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At close: April 25 at 8:11 AM GMT+2

Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the European Commission (EC) has approved a label extension for XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy (ADT) for the treatment of adult men with high-risk biochemical recurrent (BCR) non-metastatic hormone-sensitive prostate cancer (nmHSPC) who are unsuitable for salvage-radiotherapy.

PR Newswire 2 days ago
Takeda, Astellas and Sumitomo Mitsui Banking Announce Master Agreement to Establish Joint Venture Company for Incubation of Early Drug Discovery Programs

Takeda Pharmaceutical Company Limited (TSE: 4502/NYSE: TAK, President and CEO; Christophe Weber, "Takeda"), Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), and Sumitomo Mitsui Banking Corporation (President & CEO: Akihiro Fukutome, "SMBC") today announced that the three companies signed a master agreement on April 22, 2024, to establish a joint venture company. The new company will be dedicated to the incubation*1 of early drug discovery programs, primarily origin

PR Newswire 3 days ago
China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 27, 2024 the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has accepted the supplemental Biologics License Application (sBLA) for enfortumab vedotin with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If appr

PR Newswire 28 days ago
Astellas Receives Permanent J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

Iveric Bio, An Astellas Company (TSE: 4503, President and CEO: Naoki Okamura, "Astellas"), today announced the U.S. Centers for Medicare and Medicaid Services (CMS) has assigned a unique, permanent Healthcare Common Procedure Coding System (HCPS) J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD). The new J-code, J2782, is effective April 1, 2024.

PR Newswire 30 days ago
Astellas' VYLOY™ (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that on March 26, 2024, Japan's Ministry of Health, Labour and Welfare (MHLW) approved VYLOY™ (zolbetuximab), an anti-claudin 18.2 (CLDN18.2) monoclonal antibody for patients with CLDN18.2 positive, unresectable, advanced or recurrent gastric cancer. VYLOY is the first and only CLDN18.2-targeted therapy approved by any regulatory agency in the world.

PR Newswire 30 days ago
Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive opinion recommending approval of XTANDI™ (enzalutamide) as monotherapy or in combination with androgen deprivation therapy for the treatment of adult men with high risk biochemical recurrent (BCR) non-metastatic hormone sensitive prostate cancer (nmHSPC) who are unsuitable for salvage rad

PR Newswire last month
FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA® (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children

Astellas Pharma US, Inc. (TSE: 4503, President: Mark Reisenauer, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has granted orphan drug and pediatric exclusivity to CRESEMBA® (isavuconazonium sulfate) for the treatment of invasive aspergillosis (IA) and invasive mucormycosis (IM) in pediatric patients. On December 8, 2023, CRESEMBA for injection was approved for pediatric patients 1 year of age and older and capsules for pediatric patients 6 years of age and older w

PR Newswire last month
Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced dosing of the first patient in the STARLIGHT™ 2 Phase 3 pivotal study for fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of vasomotor symptoms (VMS) associated with menopause in Japanese women.

PR Newswire last month
PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has granted priority review for the company's Supplemental New Drug Application (sNDA) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial canc

PR Newswire 2 months ago
Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Kelonia Therapeutics (CEO, Founder: Kevin Friedman, Ph.D., "Kelonia") today announced that Xyphos Biosciences, Inc., (a wholly owned subsidiary of Astellas, "Xyphos") and Kelonia have entered into a research collaboration and license agreement to develop novel Immuno-Oncology therapeutics.

PR Newswire 2 months ago
Astellas Makes Announcement about Management Structure

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the following changes to its management structure effective April 1, 2024.

PR Newswire 2 months ago
Astellas to Air New VEOZAH® (fezolinetant) TV Spot During the Super Bowl

Astellas Pharma US, Inc. (President: Mark Reisenauer, "Astellas") today announced that it will air a new version of its commercial for VEOZAH® (fezolinetant) just before Super Bowl kickoff on Sunday, February 11, 2024. VEOZAH is a nonhormonal treatment option approved by the U.S. Food and Drug Administration (FDA) to reduce the frequency and severity of moderate to severe vasomotor symptoms (VMS), also known as hot flashes and night sweats, due to menopause.1,2 The "Fewer Hot Flashes, More Not F

PR Newswire 2 months ago
Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced the submission of a Supplemental New Drug Application (sNDA) on January 31 to Japan's Ministry of Health, Labour and Welfare (MHLW) for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). I

PR Newswire 2 months ago
Astellas Announces Strategic Collaboration with Mass General Brigham

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that it has entered into a strategic collaboration with Mass General Brigham (President and CEO: Anne Klibanski, MD) that is focused on translational medicine and early development to establish an integrated approach to scientific advancement and clinical expertise.

PR Newswire 2 months ago
European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

NEW YORK & TOKYO, January 26, 2024--Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that on January 26 the European Medicines Agency (EMA) validated for review a Type II variation application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) as a combination therapy for the first-line treatment of adult patients with previously untreated locally advanced or metastatic urothelial cancer (la/mUC). If approved,

Business Wire 2 months ago
Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) issued a complete response letter on January 4, 2024, regarding the Biologics License Application (BLA) for zolbetuximab, an investigational agent for the treatment of patients with locally advanced unresectable or metastatic human epidermal growth factor receptor 2 (HER2)-negative gastric or gastroesophageal junction (GEJ) adenocarcinoma whose tumors are cla

PR Newswire 3 months ago
Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Elpiscience Biopharma, Ltd. (Chairman and CEO: Darren Ji, MD, Ph.D., "Elpiscience") and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced a research collaboration and license agreement for novel bi-specific macrophage engagers, ES019 and another program. The two companies will collaboratively conduct early-stage research for these two programs. Elpiscience will also grant Astellas the right to add up to two additional programs to be included in the co

PR Newswire 3 months ago
Astellas Completes Acquisition of Propella Therapeutics

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that it has completed the acquisition of Propella Therapeutics, Inc. (President and CEO: William Moore, "Propella"), and has become a wholly owned subsidiary of Astellas as of U.S. Eastern Time December 21, 2023.

PR Newswire 4 months ago
EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") contributed to the development of a pediatric formulation to treat schistosomiasis as a member of the Pediatric Praziquantel Consortium (Consortium). The Consortium announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a positive scientific opinion for arpraziquantel to treat one of the neglected tropical diseases, schistosomiasis, in preschool-aged chi

PR Newswire 4 months ago
PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") and Pfizer Inc. (NYSE: PFE) today announced that on December 15, 2023 the U.S. Food and Drug Administration (FDA) has approved PADCEV® (enfortumab vedotin-ejfv, an antibody-drug conjugate [ADC]) with KEYTRUDA® (pembrolizumab, a PD-1 inhibitor) for the treatment of adult patients with locally advanced or metastatic urothelial cancer (la/mUC). This combination is the first approved to offer an alternative to platinum-con

PR Newswire 4 months ago

Performance Overview

Return	YPH.MU	Nikkei 225
YTD	-134.19%	+13.68%
1-Year	-82.79%	+33.87%
3-Year	-75.81%	+30.61%

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AFN/USD (YPH.MU)

Astellas' XTANDI™ (Enzalutamide) Granted European Commission Approval for Use in Additional Recurrent Early Prostate Cancer Treatment Setting

Takeda, Astellas and Sumitomo Mitsui Banking Announce Master Agreement to Establish Joint Venture Company for Incubation of Early Drug Discovery Programs

China's National Medical Products Administration Accepts Astellas and Pfizer's Supplemental Biologics License Application for enfortumab vedotin with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Astellas Receives Permanent J-code for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

Astellas' VYLOY™ (zolbetuximab) Approved in Japan for Treatment of Gastric Cancer

Astellas Receives Positive CHMP Opinion for XTANDI™ in Additional Recurrent Early Prostate Cancer Treatment Setting

FDA Grants Orphan Drug and Pediatric Exclusivities for CRESEMBA® (isavuconazonium sulfate) for Invasive Aspergillosis and Invasive Mucormycosis in Children

Astellas Initiates Phase 3 Clinical Studies of Fezolinetant for VMS Associated with Menopause in Japan

PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) Granted Priority Review by Japan's Ministry of Health, Labour and Welfare for First-Line Treatment of Advanced Bladder Cancer

Astellas and Kelonia Therapeutics Enter into Research and License Agreement to Develop Novel Immuno-Oncology Therapeutics

Astellas Makes Announcement about Management Structure

Astellas to Air New VEOZAH® (fezolinetant) TV Spot During the Super Bowl

Astellas Submits Supplemental New Drug Application in Japan for PADCEV™ (enfortumab vedotin (genetical recombination)) with KEYTRUDA® (pembrolizumab (genetical recombination)) for First-Line Treatment of Advanced Bladder Cancer

Astellas Announces Strategic Collaboration with Mass General Brigham

European Medicines Agency Validates Type II Variation Application for PADCEV® (enfortumab vedotin) with KEYTRUDA® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

Astellas Provides Update on Zolbetuximab Biologics License Application in U.S.

Elpiscience and Astellas Enter into Research Collaboration and License Agreement for Novel Bispecific Macrophage Engager

Astellas Completes Acquisition of Propella Therapeutics

EMA Recommends Arpraziquantel for Treatment of Schistosomiasis in Preschool-Aged Children

PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) Approved by FDA as the First and Only ADC Plus PD-1 to Treat Advanced Bladder Cancer

Performance Overview