Core Insights - Zolbetuximab is the first and only therapy approved in the EU targeting claudin 18.2, a biomarker present in 38% of advanced gastric cancer patients [1][2] - The European Commission approved VYLOY™ (zolbetuximab) for first-line treatment in combination with chemotherapy for specific gastric cancer patients [1][2] - Clinical trials demonstrated significant improvements in progression-free survival (PFS) and overall survival (OS) with zolbetuximab compared to standard treatments [2][3] Company Developments - Astellas Pharma announced the approval of zolbetuximab in the EU, following earlier approvals in the UK and Japan [3] - The company has adjusted its financial forecast for the fiscal year ending March 31, 2025, to reflect the impact of this approval [4] - Astellas is collaborating with Roche on a companion diagnostic test to identify eligible patients for zolbetuximab treatment [5] Clinical Trial Results - The SPOTLIGHT trial showed a median PFS of 10.61 months for zolbetuximab plus mFOLFOX6 compared to 8.67 months for placebo [2][7] - The GLOW trial reported a median PFS of 8.21 months for zolbetuximab plus CAPOX versus 6.80 months for placebo [2][8] - Both trials indicated similar rates of serious treatment-emergent adverse events between zolbetuximab and control groups [2] Market Context - Gastric and gastroesophageal junction cancers are significant health concerns, with over 135,000 new cases diagnosed in Europe in 2022 [6] - These cancers are the sixth leading cause of cancer-related deaths in Europe, highlighting the need for effective treatment options [6] - The average five-year survival rate for patients with these cancers in Europe is only 26%, emphasizing the urgency for new therapies [6]

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 ...

Core Insights - Astellas has opened a new LEED-certified facility in Cambridge, which includes the first U.S.-based SakuLab™ and the Engineered Small Molecules (ESM) unit, focusing on targeted protein degradation to address previously 'undruggable' targets [1][2] - The new facility will accommodate approximately 400 employees from various departments, enhancing collaboration and innovation through shared R&D resources and flexible workspaces [1] - Astellas aims to strengthen partnerships with local academic institutions and biotech innovators, particularly in oncology, ophthalmology, and rare diseases [2][4] Company Overview - Astellas Pharma Inc. operates in over 70 countries and focuses on addressing high unmet medical needs through its Focus Area Approach, which emphasizes Biology and Modality [5] - The company is also developing Rx+® healthcare solutions that integrate its expertise with advanced technologies from external partners [5] Innovation and Collaboration - The SakuLab initiative, inspired by the Japanese word "saku" meaning "to bloom," is designed to foster innovation and collaboration in shared workspaces [3] - The new Cambridge facility complements Astellas' existing presence in Massachusetts, including the Astellas Institute of Regenerative Medicine launched in 2020 [4]

- 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 ...

Financial Performance - Revenue increased by 262% YoY, reaching 4731 billion yen, with a foreign exchange impact of +454 billion yen[4] - Core operating profit increased by 205% YoY to 883 billion yen, with a foreign exchange impact of +116 billion yen[4] - Strategic Brands expanded to 750 billion yen, representing a threefold increase YoY of approximately +500 billion yen[4, 5] Key Products - XTANDI contributed significantly to overall revenue growth, particularly in the US, with sales of 2242 billion yen, a 29% increase YoY (+502 billion yen)[4, 5] - PADCEV global sales reached 384 billion yen, a 152% increase YoY (+232 billion yen)[6] US sales were $174 million (+128%), and EST sales were €45 million (+178%)[7] - IZERVAY US sales were $82 million, with a market share of approximately 35% in Q1/FY2024, representing a QoQ growth of +73%[10, 11] - VEOZAH global sales were 66 billion yen, a 972% increase YoY (+60 billion yen)[6] US sales were $39 million (+778%), and EST sales were €3 million (+3)[9] Cost Items - SG&A expenses increased by 230% YoY to 2069 billion yen, with a foreign exchange impact of +208 billion yen[4] Excluding US XTANDI co-pro fee, SG&A expenses increased by 175% YoY (+217 billion yen)[4] - R&D expenses increased by 344% YoY to 868 billion yen, with a foreign exchange impact of +69 billion yen[4] Pipeline and Strategy - The company is pursuing product value maximization for ZOLBETUXIMAB / VYLOY as a first-in-class anti-CLDN182 treatment, with a regulatory decision anticipated for Q4/FY2024[15] - A new Phase 3 study for ZOLBETUXIMAB / VYLOY in combination with CPI and chemotherapy is planned to start in 1H/CY2025[15] - The company is investing in business growth, aiming for higher dividend increases aligned with robust profit growth forecasts[27]

- 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/ -- ...

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S. TOKYO, May 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class i ...