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Takeda's TAK-921 meets dual endpoints in gastric cancer trial

Fri, 23 Oct 2026 07:30:24 -0400

Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) announced that its experimental drug arcotatug tavatecan (TAK-921) met dual primary endpoints of overall survival (OS) and progression-free survival (PFS) in a Phase 3 study of patients with previously treated, CLDN18.2-positive advanced gastric or gastroesophageal junction adenocarcinoma.

Results from the G-HOPE-001 study (NCT06238843) were presented at the 2026 European Society for Medical Oncology Congress. The trial enrolled 464 participants across Japan and China, randomized to receive arcotatug tavatecan or treatment of physician's choice (TPC), which included irinotecan, paclitaxel, or trifluridine/tipiracil.

In the second interim analysis, with a data cutoff of September 3, 2026, median OS

Takeda Announces Arcotatug Tavatecan (TAK-921) Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase 3 Advanced Gastr

Fri, 23 Oct 2026 07:30:00 -0400

Data from the Registrational Phase 3 G-HOPE-001 Study of Arcotatug Tavatecan, a Novel, Potential Best-in-Class Claudin (CLDN)18.2 ADC, were Highlighted in a Late-Breaking Presentation at ESMO 2026
Arcotatug Tavatecan Met Dual Primary Endpoints of Overall Survival and Progression-Free Survival, Showing Significant Improvements vs. Treatment of Physician’s Choice in Patients with Previously Treated CLDN18.2-Positive Advanced Gastric Cancer
Findings to Support Planned Regulatory Filing in Japan and Continued Global Development of Arcotatug Tavatecan in CLDN18.2-Positive Cancers

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced positive results from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan

Takeda Announces Arcotatug Tavatecan (TAK-921) Demonstrated Statistically Significant and Clinically Meaningful Improvements in Overall Survival and Progression-Free Survival in Phase 3 Advanced Gastr

Fri, 23 Oct 2026 07:30:00 -0400

Data from the Registrational Phase 3 G-HOPE-001 Study of Arcotatug Tavatecan, a Novel, Potential Best-in-Class Claudin (CLDN)18.2 ADC, were Highlighted in a Late-Breaking Presentation at ESMO 2026
Arcotatug Tavatecan Met Dual Primary Endpoints of Overall Survival and Progression-Free Survival, Showing Significant Improvements vs. Treatment of Physician’s Choice in Patients with Previously Treated CLDN18.2-Positive Advanced Gastric Cancer
Findings to Support Planned Regulatory Filing in Japan and Continued Global Development of Arcotatug Tavatecan in CLDN18.2-Positive Cancers

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced positive results from the Phase 3 G-HOPE-001 study (NCT06238843) of arcotatug tavatecan

Takeda Entyvio trial shows disease clearance cuts UC complication risk

Mon, 19 Oct 2026 06:01:33 -0400

Takeda Pharmaceutical (NYSE: TAK) announced results from the VERDICT trial (NCT04259138), a Phase 4 study of ENTYVIO (vedolizumab), showing that treating adults with moderate to severe ulcerative colitis to a corticosteroid-free disease clearance target significantly reduced the risk of UC-related complications compared with treating to symptomatic remission alone.

The trial found that patients in the disease clearance group experienced a longer time to first UC-related complication, with a hazard ratio of 0.33 (95% confidence interval 0.17–0.67; P=0.0014), representing a roughly 70% reduction in complication risk over up to 80 weeks after target achievement. The findings were presented at UEG Week 2026

First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication

Mon, 19 Oct 2026 05:30:00 -0400

More than half of ENTYVIO patients who met their assigned treatment target reached disease clearance (composite of corticosteroid-free symptomatic, endoscopic and histologic remission) at Week 16
VERDICT is the first trial to provide macroscopic and microscopic evidence of intestinal tissue repair associated with disease clearance in largely bio-naïve patients treated with an advanced therapy

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced new data from VERDICT (NCT04259138), showing that treating adults with intravenous ENTYVIO® (vedolizumab) to achieve corticosteroid-free (CSF) disease clearance versus CSF symptomatic remission alone, resulted in a

First and Only Ulcerative Colitis Treat-to-Target Trial Shows Treating to Disease Clearance vs. Symptomatic Remission with ENTYVIO® (vedolizumab) Prolongs Time to First Disease-Related Complication

Mon, 19 Oct 2026 05:30:00 -0400

More than half of ENTYVIO patients who met their assigned treatment target reached disease clearance (composite of corticosteroid-free symptomatic, endoscopic and histologic remission) at Week 16
VERDICT is the first trial to provide macroscopic and microscopic evidence of intestinal tissue repair associated with disease clearance in largely bio-naïve patients treated with an advanced therapy

Takeda launches narcolepsy drug Orzeyful in Japan and China

Thu, 15 Oct 2026 05:58:39 -0400

Takeda Pharmaceutical (NYSE: TAK) announced the simultaneous launch of Orzeyful (oveporexton) in Japan and China for the treatment of narcolepsy type 1 (NT1), making the drug available to clinicians in both markets.

Orzeyful is an oral orexin receptor 2 (OX2R) agonist designed to address the underlying orexin deficiency associated with NT1. The drug received approval from China's National Medical Products Administration and Japan's Ministry of Health, Labour and Welfare within a month of each other, and was also approved by the U.S. Food and Drug Administration. In China, the drug is approved for adolescents aged 16 and older and adults, while

Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1

Wed, 14 Oct 2026 20:30:00 -0400

− ORZEYFUL is now available in Japan and China following approvals within a month of each other by China’s National Medical Products Administration (NMPA), the U.S. Food and Drug Administration (FDA) and Japan’s Ministry of Health, Labour and Welfare (MHLW)

− Discovered by Takeda scientists in Japan, ORZEYFUL is the lead medicine in Takeda’s orexin franchise, with multiple programs for sleep-wake disorders and conditions where orexin biology plays a role

− ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwide

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (

Takeda’s ORZEYFUL (oveporexton) Launches Simultaneously in Japan and China Giving Physicians First Access to Prescribe Novel Orexin Agonist to Patients with Narcolepsy Type 1

Wed, 14 Oct 2026 20:30:00 -0400

− ORZEYFUL set to launch next month in the U.S., following completion of DEA scheduling; Health Authority submissions underway worldwide

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (

Takeda's TAK-881 meets primary endpoint in Phase 2/3 PID trial

Wed, 14 Oct 2026 08:00:36 -0400

Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) announced results from its pivotal Phase 2/3 IgGNITE clinical trial evaluating investigational TAK-881, a subcutaneous immunoglobulin therapy candidate for Primary Immunodeficiency Disease (PID), at the 22nd Biennial Meeting of the European Society for Immunodeficiencies in Maastricht, the Netherlands.

The trial met its primary endpoint, demonstrating pharmacokinetic comparability between TAK-881 and Takeda's approved therapy HYQVIA in patients aged 16 years and older. TAK-881 delivers the same immunoglobulin dose in 50% less volume, with median infusion times shortened by 56.2 minutes, or 42.6%, when using one infusion site compared to HYQVIA, while maintaining up to once-monthly

Takeda Presents Phase 2/3 IgGNITE Study Results of Investigational Subcutaneous TAK-881 in Primary Immunodeficiency Disease (PID) at ESID 2026

Wed, 14 Oct 2026 08:00:00 -0400

− TAK-881 met its primary endpoint, demonstrating pharmacokinetic comparability to HYQVIA® in patients 16 years and older

− TAK-881 may shorten infusion times and offer the opportunity for fewer required infusion sites compared to HYQVIA with 50% less volume while maintaining up to once-monthly dosing

− Adult infection outcomes and safety and tolerability profiles were comparable to HYQVIA based on descriptive analyses and consistent with established IG therapy standards

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced detailed results from the pivotal Phase 2/3 IgGNITE clinical trial (TAK-881-3001) evaluating investigational TAK-881 [Immune Globulin Subcutaneous (Human),

Takeda Presents Phase 2/3 IgGNITE Study Results of Investigational Subcutaneous TAK-881 in Primary Immunodeficiency Disease (PID) at ESID 2026

Wed, 14 Oct 2026 08:00:00 -0400

− TAK-881 met its primary endpoint, demonstrating pharmacokinetic comparability to HYQVIA® in patients 16 years and older

− TAK-881 may shorten infusion times and offer the opportunity for fewer required infusion sites compared to HYQVIA with 50% less volume while maintaining up to once-monthly dosing

− Adult infection outcomes and safety and tolerability profiles were comparable to HYQVIA based on descriptive analyses and consistent with established IG therapy standards

Takeda psoriasis drug outperforms deucravacitinib in phase 3 trial

Wed, 30 Sep 2026 01:02:02 -0400

Takeda Pharmaceutical (TSE: 4502, NYSE: TAK) announced Phase 3 clinical trial results showing its investigational drug zasocitinib outperformed deucravacitinib in treating moderate-to-severe plaque psoriasis, according to data presented at the European Academy of Dermatology and Venereology Congress 2026 in Vienna.

In the head-to-head LATITUDE Atlas study, 36.5% of patients treated with zasocitinib achieved complete skin clearance, measured by a PASI 100 score, at week 16, compared with 13.9% of patients receiving deucravacitinib. The study enrolled 606 participants, with each group receiving either zasocitinib 30 mg or deucravacitinib 6 mg once daily. Zasocitinib also showed statistically superior results across all key secondary

Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill

Wed, 30 Sep 2026 01:00:00 -0400

Head-to-head LATITUDE Atlas data showed zasocitinib demonstrated statistical superiority to deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8
More than 2.5 times as many patients treated with zasocitinib achieved complete skin clearance (PASI 100) at week 16 compared to deucravacitinib
Additional analyses from the pivotal LATITUDE PsO 3001 and 3002 studies showed durable skin clearance and rapid and continued improvements in patient-reported itch and quality of life

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced new data from three Phase 3 LATITUDE psoriasis

Zasocitinib Delivered Superior Efficacy Versus Deucravacitinib in New Phase 3 Head-to-Head Results, Reinforcing Potential to Deliver Rapid and Durable Skin Clearance in a Convenient Once-Daily Pill

Wed, 30 Sep 2026 01:00:00 -0400

Head-to-head LATITUDE Atlas data showed zasocitinib demonstrated statistical superiority to deucravacitinib across the primary and all key secondary efficacy endpoints with higher rates of complete skin clearance observed as early as week 8
More than 2.5 times as many patients treated with zasocitinib achieved complete skin clearance (PASI 100) at week 16 compared to deucravacitinib
Additional analyses from the pivotal LATITUDE PsO 3001 and 3002 studies showed durable skin clearance and rapid and continued improvements in patient-reported itch and quality of life

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced new data from three Phase 3 LATITUDE psoriasis

Takeda to present phase 3 cancer drug data at ESMO 2026

Tue, 22 Sep 2026 09:30:22 -0400

Takeda Pharmaceutical (TSE: 4502 / NYSE: TAK) will present new oncology pipeline data at the European Society for Medical Oncology (ESMO) Congress in Madrid, Spain, October 23-27, 2026, according to a company statement.

A late-breaking abstract will feature results from the Phase 3 G-HOPE-001 study of arcotatug tavatecan (TAK-921), an investigational Claudin 18.2-targeted antibody-drug conjugate, in patients with previously treated advanced gastric or gastroesophageal junction adenocarcinoma. The study was conducted in Japan and China. Takeda said that pending evaluation of final results, the data could support a potential regulatory filing in Japan.

Two additional presentations will cover TAK-928, a PD-1/alpha-biased IL-2 bispecific

Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026

Tue, 22 Sep 2026 09:30:00 -0400

Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational Study of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer
TAK-928 Presentations Reinforce Potential in Patients with Immunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously Untreated NSCLC
Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and TAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11 Study Evaluating TAK-928 vs. Docetaxel Monotherapy

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced that new data from its oncology pipeline and portfolio will be presented at the European Society for

Takeda Highlights Late-Stage Oncology Pipeline Progress and Solid Tumor Portfolio Research, Led by Late-Breaking Phase 3 Arcotatug Tavatecan (TAK-921) Data, at ESMO 2026

Tue, 22 Sep 2026 09:30:00 -0400

Late-Breaking Abstract to Feature New Data from First Phase 3 Registrational Study of Arcotatug Tavatecan in Previously Treated Advanced Gastric Cancer
TAK-928 Presentations Reinforce Potential in Patients with Immunotherapy-Resistant Non-Small Cell Lung Cancer (NSCLC) and Previously Untreated NSCLC
Takeda Continues to Progress Clinical Development of Arcotatug Tavatecan and TAK-928; New Non-Squamous NSCLC Sub-Trial Added to Global Phase 3 MarsLight-11 Study Evaluating TAK-928 vs. Docetaxel Monotherapy

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE:TAK) announced that new data from its oncology pipeline and portfolio will be presented at the European Society for

Takeda Pharmaceutical (4502:JP) (TAK) PT Raised to JPY7,000 at Nomura/Instinet

Fri, 18 Sep 2026 08:56:51 -0400

Nomura/Instinet analyst Hiroyuki Matsubara raised the price target on Takeda Pharmaceutical (4502:JP) (NYSE: TAK) to JPY7,000.00 (from JPY6,700.00) while maintaining a Buy rating.

Takeda Pharmaceutical (4502:JP) (TAK) PT Raised to JPY7,000 at Nomura/Instinet

Fri, 18 Sep 2026 08:56:51 -0400

Nomura/Instinet analyst Hiroyuki Matsubara raised the price target on Takeda Pharmaceutical (4502:JP) (NYSE: TAK) to JPY7,000.00 (from JPY6,700.00) while maintaining a Buy rating.

Takeda Pharmaceutical (4502:JP) (TAK) PT Raised to JPY7,000 at Nomura/Instinet

Fri, 18 Sep 2026 08:56:51 -0400

Nomura/Instinet analyst Hiroyuki Matsubara raised the price target on Takeda Pharmaceutical (4502:JP) (NYSE: TAK) to JPY7,000.00 (from JPY6,700.00) while maintaining a Buy rating.

Takeda Pharmaceutical (4502:JP) (TAK) PT Raised to JPY7,000 at Nomura/Instinet

Fri, 18 Sep 2026 08:56:51 -0400

Nomura/Instinet analyst Hiroyuki Matsubara raised the price target on Takeda Pharmaceutical (4502:JP) (NYSE: TAK) to JPY7,000.00 (from JPY6,700.00) while maintaining a Buy rating.

Takeda Employees Select Four New Global Corporate Social Responsibility Collaborations to Advance Climate-Resilient Health Systems

Fri, 18 Sep 2026 01:00:00 -0400

2026 Awardees are Corus International, Humanity & Inclusion Handicap International, Kwame Nkrumah University of Science and Technology (KNUST) and Terre des hommes Foundation (Tdh)
Commitment of USD 22.2 Million Increases Takeda’s Total Global CSR Program Contributions to USD 260.9 Million Across 42 Diverse Collaborations Worldwide, With 20 Currently Ongoing in 42 Countries

OSAKA, Japan & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Takeda (TSE:4502/NYSE: TAK) announced that it has awarded a total of USD 22.2 million to four new Global Corporate Social Responsibility (CSR) partners as part of the company’s ongoing commitment to supporting climate-resilient health systems in low- and middle-income countries

Takeda Employees Select Four New Global Corporate Social Responsibility Collaborations to Advance Climate-Resilient Health Systems

Fri, 18 Sep 2026 01:00:00 -0400

2026 Awardees are Corus International, Humanity & Inclusion Handicap International, Kwame Nkrumah University of Science and Technology (KNUST) and Terre des hommes Foundation (Tdh)
Commitment of USD 22.2 Million Increases Takeda’s Total Global CSR Program Contributions to USD 260.9 Million Across 42 Diverse Collaborations Worldwide, With 20 Currently Ongoing in 42 Countries

Form 4 TAKEDA PHARMACEUTICAL For: Sep 14 Filed by: Duprey Lauren Rusckowski

Tue, 15 Sep 2026 21:13:00 -0400

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