- Zolbetuximab is currently the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer1,2 - Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progressionfree survival and overall survival in Phase 3 trials1,2 TOKYO, Sept. 20, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Co ...

Product Overview - DIGITIVA™ is a non-invasive digital health solution for heart failure management, classified as a Class I Software as a Medical Device (SaMD) and exempt from FDA's 510(k) premarket submission [1] - The solution integrates three components: CORE 500™ Digital Stethoscope, a smartphone app for heart failure patients, and educational content from the American Heart Association, supported by a clinical review team [2] - DIGITIVA aims to improve clinical outcomes by enabling at-home disease monitoring and facilitating timely physician intervention [2] Market and Industry Context - Heart failure affects over 64 million people globally, with 6.9 million cases in the U.S. (2020 estimate), projected to increase by 24% to nearly 8.5 million by 2030 due to population aging and growth [3] - The solution represents a significant milestone for Astellas as its first digital health offering in the U.S., developed within the Rx+ Business Accelerator to integrate innovative technology with patient support [3] Technology and Partnerships - DIGITIVA leverages Eko Health's CORE 500 Digital Stethoscope and AI technology, combined with Welldoc's AI-driven platform for real-time, personalized feedback and data-driven clinical insights [4][5] - The collaboration with Eko Health and Welldoc aims to bridge the gap between home and clinic care, enabling proactive management of heart failure [4][5] Company Background - Astellas Pharma operates in over 70 countries, focusing on creating new drugs for diseases with high unmet medical needs and developing Rx+ healthcare solutions by combining expertise with cutting-edge technology [8] - Eko Health, with over $165 million in funding, provides FDA-cleared digital stethoscopes and AI-powered analysis used by over 500,000 healthcare professionals worldwide [9] - Welldoc, a leader in digital health, offers AI-powered coaching for cardiometabolic conditions and has achieved 11 FDA 510(k) clearances and 45 patents for its advanced AI technology [10][11] Financial Impact - Astellas has already incorporated the financial impact of DIGITIVA's FDA listing into its fiscal year 2025 forecast [5]

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types - TOKYO, Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September. Eight ...

The new LEED-certified construction is home to the company's first U.S.-based SakuLab™, a shared laboratory space for highly innovative external partners. The new ALSC will also house the company's Engineered Small Molecules (ESM) unit which focuses on advancing research into targeted protein degradation, a novel treatment approach aimed at removing specific proteins from cells to unlock targets that have previously been considered 'undruggable.' Approximately 400 Astellas employees will operate out of the ...

- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood - Pooled data from three SKYLIGHT™ studies assess safety and tolerability in Hispanic/Latina women - Responder analysis from DAYLIGHT™study evaluates reduction in VMS frequency in women unwilling or unable to take hormone therapy TOKYO, Sept. 4, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki O ...

- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1 - European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1 TOKYO, Aug. 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission has granted Marketing Authorization for PADC ...

Astellas Pharma Inc. (OTCPK:ALPMF) Q1 2024 Earnings Conference Call August 1, 2024 3:00 AM ET Company Participants Hiromitsu Ikeda - Chief Communications and IRO Tadaaki Taniguchi - CMO Claus Zieler - CCO Atsushi Kitamura - CFO Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Seiji Wakao - JPMorgan Securities Akinori Ueda - Goldman Sachs Securities Kasumi Haruta - UBS Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Hyogo - ...

Q1/FY2024 FINANCIAL RESULTS ENDED JUNE 30, 2024 Atsushi Kitamura Chief Financial Officer (CFO) Astellas Pharma Inc. August 1, 2024 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the i ...

- If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2- targeted therapy approved in the European Union TOKYO, July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-i ...

- If approved, enfortumab vedotin in combination with pembrolizumab will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1 TOKYO, July 26, 2024 /PRNewswire/ -- ...