Takeda Plans to Seek Marketing Authorization for TAK-755 as the First ADAMTS13 Replacement Therapy for the Treatment of cTTP Takeda (TSE:4502/NYSE:TAK) today announced that the totality of... Read More

December 21, 2022

Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging

TOKYO and OSAKA, Japan , Dec. 21, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa , "Astellas"), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito , "Eisai"), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe , "Daiichi Sankyo") and Takeda Pharmaceutical Company Limited . (TSE: 4502 / NYSE:TAK, President and CEO Christophe Weber , "Takeda") today announced that the four... Read More

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