Recent Updates — TAK
Takeda Pharmaceutical announced that the U.S. FDA accepted its New Drug Application for zasocitinib (TAK-279) under Priority Review for the treatment of moderate-to-severe plaque psoriasis. The submission is supported by pivotal Phase 3 LATITUDE PsO studies involving nearly 3,000 patients, which demonstrated rapid and durable skin clearance with approximately 70% of patients achieving clear or almost clear skin at week 16. The European Medicines Agency also accepted the marketing authorization application. The Prescription Drug User Fee Act target action date is in the first quarter of calendar year 2027. Takeda stated the filing has no significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027. Takeda is a global biopharmaceutical company focused on discovering and delivering treatments in areas such as oncology, neuroscience, vaccines, and rare diseases.
Takeda Pharmaceutical Company Limited received U.S. FDA approval for MIMRYLO (rusfertide), a first-in-class hepcidin mimetic indicated for the treatment of erythrocytosis in adults with polycythemia vera. The approval is supported by Phase 3 VERIFY study results, which demonstrated that 76.9% of patients achieved clinical response during weeks 20-32, maintaining hematocrit control and reducing phlebotomy burden. Takeda stated this approval does not change its consolidated financial forecast for the fiscal year ending March 31, 2027. The company operates in the pharmaceutical industry, focusing on discovering and delivering life-transforming treatments across various therapeutic areas including oncology and rare diseases.
Takeda Pharmaceutical Company Limited announced that the U.S. Food and Drug Administration (FDA) approved ORZEYFUL™ (oveporexton), an oral orexin receptor 2 agonist, for the treatment of narcolepsy type 1 in adults. This marks the first approval of a medicine to treat the underlying cause of the disease holistically rather than targeting individual symptoms. The approval is based on Phase 3 clinical trials demonstrating significant improvements in excessive daytime sleepiness, cataplexy, and quality of life. Takeda expects ORZEYFUL to be available following completion of the Drug Enforcement Administration scheduling process, which is anticipated within 90 days. The company stated that this approval is not expected to have a significant impact on its full-year consolidated financial forecast for the fiscal year ending March 31, 2027. Takeda operates in the pharmaceutical and biotechnology industry, focusing on discovering and delivering life-transforming treatments across various therapeutic areas.
Takeda Pharmaceutical Company Limited reported first-quarter results for the period ended June 30, 2026, showing revenue of JPY 1,219.9 billion, a 10.2% increase year-over-year driven by foreign exchange impacts. Operating profit rose 9.1% to JPY 201.4 billion, while net profit attributable to owners declined 8.9% to JPY 113.2 billion due to higher income tax expenses and restructuring costs. The company confirmed its full-year management guidance for the fiscal year ending March 31, 2027, projecting a low-single digit decline in Core Revenue growth, a 5% to 8% decline in Core Operating Profit growth, and a mid-teens percent decline in Core EPS growth on a constant exchange rate basis. Takeda operates as a global pharmaceutical company focused on the research, development, manufacturing, and sale of prescription drugs, vaccines, and plasma-derived therapies.