Welcome to our dedicated page for Takeda Pharm news (Ticker: TAK), a resource for investors and traders seeking the latest updates and insights on Takeda Pharm stock.
The TAK news page on Stock Titan aggregates company-specific coverage for Takeda Pharmaceutical Company Limited American Depositary Shares (NYSE: TAK). Takeda’s own disclosures describe it as a values-based, R&D-driven biopharmaceutical company headquartered in Japan, with core therapeutic and business areas in gastrointestinal and inflammation, rare diseases, plasma-derived therapies, oncology, neuroscience and vaccines. Because of this broad focus and active pipeline, Takeda generates frequent news across clinical, regulatory, partnership and financial topics.
Recent press releases highlight late-stage clinical data and regulatory plans for several key programs. In neuroscience, Takeda has presented Phase 3 results for oveporexton (TAK-861), an investigational oral orexin receptor 2 agonist for narcolepsy type 1, showing statistically significant improvements in excessive daytime sleepiness, cataplexy and quality-of-life measures versus placebo. In immunology and dermatology, the company has reported pivotal Phase 3 data for zasocitinib (TAK-279), an investigational highly selective oral TYK2 inhibitor in moderate-to-severe plaque psoriasis, with studies meeting all primary and ranked secondary endpoints.
Takeda news also covers hematology and rare disease developments. Together with Protagonist Therapeutics, the company has released Phase 3 VERIFY and long-term THRIVE data for rusfertide, an investigational hepcidin mimetic for polycythemia vera, demonstrating durable hematocrit control, reduced phlebotomy requirements and maintained patient-reported outcome improvements. In nephrology, Takeda has shared Phase 1b data for mezagitamab (TAK-079) in primary IgA nephropathy, showing stable kidney function and sustained reductions in proteinuria and Gd-IgA1 levels up to 18 months after the last dose.
In vaccines, Takeda has announced seven-year Phase 3 TIDES trial data for its dengue vaccine QDENGA (TAK-003), reinforcing sustained protection against virologically confirmed dengue and dengue-related hospitalizations and supporting a two-dose regimen. Corporate and pipeline news includes strategic oncology collaborations, such as the global partnership with Innovent Biologics for late-stage assets IBI363 and IBI343, and financial updates on revenue trends, generic erosion impacts and revised full-year forecasts.
Investors and followers of TAK can use this news feed to track Takeda’s clinical milestones, regulatory filings, strategic alliances, portfolio prioritization decisions and IFRS-based financial disclosures as they are reported in press releases and SEC Form 6-K submissions.
Takeda Pharmaceutical Company Limited has announced its acquisition of Adaptate Biotherapeutics, enhancing its immuno-oncology portfolio. This acquisition follows a successful partnership and marks Takeda's third oncology 'build-to-buy' initiative in under a year. The deal focuses on Adaptate's antibody-based γδ T-cell engager platform aimed at cancer therapies, complementing previous acquisitions. This strategic move positions Takeda at the forefront of γδ T cell research, expected to finalize in Q1 of Takeda's fiscal year 2022, pending regulatory reviews.
Takeda Pharmaceutical Company Limited (NYSE: TAK) has received a Complete Response Letter (CRL) from the U.S. FDA regarding its New Drug Application for TAK-721 (budesonide oral suspension) aimed at treating eosinophilic esophagitis (EoE). The FDA indicated that the application could not be approved in its current state and recommended further clinical studies. Takeda expressed disappointment, noting that patients will continue to lack an FDA-approved treatment option.
Takeda Pharmaceutical Company Limited announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended approval of vedolizumab for the treatment of adults with moderately to severely active chronic pouchitis. If approved, vedolizumab would be the first authorized treatment for this condition in Europe, which affects patients post-surgery for ulcerative colitis. The positive opinion was based on findings from the EARNEST trial, showing significant clinical remission rates.
Takeda Pharmaceutical Company presented nine abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting held from December 11-14, 2021. The presentations highlight their commitment to innovative treatments in hematology, including data on ADYNOVATE for severe hemophilia A and an analysis of joint health biomarkers. Notably, the design of a phase 3b study of TAK-755, a first-of-its-kind replacement therapy, was shared. This emphasizes Takeda's ongoing advancements in therapies for rare blood disorders.
Takeda Pharmaceutical Company released results from the pivotal Phase 3 SOLSTICE trial, showing that LIVTENCITY (maribavir) significantly outperformed conventional therapies in treating post-transplant CMV infections. The primary endpoint was met with 55.7% of patients on LIVTENCITY achieving CMV DNA levels below 137 IU/mL compared to 23.9% for conventional therapies. Additionally, the key secondary endpoint of symptom control was also significantly better for LIVTENCITY. Adverse events were similar between groups, but fewer LIVTENCITY patients discontinued due to adverse events.
Takeda Pharmaceutical Company (TSE:4502/NYSE:TAK) announced it will present 23 company-sponsored abstracts at the 63rd American Society of Hematology (ASH) Annual Meeting from December 11-14, 2021 in Atlanta, Georgia. The presentations focus on advancing treatments in oncology and hematology, featuring pipeline candidates like Modakafusp Alfa (TAK-573) and Subasumstat (TAK-981). A key highlight includes updates on TAK-755, a novel therapy for Sickle Cell Disease and Congenital Thrombotic Thrombocytopenic Purpura.
Takeda Pharmaceutical Company announced the U.S. launch of LIVTENCITY™ (maribavir), the first treatment for post-transplant cytomegalovirus (CMV) infection/disease resistant to conventional antivirals. Available since December 2, 2021, after receiving FDA approval on November 23, LIVTENCITY is designed for patients aged 12 and over weighing at least 35 kg. With an estimated incidence rate of 16%-70% in transplant recipients, CMV poses serious health risks, emphasizing the need for effective treatments. LIVTENCITY offers a new option for clinicians in managing this complex infection.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a $20 million commitment to enhance its Corporate Social Responsibility (CSR) program in the U.S. during its first year. The program focuses on health equity, climate resiliency, K-8 math literacy, and food security, partnering with 20 grant recipients who will share $16.6 million in total grants. The initiative aims to alleviate social disparities and improve overall community well-being across various sectors.
Takeda Pharmaceutical Company Limited announced FDA approval for LIVTENCITY™ (maribavir), the first treatment for adults and pediatric patients (12 years and older) with post-transplant cytomegalovirus (CMV) infection refractory to conventional therapies. In the Phase 3 SOLSTICE study, 56% of patients on LIVTENCITY achieved CMV DNA levels
Takeda Pharmaceutical Company Limited (NYSE: TAK) has announced new policy recommendations aimed at improving care for patients with rare diseases. This initiative includes three primary reforms focused on enhancing access to genetic screenings and specialized care, as well as improving data standardization. A recent Morning Consult survey revealed that two-thirds of voters lack understanding of rare diseases, emphasizing the need for greater awareness. Takeda's report aims to address significant barriers to timely diagnoses and treatment, which currently average six years from symptom onset.