ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

Astellas Pharma announced a voluntary pause in the ASPIRO clinical trial for AT132, a gene therapy for X-linked Myotubular Myopathy (XLMTM), following a serious adverse event involving abnormal liver function in a participant. This pause affects screening and dosing of new participants, though no Investigational New Drug clinical hold has been issued yet. Since the trial began, 24 participants have received AT132, with past adverse liver events leading to fatalities. Astellas continues to monitor existing participants and will provide updates on the investigation.

Astellas Pharma and FibroGen announced the European Commission's approval of EVRENZO™ (roxadustat) for treating symptomatic anemia linked to chronic kidney disease (CKD) in adults. This makes roxadustat the first oral HIF-PH inhibitor available in the EU, enhancing treatment options for CKD patients. The approval follows a positive opinion from the EMA and triggers a $120 million milestone payment from Astellas to FibroGen. The comprehensive Phase 3 program involved 9,600 patients and demonstrated efficacy in maintaining target hemoglobin levels.

Astellas Venture Management LLC has collaborated with LabCentral to launch the Future Innovator Prize, aimed at supporting early-stage life-sciences startups. This initiative offers one-year access to LabCentral’s lab facilities in Cambridge, Massachusetts, along with Astellas' research capabilities.

Applications for the prize are open from August 18 to September 20, 2021. Astellas plans to award up to two prizes, focusing on innovative research in areas such as oncology and neuroscience, aligning with its R&D strategy to enhance drug development for unmet medical needs.

Astellas Pharma announced FDA approval for its supplemental New Drug Application for PROGRAF (tacrolimus), expanding its use to prevent organ rejection in adult and pediatric lung transplant recipients. This marks a significant growth in PROGRAF's indications, now covering liver, kidney, heart, and lung transplants. The approval is based on real-world evidence from a study of over 15,000 adult and 450 pediatric patients, demonstrating one-year graft survival rates of 90.9% and 91.7% respectively. PROGRAF is currently marketed in around 100 countries and has a consistent safety profile.

Astellas Pharma and Seagen announced that the FDA granted regular approval for PADCEV® (enfortumab vedotin-ejfv) for adult patients with locally advanced or metastatic urothelial cancer who are ineligible for cisplatin chemotherapy. This approval follows its accelerated approval in 2019 and is based on data from the Phase 3 EV-301 trial, which demonstrated a median overall survival of 12.9 months for PADCEV versus 9.0 months for chemotherapy. The drug offers an important treatment option for patients with limited therapies and poor prognosis.

Astellas Pharma and FibroGen announced a positive opinion from the European Medicines Agency's CHMP for roxadustat, aimed at treating symptomatic anemia in chronic kidney disease (CKD) patients. This potential approval would make roxadustat the first oral HIF-PH inhibitor in Europe. The CHMP's positive stance is based on a Phase 3 program involving 9,600 patients, demonstrating effectiveness in increasing hemoglobin levels and a safety profile comparable to existing treatments. The European Commission will review the opinion within 67 days for a final decision.

Astellas Pharma presented new data in acute myeloid leukemia (AML) at the European Hematology Association (EHA) virtual congress from June 9-17. Eight Astellas-sponsored abstracts were showcased, including two oral presentations and four posters. The research underscores patient and physician preferences for treatment strategies post-hematopoietic stem cell transplantation and evaluates gilteritinib's efficacy in treating FLT3 mutation-positive AML. The presentation emphasizes Astellas' commitment to advancing AML research with ongoing evaluations of treatment combinations.

Astellas Pharma and Seagen have announced updated results from two clinical trials involving PADCEV® (enfortumab vedotin-ejfv). The EV-201 study showed a 51% objective response rate in patients with advanced urothelial cancer who were ineligible for cisplatin, with a median overall survival of 16.1 months. The EV-103 trial, testing PADCEV with Merck's KEYTRUDA®, reported a 73.3% objective response rate and a median overall survival of 26.1 months. The FDA has granted Priority Review for PADCEV based on these results.

Astellas Pharma will present new oncology data at the 2021 ASCO Annual Meeting from June 4-8, focusing on treatments for hard-to-treat cancers such as bladder and prostate cancers, along with acute myeloid leukemia. The company will showcase 12 abstracts, underlining its commitment to addressing unmet medical needs. Notable presentations will include quality of life results from the EV-301 trial and analyses on racial disparities in prostate cancer treatment. Astellas collaborates with Seagen and Merck on some therapies, illustrating its partnership-driven approach to advancing cancer treatment.