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Astellas Pharma Inc. - ALPMY STOCK NEWS

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Astellas Pharma Inc. is a global pharmaceutical company with operations in over 70 countries. The company focuses on creating innovative drugs to treat diseases with high unmet medical needs by emphasizing Biology and Modality. Beyond traditional pharmaceuticals, Astellas is exploring Rx+® healthcare solutions in collaboration with cutting-edge technology partners. Astellas recently opened a state-of-the-art West Coast Innovation Center in South San Francisco, enhancing its commitment to biotech innovation.

The company is actively involved in research and development, with recent advancements in cancer therapies like zolbetuximab, a monoclonal antibody targeting gastric and gastroesophageal cancers. Astellas' collaborations with Pfizer and Merck, as well as YASKAWA Electric Corporation, demonstrate its commitment to pioneering research and creating new treatment paradigms by integrating pharmaceutical and robotics technologies.

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Astellas Pharma announced that the FDA has acknowledged the resubmission of their Biologics License Application (BLA) for zolbetuximab, a CLDN18.2-targeted monoclonal antibody.

If approved, it will be the first therapy for patients with advanced gastric and gastroesophageal junction cancers in the U.S. The FDA has set a target action date of November 9, 2024. A previous FDA review in January 2024 highlighted third-party manufacturing issues, not clinical concerns.

The BLA is based on Phase 3 trials (SPOTLIGHT and GLOW), which showed that 38% of patients had CLDN18.2 positive tumors. Zolbetuximab was recently approved in Japan for similar indications. Financial expectations related to this acknowledgment have already been factored into Astellas' forecasts for the fiscal year ending March 31, 2025.

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Astellas Pharma has signed a non-binding memorandum of understanding with YASKAWA Electric to explore creating an advanced cell therapy ecosystem by integrating pharmaceutical and robotics technologies. The collaboration aims to digitize cell manufacturing processes using YASKAWA's humanoid robot, Maholo. This technology could streamline research to commercialization, potentially offering a platform for startups and academia. Astellas will provide cell manufacturing technology and regulatory insights, while YASKAWA will contribute cutting-edge robotics. The financial impact on Astellas for the fiscal year ending March 31, 2025, is expected to be minor.

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Astellas Pharma Inc. will present new research at the 2024 ASCO Annual Meeting showcasing scientific advancements in its oncology portfolio. The company will share data from pivotal trials across various hard-to-treat cancers like prostate, urothelial, and gastric/gastroesophageal junction cancers. Key highlights include Phase 3 trial data supporting enfortumab vedotin, final overall survival results from the SPOTLIGHT study on zolbetuximab, and post-hoc analyses of the EMBARK trial on enzalutamide. Astellas continues to focus on innovative therapies for cancer patients.

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Astellas Pharma Inc. unveiled a new $90 million West Coast Innovation Center in the South San Francisco Biotech Corridor. The 154,000 square-foot lab and office facility serves as a central location for Astellas' West Coast cell and gene therapy research and business development operations. The center aims to enhance collaboration, productivity, and innovation to deliver innovative treatments and value to patients worldwide.

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Astellas Pharma's XTANDI (Enzalutamide) receives European Commission approval for use in additional recurrent early prostate cancer treatment setting, making it the first novel hormone therapy available for high-risk biochemical recurrent non-metastatic hormone-sensitive prostate cancer in the EU. The approval is based on positive Phase 3 EMBARK study results, showing XTANDI alone or in combination with leuprolide reduces the risk of metastasis or death. The European Association of Urology updated their treatment guidelines to include enzalutamide for men with high-risk BCR nmHSPC, filling a treatment gap in this patient population.
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Takeda, Astellas, and Sumitomo Mitsui Banking have announced a master agreement to establish a joint venture company dedicated to the incubation of early drug discovery programs in Japan. The new company aims to advance innovative drug discovery programs, foster entrepreneurship, and create start-up companies to unleash the potential of the drug discovery ecosystem in Japan.
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Astellas Pharma Inc. announces the acceptance of the sBLA for enfortumab vedotin with KEYTRUDA as a combination therapy for first-line treatment of urothelial cancer in China, potentially offering an alternative to platinum-containing chemotherapy. The pivotal trial results show significant improvements in overall and progression-free survival, potentially changing the treatment paradigm for this life-threatening condition.
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Iveric Bio, An Astellas Company, receives a permanent J-code (J2782) effective April 1, 2024, for IZERVAY™, a treatment for geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The J-code will streamline billing and reimbursement processes, increasing patient access to the FDA-approved treatment.
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Astellas Pharma Inc. announces MHLW approval of VYLOY for gastric cancer treatment, making it the first CLDN18.2-targeted therapy globally. Approval based on successful Phase 3 trials showing significant improvement in progression-free and overall survival rates.
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Astellas Pharma Inc. announced a positive CHMP opinion recommending approval of XTANDI for the treatment of high-risk biochemical recurrent non-metastatic hormone sensitive prostate cancer patients in the EU. This decision could make XTANDI the first NHT treatment available for this patient population in the EU by June 2024. The positive opinion is based on Phase 3 EMBARK trial results, indicating potential approval for XTANDI in the EU and other regions beyond the US, where it was already approved for a similar indication.
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FAQ

What is Astellas Pharma Inc. known for?

Astellas Pharma Inc. is recognized as a leading global pharmaceutical company operating in over 70 countries, focusing on developing innovative drugs for diseases with high unmet medical needs.

What recent achievements has Astellas Pharma Inc. made?

Astellas recently inaugurated a modern West Coast Innovation Center in South San Francisco, enhancing its presence in the biotech ecosystem.

What is zolbetuximab, and why is it significant?

Zolbetuximab is an investigational monoclonal antibody aimed at treating gastric and gastroesophageal cancers and is a testament to Astellas' commitment to pioneering cancer therapies.

How does Astellas collaborate with other companies like Pfizer, Merck, and YASKAWA Electric Corporation?

Astellas collaborates with Pfizer, Merck, and YASKAWA Electric Corporation to advance research and development in innovative treatments through partnerships that integrate pharmaceutical and robotics technologies.

What is Astellas Pharma Inc.'s focus beyond traditional pharmaceuticals?

Astellas is exploring Rx+® healthcare solutions with cutting-edge technology partners, aiming to create innovative treatment approaches beyond traditional pharmaceuticals.

Astellas Pharma Inc.

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