Astellas Pharma Inc

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Astellas Pharma, Inc. engages in the research, development, manufacture, import, and export of pharmaceutical products. Its products focus on therapeutic fields that include transplantation, immunology, infectious diseases, urology, oncology, neuroscience, diabetic complications, and metabolic diseases. The firm's global brands include Prograf, Vesicare, Protopic, Harnal, and Funguard. The company was founded by Kenji Yamanouchi in April 1923 and is headquartered in Tokyo, Japan.

SAN FRANCISCO , Nov. 20, 2024 /PRNewswire/ -- Astellas Pharma U.S., Inc. (President: Mike Petroutsas, "Astellas") today announced that it has entered into an agreement with Desert Oasis Healthcare (DOHC), a member of Heritage Provider Network, to pilot DIGITIVA™, a non-invasive digital health solution for the management of heart failure patients. In the next few weeks, eligible patients receiving care with DOHC will begin using DIGITIVA as a new method for managing their heart health while working in partnership with their healthcare team.

Astellas Announces Desert Oasis Healthcare as First Health System to Implement DIGITIVA™ for Heart Failure Management

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Should Value Investors Buy Astellas Pharma (ALPMY) Stock?

Astellas: Can The Gastric Cancer Approval Be The Inflection Point?

VYLOY is the first and only CLDN18.2-targeted treatment approved in the U.S. for adults with advanced gastric and gastroesophageal junction cancer whose tumors are CLDN18.2 positive TOKYO , Oct. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has approved VYLOY™ (zolbetuximab-clzb) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive as determined by an FDA-approved test.1 VYLOY is the first and only CLDN18.2-targeted therapy approved in the U.S. In the SPOTLIGHT and GLOW clinical trials, approximately 38% of patients screened had tumors that were CLDN18.2 positive.2,3 CLDN18.2 positivity is defined as ≥75% of tumor cells demonstrating moderate to strong membranous CLDN18 immunohistochemical staining, as determined by the VENTANA® CLDN18 (43-14A) RxDx Assay from Roche.2,3 Astellas collaborated with Roche on the newly approved immunohistochemistry (IHC) companion diagnostic (CDx) test to identify patients who may be eligible for VYLOY.4 Moitreyee Chatterjee-Kishore, Ph.D., M.B.A., Senior Vice President and Head of Immuno-Oncology Development, Astellas "The approval of VYLOY as the first and only targeted therapy for CLDN18.2-positive patients in the U.S. further delivers on our relentless pursuit of scientific progress for devastating diseases like gastric and GEJ cancers, which are often only discovered at the advanced stage.

Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

The U.S. Food and Drug Administration approved Astellas' gastric cancer therapy, the health regulator's website showed on Friday.

FDA approves Astellas' gastric cancer therapy

TOKYO , Oct. 10, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") 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. VMS, also known as hot flashes and/or night sweats, are common symptoms of menopause.

Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause

Astellas receives an exclusive option to license AVB-101, an investigational, AAV-based gene therapy in Phase 1/2 development  AviadoBio receives $20 million equity investment, up to $30 million in upfront payments and is eligible to receive up to $2.18 billion in license fees and milestone payments plus royalties if Astellas exercises its option LONDON and TOKYO , Oct. 8, 2024 /PRNewswire/ -- AviadoBio Ltd. ("AviadoBio") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today 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).

Astellas and AviadoBio Announce Exclusive Option and License Agreement for Gene Therapy AVB-101 Targeting Frontotemporal Dementia and Other Indications

Are Investors Undervaluing Astellas Pharma (ALPMY) Right Now?

SAN DIEGO--(BUSINESS WIRE)--Singlera Genomics and Astellas Pharma presented results during the JSOT 2024 Annual Meeting demonstrating that drug-induced testicular toxicity can be detected using cell-free DNA methylation in animal models. Singlera's mTitan technology has previously been utilized to non-invasively detect cancer methylation signals in blood four years prior to patients showing symptoms. Astellas presented the results of animal model experiments demonstrating that these technologie.

Singlera Genomics and Astellas Present Methylation-based Organ Toxicity Detection at 2024 JSOT Annual Meeting

- Zolbetuximab is currently 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 cancer1,2 - Treatment with the claudin 18.2-targeted monoclonal antibody shown to significantly extend both progression-free survival and overall survival in Phase 3 trials1, 2 TOKYO , Sept. 20, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission (EC) has approved VYLOY™ (zolbetuximab) in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are claudin (CLDN) 18.2 positive.

Astellas Receives Approval from the European Commission for VYLOY™ (zolbetuximab) in Combination with Chemotherapy for Advanced Gastric and Gastroesophageal Junction Cancer

- New digital health solution for heart failure management puts patients at the center of their care by providing ability for at-home disease monitoring - TOKYO , Sept. 18, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that DIGITIVA™, a non-invasive digital health solution for heart failure management, has been listed with the U.S. Food and Drug Administration (FDA).

Astellas Announces FDA Listing of DIGITIVA™ for the Management of Heart Failure

- Eight abstracts, including two oral presentations, feature new clinical data from Astellas' oncology portfolio and two lead pipeline programs across a broad range of cancer types - TOKYO , Sept. 11, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") will highlight new data from across its approved and investigational cancer therapies during the 2024 European Society for Medical Oncology (ESMO) Congress being held in Barcelona, Spain on 13-17 September.

Astellas Presents Scientific Progress in Advanced and Hard-to-Treat Cancers at ESMO 2024

The Astellas Life Sciences Center hosts the company's first U.S.-based open innovation SakuLab™ incubator space dedicated to fostering pioneering science through collaboration with external partners TOKYO and CAMBRIDGE, Mass. , Sept. 5, 2024 /PRNewswire/ -- Today, Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") officially opened its new Astellas Life Sciences Center (ALSC) in Cambridge, Mass.

Astellas Unveils New Life Sciences Center in Cambridge, Massachusetts to Accelerate the Discovery of Breakthrough Therapies

- Pooled analyses from two SKYLIGHT™ studies highlight impact on sleep disturbance and impairment, relationship between improvements in the frequency or severity of hot flashes and mood - Pooled data from three SKYLIGHT™ studies assess safety and tolerability in Hispanic/Latina women - Responder analysis from DAYLIGHT™study evaluates reduction in VMS frequency in women unwilling or unable to take hormone therapy TOKYO , Sept. 4, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced that VEOZAH™ (fezolinetant), its first-in-class treatment for moderate to severe vasomotor symptoms (VMS) due to menopause, will be featured in four oral presentations during the 2024 Annual Meeting of The Menopause Society (TMS) September 10-14 in Chicago.

Astellas to Present VEOZAH™ (fezolinetant) Data at 2024 Annual Meeting of The Menopause Society

- First regimen approved in advanced urothelial cancer to demonstrate superiority to platinum-containing chemotherapy, the standard of care for nearly 40 years1 - European Marketing Authorization based on positive overall survival and progression-free survival results from the global Phase 3 EV-302 trial1 TOKYO , Aug. 28, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the European Commission has granted Marketing Authorization for PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy. The approval is based on results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) which showed that enfortumab vedotin in combination with pembrolizumab nearly doubled median overall survival (OS) and significantly extended progression-free survival (PFS) compared to platinum-containing chemotherapy.

European Commission Approves Astellas' PADCEV™ (enfortumab vedotin) in Combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Urothelial Cancer

- HIGHLIGHT 1™ study to evaluate fezolinetant for treatment of moderate to severe vasomotor symptoms in women with stage 0-3 hormone receptor positive breast cancer receiving adjuvant endocrine therapy - TOKYO , Aug. 27, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced dosing of the first patient in the HIGHLIGHT 1™ Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) in women with breast cancer receiving adjuvant endocrine therapy. Breast cancer is the most common cancer in women globally, with approximately 2.3 million new cases in 2022.1 Hot flashes and night sweats, also known as VMS, are recognized as the most prominent side effect of adjuvant endocrine therapies used in the treatment of breast cancer.

Astellas Initiates Phase 3 Clinical Study of Fezolinetant for VMS in Women with Breast Cancer Receiving Adjuvant Endocrine Therapy

Chinese authorities have indicted a Japanese employee of Astellas Pharma Inc , who had been detained in China since March 2023 on suspicion of espionage, the Japanese pharmaceutical company said on Wednesday.

Japan's Astellas says employee indicted by China's prosecutors

Britain's health regulator said on Wednesday it has approved Astellas Pharma's drug to treat a type of gastric cancer.

UK regulator approves Astellas' gastric cancer drug

Astellas Pharma Inc. (OTCPK:ALPMF) Q1 2024 Earnings Conference Call August 1, 2024 3:00 AM ET Company Participants Hiromitsu Ikeda - Chief Communications and IRO Tadaaki Taniguchi - CMO Claus Zieler - CCO Atsushi Kitamura - CFO Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Seiji Wakao - JPMorgan Securities Akinori Ueda - Goldman Sachs Securities Kasumi Haruta - UBS Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Hyogo - Mitsubishi UFJ Trust and Banking Corporation Miki Sogi - Sanford C. Bernstein Tony Ren - Macquarie Capital Operator Hiromitsu Ikeda Everyone, thank you so much for your participation in this Financial Results ended June 30th Financial Call.

Astellas Pharma Inc. (ALPMF) Q1 2024 Earnings Call Transcript

-       If approved by the European Commission, zolbetuximab would become the first and only CLDN18.2-targeted therapy approved in the European Union  -       A decision on the EU marketing authorization is expected by October 2024 TOKYO , July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on July 26, 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending the approval of zolbetuximab in the European Union. Zolbetuximab, a first-in-class claudin (CLDN) 18.2-targeted monoclonal antibody, is recommended in combination with fluoropyrimidine- and platinum-containing chemotherapy for the first-line treatment of adult patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive.1 If approved, zolbetuximab would become the first and only CLDN18.2-targeted therapy available for patients in the European Union.

Astellas Receives Positive CHMP Opinion for Zolbetuximab in Combination with Chemotherapy for Treatment of Advanced Gastric and Gastroesophageal Junction Cancer

- If approved, enfortumab vedotin  in combination with pembrolizumab  will be the first and only treatment to offer an alternative to platinum-containing chemotherapy, the current standard of care for those with unresectable or metastatic urothelial cancer - Positive opinion is based on Phase 3 EV-302 clinical trial results which showed enfortumab vedotin  in combination with pembrolizumab nearly doubled median overall survival compared to platinum-containing chemotherapy1 TOKYO , July 26, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending approval of PADCEV™ (enfortumab vedotin, an antibody-drug conjugate [ADC]) in combination with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the first-line treatment of adult patients with unresectable or metastatic urothelial cancer, who are eligible for platinum-containing chemotherapy.2 Ahsan Arozullah, MD, MPH, Senior Vice President and Head of Oncology Development, Astellas  " Treatment options available to patients with unresectable or metastatic urothelial cancer are currently limited mainly to platinum-containing chemotherapy. The data underpinning the CHMP's approval recommendation show that this combination could change how clinicians manage first-line treatment of this disease.

Astellas Receives Positive CHMP Opinion for PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

- Collaborative Research on Innovative Cartilage Organoid Cell Therapy for Intervertebral Disc Degenerative Disease using Astellas' Universal Donor Cell Technology - TOKYO and OSAKA, Japan , July 22, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Graduate School of Medicine / Faculty of Medicine, Osaka University (President: Shojiro Nishio "Osaka University") today announced that Astellas Institute for Regenerative Medicine (a wholly owned subsidiary of Astellas, "AIRM"), Universal Cells (a wholly owned subsidiary of Astellas) and Osaka University have entered into a research collaboration to develop innovative pluripotent stem cell*1-derived cartilage organoid cell therapy for the treatment of intervertebral disc degenerative disease*2. Universal Cells holds the rights to Universal Donor Cell (UDC) technology to create cell therapy products from pluripotent stem cells that have reduced risk of immune rejection by genetically modifying Human Leukocyte Antigen (HLA) using gene editing technology.

Astellas and Graduate School of Medicine / Faculty of Medicine, Osaka University Enter into Research Collaboration to Develop Pluripotent Stem Cell-Derived Cartilage Organoid Cell Therapy

If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S. TOKYO , May 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class investigational claudin (CLDN) 18.2-targeted monoclonal antibody, for the first-line treatment of adults with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are CLDN18.2 positive. If approved, zolbetuximab would be the first CLDN18.2-targeted therapy approved for this patient population in the U.S. Under the Prescription Drug User Fee Act (PDUFA), the FDA has set a new target action date of November 9, 2024.

U.S. FDA ACKNOWLEDGES ASTELLAS' RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE

- Focuses on digitizing cell manufacturing processes through robotics technology TOKYO , May 21, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that it signed a memorandum of understanding with YASKAWA Electric Corporation (YASKAWA) to begin discussions on the creation of an innovative cell therapy ecosystem through the integration of pharmaceutical and robotics technologies. This memorandum is legally non-binding and will lead to further specific discussions between the two companies in the future.

Astellas Announces a Collaboration with YASKAWA to Create an Innovative Cell Therapy Ecosystem through the Integration of Pharmaceutical and Robotics Technologies

- 154,000 square-foot lab and office facility creates a central location for Astellas' West Coast cell and gene therapy research and business development operations  TOKYO and SAN FRANCISCO , May 8, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the opening of a new $90 million, state-of-the-art center at 480 Forbes Boulevard in South San Francisco, CA. The newly built 154,000-square-foot lab and office facility expands the company's commitment to South San Francisco's biotech ecosystem and creates a central location for its West Coast employees across Research, Technical Operations, Medical and Development and Commercial, previously located in multiple locations throughout the Bay Area.

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