Takeda Pharmaceutical Company Limited American Depositary Shares (each (TAK)

Rusfertide met all primary and secondary endpoints in a Phase 3 trial for polycythemia vera, with strong efficacy and safety results, earning Protagonist $25 million.

Protagonist Therapeutics, Inc. (“Protagonist”) (NASDAQPTGX) and Takeda (TSE:4502/NYSE:TAK) today announced positive topline results for the Phase 3 VERIFY study, in which phlebotomy-dependent patients with polycythemia vera (PV) were randomized to treatment with either rusfertide or placebo, as an add-on to standard of care treatment. The study met its primary endpoint and all four key secondary endpoints. Rusfertide is a first-in-class investigational hepcidin mimetic peptide therapeutic, which has received Orphan Drug designation and Fast Track designation from the U.S. Food & Drug Administration (FDA).

Takeda (TOKYO:4502/NYSE:TAK) announced today that its Board of Directors made the decision unanimously to appoint Julie Kim, currently president of Takeda’s U.S. Business Unit, as the successor to Christophe Weber, Takeda’s president, chief executive officer (CEO) and representative director, when Mr. Weber retires from the company in June 2026. Mrs. Kim will be proposed as a candidate for election to the Board at Takeda’s Annual General Shareholders Meeting held in June 2026. Mr. Weber will not hold a Board seat after retiring from Takeda.

Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the third quarter of fiscal year 2024 (nine months ended December 31, 2024) showing continued advancement of its Growth & Launch Products, which delivered double-digit growth of 14.6% at CER. The company has upgraded its full year outlook for growth, reflecting strong year-to-date product performance and OPEX efficiencies, as well as revised foreign exchange assumptions.

Neurocrine Biosciences advances Phase 3 plans for osavampator after achieving Phase 2 success in major depressive disorder, amending its Takeda deal.

The U.S. Food and Drug Administration announced a ban on Red No. 3, an artificial food coloring linked to cancer in animal studies, effective Jan. 15, 2027.

Takeda's HYQVIA receives approval in Japan for treating immunodeficiencies, offering a more convenient, less frequent subcutaneous infusion option.

Takeda (TSE:4502/NYSE:TAK) today announced that the Japanese Ministry of Health, Labour and Welfare has approved the use of HYQVIA® [Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase] in patients with agammaglobulinemia or hypogammaglobulinemia1, disorders characterized by very low or absent levels of antibodies and an increased risk of serious recurring infection caused by primary immunodeficiency (PID) or secondary immunodeficiency (SID)2. The approval marks availability of the first and only facilitated subcutaneous immunoglobulin (fSCIG) therapy as a treatment option for appropriate patients in Japan.

Teva and Sanofi report positive Phase 2b data for duvakitug, showing significant remission in UC and CD patients, boosting analyst confidence and price targets.

— US$10 million milestone payment to HUTCHMED follows first national reimbursement in Europe —

Takeda (TSE:4502/NYSE:TAK) will host an investor R&D Day today beginning at 8:30 a.m. JST in Tokyo. The meeting will focus on programs in the company’s late-stage pipeline, the transformative value they could deliver to patients, and the market opportunities they represent.

Takeda inks a licensing deal with Keros for elritercept, a late-stage anemia drug, and plans a Phase 3 trial in myelodysplastic syndromes.

Takeda (TSE:4502/NYSE:TAK) today announced that it has entered into an exclusive licensing agreement with Keros Therapeutics, Inc. (Nasdaq: KROS) to further develop, manufacture and commercialize elritercept worldwide outside of mainland China, Hong Kong and Macau.

— Launch follows approval by Japanese Ministry of Health, Labour and Welfare in September 2024 —

AC Immune reports interim results from Phase 2 trial of ACI-7104.056 active immunotherapy for early Parkinson's disease.

Global leaders gather at COP29 to address climate change, carbon market mechanisms, and climate finance. Urgency and controversy at a fossil fuel reliant host country, but focus on establishing rules for a global carbon market.

— US$20 million payment based on sales of FRUZAQLA® in metastatic colorectal cancer —

Takeda (TOKYO:4502/NYSE:TAK) today announced earnings results for the first half of fiscal year 2024 (six months ended September 30, 2024), with continued momentum in its Growth & Launch Products driving growth. The company has upgraded its full year forecasts and Management Guidance to reflect stronger than anticipated first-half performance (including milder than anticipated generic erosion of VYVANSE® in the U.S.) and revised foreign exchange assumptions.

Takeda (TOKYO:4502/NYSE:TAK) and Boston Medical Center (BMC) today announced a new collaboration focused on identifying innovative solutions that can reduce hard-to-abate greenhouse gas (GHG) emissions in the health care sector. The collaboration between Takeda and BMC aims to reduce the GHG emissions caused by disposal of regulated medical waste, such as pharmaceutical packaging and single-use plastics, which are among the most difficult environmental challenges facing the industry. The effort will also seek to scale the interventions developed through the collaboration by sharing best practices to help other organizations adopt and learn new ways to decarbonize in their operations to drive wider health care ecosystem impact.

HC Wainwright has initiated coverage on Alumis, highlighting the biopharmaceutical company's lead drug candidate, ESK-001. The analyst notes ESK-001's superior clinical data compared to Bristol Myers Squibb's Sotyktu, indicating strong growth potential in the TYK2 market.

Johnson & Johnson has discontinued its Phase 2 study of mosnodenvir, an investigational antiviral candidate for dengue prevention, as part of a strategic shift in its R&D portfolio. Final efficacy data from the study will be available after analysis.

Takeda (TSE:4502/NYSE:TAK) today announced that it has received approval from the Japanese Ministry of Health, Labour and Welfare to manufacture and market FRUZAQLA Capsules 1mg/5mg (generic name: fruquintinib), a selective oral inhibitor of vascular endothelial growth factor receptor (VEGFR) -1, -2 and -3, for the treatment of advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and that has progressed after chemotherapy.

— Approval based on results from global Phase III FRESCO-2 trial in patients with previously treated metastatic colorectal cancer —