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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.
Astellas Pharma and Seagen announce that the CHMP of the EMA has reaffirmed its positive opinion for PADCEV (enfortumab vedotin) as a monotherapy for adults with locally advanced or metastatic urothelial cancer previously treated with platinum chemotherapy and a PD-1/L1 inhibitor. This endorsement follows a review of updated safety data and could lead to PADCEV being the first antibody-drug conjugate authorized in the EU for this cancer type. The final decision from the European Commission is awaited.
Seagen and Astellas Pharma announced results from the EV-103 trial evaluating enfortumab vedotin for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin therapy. Data presented at the 2022 ASCO Genitourinary Cancers Symposium showed that 36.4% of the 22 patients achieved a pathologic complete response, with 50% experiencing tumor downstaging. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). Ongoing phase 3 trials will further investigate the drug's efficacy in combination with pembrolizumab.
Astellas Pharma and Seagen reported initial results from Cohort H of the EV-103 trial on PADCEV® (enfortumab vedotin-ejfv) for muscle-invasive bladder cancer (MIBC) patients ineligible for cisplatin chemotherapy. Of 22 patients analyzed, 36.4% achieved a pathologic complete response, with 50% showing tumor size reduction. All patients proceeded to surgery without delays. Adverse events included fatigue (45.5%) and alopecia (36.4%). The results will be presented at the ASCO Genitourinary Cancers Symposium on February 18, 2022.
Astellas Pharma announced positive interim safety data from the FORTIS trial for AT845, a gene replacement therapy for Late-Onset Pompe Disease (LOPD). This Phase I/II trial aims to assess the safety and efficacy of AT845 in adults. As of December 3, 2021, four participants were enrolled, with no serious adverse events reported. One participant had elevated transaminases, a known immune response. The therapy could address the unmet needs of LOPD patients where enzyme replacement therapy is currently the only approved treatment.
Astellas Pharma and Seagen announced that the European Medicines Agency (EMA) has positively evaluated PADCEV (enfortumab vedotin) for advanced urothelial cancer patients who have undergone platinum-based chemotherapy and PD-1/L1 inhibitors. This marks a significant step as it could be the first antibody-drug conjugate approved in the EU for this condition. The recommendation is based on the Phase 3 EV-301 trial data, highlighting overall survival improvements. The final decision by the European Commission is awaited. Bladder cancer, the most common type of bladder cancer, sees high incidence and mortality rates in Europe.
Astellas Pharma and Seagen announced a positive opinion from the European Medicines Agency's CHMP, recommending approval for PADCEV™ (enfortumab vedotin) as a treatment for adult patients with advanced urothelial cancer previously treated with chemotherapy and a PD-1/L1 inhibitor. This marks a significant step toward making PADCEV the first authorized ADC for advanced urothelial cancer in the EU, addressing a crucial treatment gap. The CHMP's recommendation is based on data from the phase 3 EV-301 trial, which showed improved overall survival compared to chemotherapy.
Astellas Venture Management and MBC BioLabs announced Vcreate and Weatherwax Biotechnologies as winners of the Future Innovator Prize, granting them one year of access to MBC BioLabs' facilities and Astellas' R&D capabilities. Vcreate focuses on T-cell therapies for untreatable cancers, utilizing advanced screening assays. Weatherwax aims to develop novel bifunctional drugs for previously 'undruggable' oncology targets. Astellas emphasizes its commitment to innovative science for patient benefits. Both companies will receive support from Astellas throughout their residency.
Astellas Pharma and Dyno Therapeutics have entered a partnership aimed at developing next-generation adeno-associated virus (AAV) vectors for gene therapy, focusing on skeletal and cardiac muscle. Signed on November 23, the agreement allows Dyno to leverage its CapsidMap platform to design improved AAV capsids. Astellas will handle preclinical, clinical, and commercialization efforts. Dyno will receive an $18 million upfront payment and potential earnings exceeding $1.6 billion, including milestone payments and royalties.
Astellas Pharma announced its participation in the 63rd American Society of Hematology (ASH) Annual Meeting, taking place from December 11-14 in Atlanta, GA. The company will present 11 abstracts on acute myeloid leukemia (AML), including key data on gilteritinib from Phase 3 trials LACEWING and COMMODORE. The research will cover various patient stages from newly diagnosed to relapsed and refractory cases. Additionally, Astellas will introduce preclinical data on ASP8731, a novel treatment for sickle cell disease that may alleviate related symptoms.
Astellas Venture Management has announced the winners of the Future Innovator Prize, awarding Thymmune Therapeutics and M13 Therapeutics. These emerging biotech companies gain a year of access to LabCentral's state-of-the-art lab and Astellas’ research capabilities. Thymmune focuses on cell therapies for immunologic disorders, while M13 develops non-viral gene therapies for genetic diseases. This initiative underscores Astellas' commitment to supporting innovative science and addressing unmet medical needs.
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