Takeda Pharm Stock Price, News & Analysis

The New England Journal of Medicine has published Phase 2b trial results for Takeda's (TAK) oveporexton (TAK-861), an oral orexin receptor 2 agonist for narcolepsy type 1 (NT1). The trial, involving 112 adults, demonstrated significant improvements in wakefulness and reduction in symptoms across all tested doses. Key findings include:

The drug achieved its primary endpoint with substantial increases in mean sleep latency, reaching levels similar to healthy individuals. Secondary endpoints showed significant reductions in excessive daytime sleepiness and weekly cataplexy rates. Quality of life measures also showed marked improvements across multiple symptom domains.

The treatment was generally well-tolerated, with most common side effects being insomnia (43%), increased urinary urgency (30%), and frequency (29%). Notably, 95% of participants continued into the long-term extension study. Takeda expects Phase 3 trial results in 2025, positioning oveporexton as a potential first-in-class therapeutic option for NT1.

Takeda (TAK) reported strong FY2024 financial results with core revenue growth of 7.4% (AER) and 2.8% (CER), driven by Growth & Launch Products momentum. Core Operating Profit increased by 4.9% at CER, supported by efficiency program cost savings. The company's core operating profit margin improved to 25.4%, up from 24.7%. Operating cash flow surged by 47.6% to ¥1,057.2 billion, while adjusted free cash flow jumped 171.3% to ¥769.0 billion. For FY2025, Takeda forecasts broadly flat revenue and core profit, reflecting VYVANSE generic impact offset by continued efficiency savings. The company announced a dividend increase from ¥196 to ¥200 per share. Notably, Takeda's pipeline includes up to six new molecular entities in Phase 3 development, with three Phase 3 data readouts recently completed or anticipated in FY2025.

BioLife Plasma Services, a Takeda company, has begun implementing the new Fresenius Kabi Adaptive Nomogram technology across its U.S. plasma donation centers. The system, used on the Aurora Xi Plasmapheresis System, is currently installed in over half of BioLife's centers and will be fully deployed by December 2025. Clinical trials demonstrated an impressive 11.5% increase in plasma collection per donor. The technology personalizes plasma donation by considering individual donor body attributes, optimizing collection efficiency. BioLife plans to achieve 100% coverage of personalized nomograms across all centers by March 2026, combining both Fresenius Kabi's Adaptive Nomogram and the Haemonetics Persona Nomogram systems.

Takeda Pharmaceutical Company has announced a significant $13.8 million grant initiative targeting U.S. nonprofit organizations. The funding focuses on two key areas: promoting healthy eating and expanding STEM education across the United States.

The company has also released its U.S. Community Impact Report, which details their progress in building a more equitable health ecosystem. This latest grant allocation reinforces Takeda's ongoing commitment to improving health through community-based programs.

The announcement, made from their Cambridge, Massachusetts headquarters, demonstrates Takeda's continued investment in local communities and public health initiatives. For detailed information, stakeholders can access the complete report on Takeda.com.

Protagonist Therapeutics (NASDAQ:PTGX) and Takeda (TSE:4502/NYSE:TAK) announced positive topline results from their Phase 3 VERIFY study of rusfertide in polycythemia vera (PV) patients. The study achieved its primary endpoint with 77% of rusfertide-treated patients showing clinical response compared to 33% in the placebo group.

The trial met all four key secondary endpoints, including the EU primary endpoint showing 0.5 phlebotomies per patient in the rusfertide arm versus 1.8 in the placebo arm. Rusfertide, a first-in-class hepcidin mimetic peptide therapeutic with FDA Orphan Drug and Fast Track designations, demonstrated favorable safety with mainly grade 1-2 injection site reactions.

Following these positive results, Protagonist will receive a $25 million milestone payment from Takeda upon completion of the VERIFY clinical study report.

Takeda (NYSE: TAK) has received EMA approval for an additional subcutaneous administration option of TAKHZYRO® (lanadelumab) for HAE patients aged 12 years and above. The new 2 mL pre-filled pen joins existing delivery options including 150 mg and 300 mg pre-filled syringes and 300 mg vials.

The approval expands treatment options for Hereditary Angioedema (HAE), a rare condition affecting approximately 1 in 50,000 people worldwide. TAKHZYRO is approved in the EU for routine prevention of recurrent HAE attacks in patients aged 2 years and older. The new pre-filled pen contains 300 mg of lanadelumab in 2 mL solution, with approval supported by clinical study data.

Takeda (TOKYO:4502/NYSE:TAK) has announced that Julie Kim, current president of Takeda's U.S. Business Unit, will succeed Christophe Weber as CEO when he retires in June 2026. The decision was made unanimously by the Board of Directors after a multi-year succession process evaluating both internal and external candidates.

Weber, who joined Takeda in 2014 and became CEO in 2015, has led the company's transformation into a global R&D-driven biopharmaceutical company. The timing of this succession aligns with Takeda's competitive growth outlook and new product launches expected from the second half of 2026.

Kim, who has been with Takeda's Executive Team since 2019 and leads the U.S. Business Unit since 2022, brings three decades of healthcare experience across various leadership positions. She will be proposed as a candidate for Board election at Takeda's Annual General Shareholders Meeting in June 2026.

Takeda reported strong Q3 FY2024 results with revenue growth of 9.8% at actual exchange rates and 4.5% at constant exchange rate. Growth & Launch Products showed impressive momentum with 14.6% growth at CER. Core Operating Profit increased by 10.1% at CER, with margin reaching 28.5%.

The company has raised its full-year outlook, increasing its Adjusted Free Cash Flow forecast by JPY 150.0 billion to JPY550.0-650.0 billion. Takeda announced a share buyback program of up to JPY 100.0 billion, demonstrating confidence in business momentum.

The pipeline shows strong progress with three Phase 3 data readouts expected in 2025, and eight regulatory filings planned between FY2025-FY2029. Six late-stage programs have potential peak revenues of USD 10-20 billion in total.

Takeda (TSE:4502/NYSE:TAK) has received approval from Japan's Ministry of Health for HYQVIA®, the first facilitated subcutaneous immunoglobulin (fSCIG) therapy for patients with agammaglobulinemia or hypogammaglobulinemia. The treatment combines Immunoglobulin 10% with Recombinant Human Hyaluronidase PH20, allowing larger volume infusions and reduced dosing frequency to once every 3-4 weeks versus weekly/bi-weekly with conventional treatments.

The approval is based on two Phase 3 studies in Japan involving 16 patients aged 2+ years, showing maintained IgG trough levels of 9.494g/L. Main adverse reactions included pyrexia (31.3%) and various infusion site reactions (12.5%). The approval expands Takeda's immunoglobulin therapy portfolio in Japan.