Takeda Pharmaceutical Co Ltd 6-K Filing

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• form6k_121825.htm (6-K) — 58KB
• 0001395064-25-000174.txt ( ) — 59KB

SIGNATURES

SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized. TAKEDA PHARMACEUTICAL COMPANY LIMITED Date December 18, 2025 By s Norimasa Takeda Norimasa Takeda Chief Accounting Officer and Corporate Controller News Release Takeda's Zasocitinib Landmark Phase 3 Plaque Psoriasis Data Show Promise to Deliver Clear Skin in a Once-Daily Pill, Catalyzing a New Era of Treatment Pivotal Phase 3 studies of once-daily oral zasocitinib met all primary and ranked secondary endpoints in patients with moderate-to-severe plaque psoriasis More than half of study participants treated with zasocitinib achieved clear or almost clear skin (PASI 90), and on average about 30 percent achieved completely clear skin (PASI 100) by week 16 Zasocitinib was generally well-tolerated with a safety profile consistent with previous clinical studies ______________________________________________________________________________ OSAKA Japan AND CAMBRIDGE, Massachusetts, December 18, 2025 – Takeda (TSE4502NYSETAK) today announced positive topline results for the two pivotal Phase 3 randomized, multicenter, double-blind, placebo- and active comparator-controlled studies of zasocitinib (TAK-279), a next-generation, highly selective oral tyrosine kinase 2 (TYK2) inhibitor, in adults with moderate-to-severe plaque psoriasis (PsO). The studies demonstrated superiority of zasocitinib compared to placebo for the co-primary endpoints, static Physician Global Assessment (sPGA) 01 and Psoriasis Area and Severity Index (PASI) 75, at week 16, with a significantly greater PASI 75 response rate seen as early as week 4 and continuing to increase through week 24. The studies also met all 44 ranked secondary endpoints, including PASI 90, PASI 100 and sPGA 0 against placebo and apremilast, showing the potential of a convenient once-daily pill to deliver complete skin clea

Forward-Looking Statements

Forward-Looking Statements This press release and any materials distributed in connection with this press release may contain forward-looking statements, beliefs or opinions regarding Takeda's future business, future position and results of operations, including estimates, forecasts, targets and plans for Takeda. Without limitation, forward-looking statements often include words such as "targets", "plans", "believes", "hopes", "continues", "expects", "aims", "intends", "ensures", "will", "may", "should", "would", "could", "anticipates", "estimates", "projects", "forecasts", "outlook" or similar expressions or the negative thereof. These forward-looking statements are based on assumptions about many important factors, including the following, which could cause actual results to differ materially from those expressed or implied by the forward-looking statements the economic circumstances surrounding Takeda's global business, including general economic conditions in Japan and the United States and with respect to international trade relations competitive pressures and developments changes to applicable laws and regulations, including tax, tariff and other trade-related rules challenges inherent in new product development, including uncertainty of clinical success and decisions of regulatory authorities and the timing thereof uncertainty of commercial success for new and existing products manufacturing difficulties or delays fluctuations in interest and currency exchange rates claims or concerns regarding the safety or efficacy of marketed products or product candidates the impact of health crises, like the novel coronavirus pandemic the success of our environmental sustainability efforts, in enabling us to reduce our greenhouse gas emissions or meet our other environmental goals the extent to which our efforts to increase efficiency, productivity or cost-savings, such as the integration of digital technologies, including artificial intelligence, in our business or oth

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