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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. 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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Elpiscience Biopharma, Ltd. (Ticker: -) and Astellas Pharma Inc. (Ticker: 4503) have announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. Elpiscience will receive up to US $37 million, including the upfront payment and license option fees, and is eligible to potentially receive more than US $1.7 billion in payments for the achievement of future development, regulatory, and commercial milestones. The collaboration aims to develop next-generation immuno-oncology therapies utilizing Elpiscience's Bispecific Macrophage Engager Platform (BiME®) to modulate tumor-associated macrophages and reprogram the tumor microenvironment status, offering new options for cancer patients who do not respond to existing cancer immunotherapies.
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Astellas Pharma Inc. (TSE: 4503) has completed the acquisition of Propella Therapeutics, Inc., making it a wholly owned subsidiary. The acquisition gives Astellas access to PRL-02, a next-generation androgen biosynthesis inhibitor for prostate cancer. The company paid approximately US $175 million for the acquisition, with limited financial impact expected for the fiscal year ending March 31, 2024.
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Astellas Pharma Inc. (TSE: 4503) contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium. The Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive scientific opinion for arpraziquantel to treat schistosomiasis in preschool-aged children. Astellas provided its innovative formulation technology to co-develop arpraziquantel as a member of the Consortium. The new pediatric formulation of arpraziquantel is palatable for very young children and is administered via a 150 mg dispersible tablet. Astellas has set a Strategic Goal to deepen its engagement in sustainability, and the positive CHMP scientific opinion represents a significant milestone in alignment with Astellas' Access to Health focus.
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Astellas Pharma Inc. (TSE: 4503) and Mission BioCapital BioLabs announced TippingPoint Biosciences and Altay Therapeutics as winners of the Astellas-sponsored 'Future Innovator Prize' at MBC BioLabs. The award provides one-year priority usage of MBC BioLabs' lab facility, access to Astellas' research capabilities, and business leaders' expertise to accelerate early research efforts.
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Astellas Pharma Inc. (TSE: 4503) has announced the approval of VEOZATM (fezolinetant) 45 mg once daily by the European Commission for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause. VMS, also known as hot flashes and/or night sweats, affect more than half of women aged 40 to 64 years, with rates in Europe ranging from 56% to 97%. The prevalence of moderate to severe VMS in postmenopausal women in Europe has been reported at 40%. The approval follows positive clinical trial results from the BRIGHT SKY™ program, with fezolinetant demonstrating efficacy and safety for the treatment of VMS. Astellas has already reflected the impact from this matter in its financial forecast of the current fiscal year ending March 31, 2024.
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Astellas Pharma Inc. (TSE: 4503) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause in women unsuitable for hormone therapy. The study of over 450 women met all primary and secondary endpoints at 24 weeks, demonstrating statistically significant reductions in the frequency and severity of VMS, as well as patient-reported sleep disturbance. Treatment-emergent adverse events were reported by 65% of patients in the fezolinetant group compared to 61% in the placebo group.
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PFE and Astellas Pharma Inc. (4503) announced that the FDA approved a supplemental New Drug Application for XTANDI, making it the first and only androgen receptor signaling inhibitor approved for nonmetastatic castration-sensitive prostate cancer treatment with or without a GnRH analog therapy. This approval follows expedited development and review programs based on results from the Phase 3 EMBARK trial.
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FAQ
What is the current stock price of Astellas Pharma (ALPMY)?
The current stock price of Astellas Pharma (ALPMY) is $9.73 as of February 21, 2025.
What is the market cap of Astellas Pharma (ALPMY)?
The market cap of Astellas Pharma (ALPMY) is approximately 16.9B.
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.
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