Astellas Pharma - ALPMY STOCK NEWS

Astellas Pharma announced positive results from the Phase 3 GLOW trial of zolbetuximab plus CAPOX for treating locally advanced, unresectable or metastatic gastric cancer. The study demonstrated a 31.3% reduction in the risk of progression or death compared to CAPOX alone, with a median progression-free survival of 8.21 months. Additionally, overall survival improved by 22.9%, achieving a median of 14.39 months. Serious treatment-emergent adverse events were similar in both treatment and placebo groups. The results will be presented at the upcoming ASCO Plenary Series, paving the way for global regulatory submissions based on the GLOW and SPOTLIGHT trials.

Pfizer (NYSE: PFE) and Astellas Pharma have announced positive topline results from the Phase 3 EMBARK trial, evaluating XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) experiencing high-risk biochemical recurrence. The trial met its primary endpoint, demonstrating a significant improvement in metastasis-free survival (MFS) for patients treated with XTANDI plus leuprolide over placebo. Additionally, significant improvements were noted for patients on XTANDI monotherapy. A positive trend in overall survival was also observed and further data analysis is ongoing. Detailed results will be presented at a future medical meeting.

Pfizer and Astellas announced positive topline results from the Phase 3 EMBARK trial for XTANDI (enzalutamide) in men with non-metastatic hormone-sensitive prostate cancer (nmHSPC) at high risk for biochemical recurrence. The trial met its primary endpoint, showing a statistically significant improvement in metastasis-free survival when comparing XTANDI plus leuprolide to placebo plus leuprolide. Additionally, XTANDI monotherapy also demonstrated significant benefits. Preliminary safety analyses revealed no new safety signals. Further details will be presented at future medical meetings, and discussions with the FDA for regulatory submission are anticipated.

Astellas Pharma announced the publication of pivotal Phase 3 SKYLIGHT 1 study results for fezolinetant, a nonhormonal treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, in The Lancet. The study demonstrated statistically significant reductions in VMS frequency and severity at 4 and 12 weeks, with improvements lasting through the 52-week trial. Treatment-emergent adverse events occurred in 37-45% of participants, with common events being headache and COVID-19. Regulatory applications for fezolinetant are under review in multiple regions, and if approved, it could become the first nonhormonal option for treating menopausal VMS.

Astellas Pharma announced positive results from the Phase 3 China ARCHES study of XTANDI^® (enzalutamide) combined with androgen deprivation therapy (ADT) in men with metastatic hormone-sensitive prostate cancer (mHSPC). The study, involving 180 patients, achieved its primary endpoint by significantly delaying prostate-specific antigen (PSA) progression compared to placebo plus ADT. Key secondary endpoints were also met, indicating reduced radiographic progression-free survival (rPFS) and higher rates of undetectable PSA. These findings support XTANDI’s potential as a treatment option, pending regulatory approval from the China National Medical Products Administration (NMPA).

Astellas Pharma and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) announced that the Phase 3 MORPHO trial of gilteritinib did not meet its primary endpoint of relapse-free survival (RFS) in patients with FLT3-ITD mutated acute myeloid leukemia (AML) after allogeneic stem cell transplantation. The study involved 356 patients and was double-blind and placebo-controlled. Despite not achieving significant RFS, Astellas remains committed to advancing treatment options for AML. The results will be analyzed further for additional secondary endpoints. This outcome is not expected to impact the financial forecasts for the fiscal year ending March 31, 2023.

Astellas Pharma has announced preliminary safety and efficacy data from the ongoing FORTIS Phase 1/2 clinical trial of AT845, a gene therapy for adults with late-onset Pompe disease (LOPD). The results were presented at the 19th Annual WORLDSymposium in Orlando, FL. Four participants in the trial received a one-time infusion of AT845, and three have discontinued enzyme replacement therapy (ERT) with stable functional outcomes for up to 51 weeks. AT845 was generally well-tolerated, with mild treatment-emergent adverse effects reported. The FDA lifted a clinical hold in January 2023, allowing the trial to continue.

Astellas Pharma announced that the FDA is extending the PDUFA goal date for its investigational therapy, fezolinetant, by three months to May 22, 2023. This extension is intended to provide the FDA with additional time to complete its review of the drug, which targets moderate to severe vasomotor symptoms caused by menopause. Despite the extension, Astellas remains confident in the drug's clinical profile and potential benefits. The impact on the company's financial results for the current fiscal year, ending March 31, 2023, is expected to be minor. Fezolinetant is still under investigation, and regulatory approval is not guaranteed.

Astellas Pharma, based in Tokyo, has announced a commitment to achieve net zero greenhouse gas emissions by 2050. The company aims to reduce emissions in Scopes 1, 2, and 3 by 90% from 2015 levels and neutralize the remaining 10% emissions. This initiative has been accredited by the Science Based Targets initiative (SBTi) for its 2030 GHG emission reduction targets. CEO Kenji Yasukawa emphasized this commitment as part of their Corporate Strategic Plan, which focuses on sustainability and reducing environmental impact.