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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 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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Astellas Pharma US, Inc. receives FDA approval for CRESEMBA to treat serious fungal infections in children, granting seven years of market exclusivity. The drug is the first to be approved for pediatric patients as young as one, providing a vital treatment option for rare and life-threatening infections.
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Astellas Pharma Inc. announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, a nonhormonal compound for treating vasomotor symptoms in Japanese women. The company aims to provide a novel treatment option for menopausal symptoms.
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Astellas Pharma Inc. receives priority review for PADCEV™ and KEYTRUDA® combination therapy for urothelial cancer treatment, based on positive Phase 3 trial results.
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Astellas Pharma Inc. and Kelonia Therapeutics announce a research collaboration to develop novel Immuno-Oncology therapeutics using Xyphos Biosciences' ACCEL™ technology and Kelonia's iGPS® platform. The agreement includes upfront payments of US $40 million for the first program, potential milestones and contingency payments of up to US $800 million, and tiered royalties on net sales.
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Astellas Pharma Inc. announces the addition of a Chief Digital & Transformation Officer to its top management effective April 1, 2024. Nick Eshkenazi will be appointed to the position, bringing experience in driving complex business transformation and digital technology in various industries.
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Astellas announces return to Super Bowl for educational initiative, aiming to reach a large audience with important healthcare information.
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Astellas Pharma Inc. submits a Supplemental New Drug Application for PADCEV with KEYTRUDA as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer in Japan. The pivotal Phase 3 trial found that the combination significantly extended overall and progression-free survival compared to platinum-containing chemotherapy. If approved, this combination would offer an alternative to the current standard of care in first-line urothelial cancer treatment. The submission is based on results from the EV-302 clinical trial, showing improved survival and disease progression compared to chemotherapy. The safety results were consistent with previous reports, and the combination therapy is under review by the European Medicines Agency and has been approved by the U.S. FDA.
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Astellas Pharma Inc. announces a strategic collaboration with Mass General Brigham to advance translational medicine and early development of novel therapies in oncology, rare disease, and cell and gene therapy. The alliance aims to accelerate innovation, translate research into clinical trials, leverage scientific and clinical expertise, and enhance patient care. Mass General Brigham is a leading academic medical center in the US with extensive research in oncology, rare disease, and cell and gene therapy.
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Astellas Pharma Inc. (TSE: 4503) receives a complete response letter from the FDA regarding the Biologics License Application for zolbetuximab, an investigational agent for the treatment of patients with advanced gastric or GEJ cancer. The FDA cannot approve the BLA due to unresolved deficiencies in a third-party manufacturing facility. No concerns were raised about the clinical data, and Astellas is working to resolve the feedback. The impact on financial results is expected to be limited.
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FAQ
What is the current stock price of ASTELLAS PHARMA UNSP/ADR (ALPMY)?
The current stock price of ASTELLAS PHARMA UNSP/ADR (ALPMY) is $9.44 as of January 23, 2025.
What is the market cap of ASTELLAS PHARMA UNSP/ADR (ALPMY)?
The market cap of ASTELLAS PHARMA UNSP/ADR (ALPMY) is approximately 17.5B.
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 UNSP/ADR