Astellas Pharma Stock Price, News & Analysis

Astellas Venture Management and MBC BioLabs announced the third iteration of the Future Innovator Prize, aimed at supporting entrepreneurial scientists and biotech startups. The competition offers winners a year of access to MBC BioLabs’ facilities and Astellas’ R&D resources. Interested parties can submit their applications until November 1, 2021. The initiative seeks to accelerate novel therapeutic programs, especially in oncology, immunology, and neuroscience. Previous winners have shown potential in addressing unmet medical needs, reflecting a commitment to innovative science for patient benefit.

Astellas Pharma and Pfizer announced that XTANDI (enzalutamide) improved overall survival in the Phase 3 ARCHES trial for men with metastatic hormone-sensitive prostate cancer (mHSPC). The study involved 1,150 patients and showed a 34% reduction in the risk of death (HR=0.66; p<0.0001) compared to placebo. Median OS was not reached in either group. Results are set to be presented at the ESMO Congress. This marks the third stage where enzalutamide has shown survival benefits in advanced prostate cancer, enhancing its clinical profile in earlier disease settings.

Astellas Pharma has reported a serious adverse event in the ASPIRO clinical trial for AT132, aimed at treating X-linked Myotubular Myopathy. A participant, who had developed this adverse event, tragically passed away on September 9, 2021. This incident has prompted Astellas to pause screening and dosing in the trial, which had resumed after a previous FDA clinical hold. The FDA has placed the ASPIRO trial on hold again, pending further review. Astellas remains committed to investigating the findings and continuing the development of AT132.

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.