Takeda Pharmaceutical Company Limited American Depositary Shares (each representing 1/2 of a share of - TAK STOCK NEWS

Takeda reported strong H1 FY2024 results with revenue growth of +13.4% (AER) and +5.0% (CER), driven by Growth & Launch Products (+18.7% CER). Core Operating Profit increased by +12.9% CER with a margin of 30.2%. The company upgraded its FY2024 outlook due to stronger performance and milder VYVANSE generic erosion. Notable achievements include ENTYVIO's double-digit growth, ADZYNMA's EU approval, FRUZAQLA's Japan launch, and TAK-861's Phase 3 trial initiation for narcolepsy. The revised guidance projects flat to slightly increasing core revenue, with core operating profit showing a mid-single-digit decline.

Takeda and Boston Medical Center (BMC) announced a three-year collaboration to reduce greenhouse gas emissions in healthcare, focusing on regulated medical waste and pharmaceutical packaging. The initiative aims to identify and pilot decarbonization solutions that can be shared across the healthcare ecosystem. BMC will conduct waste audits in clinical areas to identify emission hotspots and test new technologies. This partnership supports Takeda's goal to achieve net-zero emissions in operations by 2035 and across its value chain by 2040, recently validated by the Science Based Targets initiative.

Ciconia Bioventures Inc., a joint venture company, has been established based on a master agreement signed by Takeda Pharmaceutical Company (TSE: 4502/NYSE: TAK), Astellas Pharma Inc. (TSE: 4503), and Sumitomo Mitsui Banking . The company aims to translate innovative technologies and drug discovery programs from Japan into clinical applications, focusing on:

• Covering the entire process from early drug discovery research to establishing biotech startups
• Formulating development strategies and enhancing the value of promising drug discovery seeds
• Integrating R&D funding and experienced management teams to launch new startups
• Collaborating with academia, biotech ventures, and pharmaceutical companies across Japan

Ciconia's goal is to advance innovative drug discovery programs, incubate globally competitive drug discovery technology, and foster entrepreneurship in Japan's pharmaceutical sector.

Tempus AI, Inc. (NASDAQ: TEM) announces an expanded collaboration with Takeda to enhance oncology research and development. The partnership leverages Tempus' de-identified multimodal datasets and biological modeling capabilities to advance Takeda's cancer therapeutics pipeline. Takeda researchers will use Tempus' analytics platform, Lens, to access de-identified patient records and AI-enabled tools.

The collaboration includes a multi-phase biological modeling project using one of the world's largest repositories of patient-derived tumor organoids. Tempus is working with Takeda on a panel of 60 organoids spanning 10 cancer indications to evaluate preclinical candidates. This approach aims to enhance drug effectiveness prediction and guide early candidate prioritization.

Initial work has already yielded research to be presented at an upcoming medical congress, demonstrating the potential of this data-first approach in accelerating insights for drug development.

Takeda (TSE:4502/NYSE:TAK) has received approval from the Japanese Ministry of Health, Labour and Welfare for FRUZAQLA (fruquintinib), a selective oral inhibitor of VEGFR-1, -2 and -3, to treat advanced or recurrent colorectal cancer (CRC) that is neither curable nor resectable and has progressed after chemotherapy. The approval is based on the FRESCO-2 trial, a global Phase 3 study that met all primary and key secondary efficacy endpoints.

FRUZAQLA demonstrated consistent benefits regardless of previous therapies and showed a manageable safety profile. It is the first novel targeted therapy in Japan for metastatic CRC regardless of biomarker status in over a decade. The treatment offers new hope for patients with metastatic CRC, addressing the need for new options in a disease with low 5-year survival rates.

Takeda (TSE:4502/NYSE:TAK) will present additional data from Phase 2b trials and long-term extension study of TAK-861, an investigational oral orexin receptor 2 selective-agonist, for narcolepsy at Sleep Europe 2024. The presentations will highlight TAK-861's impact on daily functioning, cognition, and sleep quality in narcolepsy type 1 (NT1) and type 2 (NT2) patients. Based on positive Phase 2b results, Takeda has initiated the FirstLight Study, a global Phase 3 trial evaluating TAK-861 in adults with NT1. The drug aims to address the underlying pathophysiology of NT1 and could potentially become the first treatment to do so. Takeda is also developing assets for narcolepsy type 2 and idiopathic hypersomnia.

Takeda has committed JPY4.6 billion (approx. USD 32 million) to five new Global Corporate Social Responsibility (CSR) partners, aiming to improve health systems in low and middle-income countries. This initiative is expected to impact 27 million people across 93 countries by 2030. The new partnerships will focus on:

1. Expanding vaccine access through pharmacy-based immunization in Africa
2. Integrating community-driven healthcare in rural South Africa
3. Increasing care access for women and girls in conflict-affected areas
4. Building skilled health workforces in African countries
5. Strengthening national health systems for disease outbreak response

These partnerships were selected by over 22,000 Takeda employees worldwide, demonstrating the company's commitment to collaborative global corporate giving. Since 2016, Takeda's Global CSR Program has reached 17.8 million direct beneficiaries in 93 countries, contributing to various aspects of health system strengthening.

Takeda has received European Commission approval for ADZYNMA, the first and only recombinant ADAMTS13 replacement therapy for congenital thrombotic thrombocytopenic purpura (cTTP). cTTP is an ultra-rare, potentially fatal blood-clotting disorder with treatment options. The approval is based on the totality of evidence, including results from the first randomized, controlled, open-label, crossover Phase 3 cTTP trial.

Key points:

• ADZYNMA is now approved for treating ADAMTS13 deficiency in children and adult patients with cTTP in the EU
• The Phase 3 trial showed no acute TTP events in patients receiving ADZYNMA prophylactic treatment
• ADZYNMA demonstrated a favorable safety profile compared to plasma-based therapies
• Takeda is also investigating recombinant ADAMTS13 for immune-mediated TTP in an ongoing Phase 2b trial

Takeda reported strong Q1 FY2024 results, with revenue growth of 14.1% at AER and 2.1% at CER. Growth & Launch Products drove performance, increasing 17.8% at CER and representing 46% of total revenue. Core Operating Profit rose 4.5% at CER, with a margin of 31.6%. The company maintained its full-year forecast and management guidance.

Key highlights include:

• Geographic expansion with approvals of LIVTENCITY in Japan and FRUZAQLA in EU
• Positive Phase 2b data for TAK-861 in narcolepsy type 1 and mezagitamab for ITP
• Q1 revenue of 1,208.0 billion yen and Core Operating Profit of 382.3 billion yen
• Core EPS of 176 yen, up 17.5% year-over-year