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ASTELLAS PHARMA UNSP/ADR - ALPMY STOCK NEWS

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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 US has launched 'Cooler Moments' in partnership with Dr. Jen Ashton to address menopausal hot flashes and empower women's health advocacy. The initiative focuses on educating women about moderate to severe vasomotor symptoms (VMS) and available treatment options.

The campaign features Dr. Ashton hosting a video series to debunk menopause myths and discuss VEOZAH, a first-of-its-kind, FDA-approved, hormone-free treatment for reducing moderate to severe hot flashes and night sweats due to menopause. The program includes personal testimonials and aims to encourage open dialogue between women and healthcare providers about menopause management.

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Astellas Pharma US has partnered with Desert Oasis Healthcare (DOHC) to pilot DIGITIVA™, a non-invasive digital health solution for heart failure management. DIGITIVA combines the CORE 500™ Digital Stethoscope with a smartphone app featuring AI-driven coaching and educational resources. The system provides clinicians with patient reports highlighting cardioacoustic biomarkers and physiological parameters to enable earlier intervention. The partnership will evaluate DIGITIVA's effectiveness through clinical measures, cost metrics, and patient quality of life assessments using the Kansas City Cardiomyopathy Questionnaire. DIGITIVA received FDA listing in September 2024.

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Astellas Pharma Inc. announced FDA approval of VYLOY™ (zolbetuximab-clzb) for first-line treatment of advanced gastric and gastroesophageal junction (GEJ) cancer in adults with CLDN18.2-positive tumors. VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S.

The approval is based on results from the Phase 3 SPOTLIGHT and GLOW clinical trials, which met primary endpoints of progression-free survival and overall survival. Approximately 38% of patients screened had CLDN18.2-positive tumors. An FDA-approved companion diagnostic test from Roche is used to identify eligible patients.

VYLOY is now approved in five markets worldwide, including Japan, the UK, EU, South Korea, and the U.S. Astellas has reflected the impact of this approval in its financial forecast for the fiscal year ending March 31, 2025.

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iota Biosciences, a subsidiary of Astellas Pharma, has received FDA approval for an Investigational Device Exemption (IDE) to conduct an Early Feasibility Study (EFS) on a novel implantable bladder device. The device aims to treat underactive bladder (UAB) by delivering electrical stimulation to induce bladder contractions. The FDA granted a staged approval, initially allowing enrollment of three participants, with potential expansion to 10 participants upon successful safety outcomes.

UAB affects up to 28% of men over 50 and 45% of older women with lower urinary tract symptoms. The condition impacts millions worldwide, with current treatment options. This innovative approach could provide an alternative to clean intermittent catheterization, which can be burdensome and risky. The study marks a significant step in Astellas' commitment to expanding treatment options beyond traditional pharmaceuticals through bioelectronic technologies.

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Astellas Pharma Inc. announced that VEOZA™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) associated with menopause, will be featured in four oral and two poster presentations during the International Menopause Society (IMS) 19th World Congress on Menopause in Melbourne, Australia, October 19-22.

The presentations will cover a range of topics, including:

  • Patient-reported sleep outcomes and impact on work productivity from the SKYLIGHT 1 and 2 studies
  • Response and quality of life in women treated with fezolinetant who are unsuitable for hormone therapy from the DAYLIGHT study
  • Analyses showing no association between fezolinetant treatment and incidence of malignant neoplasm
  • Study design for the HIGHLIGHT 1 phase 3 clinical study evaluating fezolinetant for VMS in breast cancer patients

The data presented aims to expand knowledge about fezolinetant beyond pivotal trials, highlighting its safety, efficacy, and positive impact on patient-reported outcomes.

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AviadoBio and Astellas Pharma have announced an exclusive option and license agreement for AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development for patients with frontotemporal dementia with progranulin mutations (FTD-GRN). Under the agreement, Astellas will have the option to receive worldwide exclusive license for development and commercialization rights to AVB-101 in FTD-GRN and other potential indications.

Astellas will make a $20 million equity investment and up to $30 million in upfront payments for the option to license AVB-101. AviadoBio is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option. The collaboration aims to address the unmet need in frontotemporal dementia, combining AviadoBio's gene therapy candidate and delivery expertise with Astellas' global capabilities in development and commercialization of gene therapies.

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Astellas Pharma Inc. announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved PADCEV™ (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with radically unresectable urothelial carcinoma. This approval is based on the EV-302 clinical trial, which showed significant improvements in overall survival and progression-free survival compared to platinum-containing chemotherapy.

Key findings from the EV-302 trial include:

  • Median overall survival: 31.5 months for the combination therapy vs. 16.1 months for chemotherapy
  • 53% reduction in risk of death
  • Median progression-free survival: 12.5 months for the combination therapy vs. 6.3 months for chemotherapy
  • 55% reduction in risk of cancer progression or death

This approval offers an alternative to platinum-containing chemotherapy, the current standard of care for first-line treatment of radically unresectable urothelial cancer in Japan.

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Astellas Pharma Inc. announced that the European Commission has approved VYLOY™ (zolbetuximab) in combination with chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic HER2-negative gastric or gastroesophageal junction adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive. Zolbetuximab is the first and only therapy approved in the European Union to target claudin 18.2, a biomarker positively expressed by 38% of patients with advanced gastric cancer.

Phase 3 clinical trials showed that treatment with zolbetuximab provided statistically significant improvements in progression-free survival (PFS) and overall survival (OS) compared to standard of care chemotherapies. The European Marketing Authorization is valid in all 27 EU member states, Iceland, Liechtenstein, and Norway. This approval follows recent approvals in the UK and Japan, with further applications submitted to other regulatory agencies worldwide.

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Astellas Pharma Inc. (TSE: 4503) has announced the FDA listing of DIGITIVA™, a non-invasive digital health solution for heart failure management. This Class I Software as a Medical Device (SaMD) is exempt from 510(k) premarket submission and marks Astellas' first digital health offering in the U.S. DIGITIVA comprises three components: the CORE 500™ Digital Stethoscope by Eko Health Inc., a smartphone app built on Welldoc, Inc.'s platform with American Heart Association content, and a dedicated clinical review team.

DIGITIVA aims to place patients at the center of their care, allowing for at-home disease monitoring and facilitating physician intervention when needed. The solution targets the growing heart failure prevalence in the U.S., expected to reach 8.5 million by 2030. Astellas has incorporated the impact of this FDA listing into its financial forecast for the fiscal year ending March 31, 2025.

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Astellas Pharma Inc. (TSE: 4503) will present eight abstracts at the 2024 European Society for Medical Oncology (ESMO) Congress in Barcelona, showcasing data from its oncology portfolio and pipeline. Key highlights include:

1. EV-302 study results on enfortumab vedotin with pembrolizumab for first-line treatment of urothelial cancer.

2. Five-year follow-up data from the EV-103 DE/A study on enfortumab vedotin with pembrolizumab in first-line cis-ineligible urothelial cancer.

3. Final pooled overall survival data from SPOTLIGHT and GLOW trials on zolbetuximab plus chemotherapy for gastric/GEJ adenocarcinoma.

4. EMBARK post-hoc analyses on enzalutamide for non-metastatic hormone-sensitive prostate cancer.

5. Phase 1 data on ASP3082, a KRAS G12D protein degrader, and ASP1570, a novel DGKζ inhibitor.

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FAQ

What is the current stock price of ASTELLAS PHARMA UNSP/ADR (ALPMY)?

The current stock price of ASTELLAS PHARMA UNSP/ADR (ALPMY) is $9.79 as of December 20, 2024.

What is the market cap of ASTELLAS PHARMA UNSP/ADR (ALPMY)?

The market cap of ASTELLAS PHARMA UNSP/ADR (ALPMY) is approximately 18.8B.

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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