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 announced the FDA's approval of EXKIVITY (mobocertinib) for treating adults with locally advanced or metastatic non-small cell lung cancer (NSCLC) with EGFR exon 20 insertion mutations. The approval is based on Phase 1/2 trial results showcasing a median duration of response of approximately 1.5 years. Additionally, a companion diagnostic test was approved to identify eligible patients. This marks Takeda's commitment to addressing the needs of underserved cancer patients, with ongoing efforts to expand treatment options.
Takeda Pharmaceutical Company Limited (NYSE:TAK) announced that its Phase 3 PANTHER study evaluating pevonedistat in combination with azacitidine for higher-risk myelodysplastic syndromes (MDS), chronic myelomonocytic leukemia (CMML), and low-blast acute myeloid leukemia (AML) did not reach statistical significance for the primary endpoint of event-free survival (EFS). Despite the disappointing outcome, Takeda aims to analyze the full data set to inform future research. The safety profile was consistent with previous reports, and full results will be presented at a medical congress.
BioLife Plasma Services, part of Takeda Pharmaceutical Company, has opened an all-electric plasma donation center in Tukwila, WA. This center initiates a sustainability initiative to address the rising demand for plasma while also tackling environmental challenges. The Tukwila center is part of BioLife's expanding network of over 150 facilities, recognized for high safety standards. Takeda aims for zero carbon emissions by 2040, emphasizing renewable technology and waste reduction. The center opens on August 21, inviting donors who will be compensated for their contributions.
Takeda Pharmaceutical Company (TSE: 4502/NYSE: TAK) announced the publication of the final results from the Phase 3 HELP Study Open-label Extension (OLE) evaluating TAKHZYRO (lanadelumab) in patients with hereditary angioedema (HAE). The study demonstrated an 87.4% reduction in overall HAE attack rate and a 93.4% decrease in attacks requiring acute treatment. Most patients reported an attack-free period of over 12 months. The safety profile was consistent with previous studies, with 54.7% of patients experiencing treatment-related adverse events, primarily injection site reactions.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a decision from the Irish Tax Appeals Commission on July 30, 2021, upholding a tax assessment related to a break fee from AbbVie Inc. received by Shire plc, which Takeda acquired in January 2019. The assessment amounted to 398 million EUR. Takeda plans to appeal this decision and will record a provision estimated at approximately 63 billion JPY in its financial statements for Q1 FY2021. This provision will not affect Takeda's Core or Underlying financial results for the fiscal year ending March 31, 2022.
Takeda Pharmaceutical Company Limited (NYSE:TAK) reported solid financial results for Q1 FY2021, ending June 30, 2021. Revenue increased by 18.4% to 949.6 billion yen ($8.6B), driven by a strong performance from its 14 global brands. Operating profit rose 48.6% to 248.6 billion yen ($2.2B), while net profit surged by 142.8% to 200.4 billion yen ($1.8B). Takeda remains on track to meet its full-year guidance, anticipating five to six regulatory submissions by year-end, fostering optimism for the growth of its innovative pipeline.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced a collaboration with Frazier Healthcare Partners to launch HilleVax, Inc. for developing and commercializing its norovirus vaccine candidate, HIL-214. Takeda has licensed exclusive rights for HIL-214's development outside Japan while retaining rights in Japan. The vaccine candidate has shown efficacy in preventing moderate-to-severe norovirus cases and has been studied in nine clinical trials. This partnership allows Takeda to focus on other vaccines, including those for dengue and COVID-19.
Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) announced that the FDA granted Breakthrough Therapy Designation to TAK-994, an oral orexin agonist in Phase 2 trials for treating excessive daytime sleepiness (EDS) in narcolepsy type 1 patients. This designation aims to expedite development for serious conditions and indicates promising preliminary clinical data suggesting improved wakefulness metrics. TAK-994 represents a significant step in addressing orexin deficiency in NT1 and is part of Takeda's innovative neuroscience research.
Takeda has announced the results of a phase 3 trial for recombinant von Willebrand factor (rVWF) prophylaxis, presented at the ISTH Virtual Congress 2021. The study involved 23 patients with severe von Willebrand disease (VWD) over 12 months. Results indicated a 91.5% reduction in spontaneous, treated annualized bleeding rates (sABRs) compared to historical data from prior on-demand treatments. No new safety risks were identified, bolstering Takeda's commitment to improving patient outcomes in rare bleeding disorders.
Takeda Pharmaceutical Company Limited (TOKYO:4502) (NYSE:TAK) has filed its Corporate Governance Report with the Tokyo Stock Exchange, as required for TSE listed companies. This report is based on the Corporate Governance Code effective since June 1, 2018, with a revised version due by December 2021. The report can be accessed on Takeda’s website. An English version has also been submitted to the U.S. Securities and Exchange Commission. For more information about Takeda's corporate governance policies and ESG initiatives, refer to their 2021 Annual Integrated Report.