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Astellas Pharma Inc. (ALPMF)

9.75

+0.58

(+6.32%)

At close: 10:53 AM EDT

U.S. Stocks Erase Early Gains

U.S. stocks extended recent declines as March retail sales increased more than expected, causing traders scale back bets on Fed rate cuts.

The Wall Street Journal 4 days ago

ALPMF
+6.32%
ALPMY
+0.32%
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 22 days ago

ALPMF
+6.32%
ALPMY
+0.32%
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 24 days ago

ALPMF
+6.32%
ALPMY
+0.32%
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 24 days ago

ALPMF
+6.32%
ALPMY
+0.32%
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 28 days ago

ALPMF
+6.32%
ALPMY
+0.32%
Q4 2023 Taysha Gene Therapies Inc Earnings Call

Q4 2023 Taysha Gene Therapies Inc Earnings Call

Thomson Reuters StreetEvents 30 days ago

TSHA

ALPMY
+0.32%
With new data, Bayer readies rival to Astellas menopause drug

Following a third successful Phase 3 trial, the company is planning approval filings for the medicine, which it acquired in a $425 million deal four years ago.

BioPharma Dive last month

ALPMY
+0.32%
BAYRY
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

Kelonia will receive $40 million upfront through the partnership, and could receive $35 million more if Astellas opts into another program.

BioPharma Dive 2 months ago

ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

PFE

ALPMF
+6.32%
ALPMY
+0.32%
US FDA declines to approve Astellas' gastric cancer drug

Japan's Astellas Pharma said on Monday the U.S. Food and Drug Administration (FDA) has declined to approve its experimental drug to treat a type of gastric cancer, citing issues related to a third-party manufacturer. The FDA has not raised any concerns related to the clinical data, and is not requesting additional clinical studies, Astellas said. The company said it is working closely with the FDA and the third-party manufacturer to quickly resolve the regulator's feedback, adding that the decision does not affect any other Astellas product.

Reuters 3 months ago

ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%
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

ALPMF
+6.32%
ALPMY
+0.32%

Performance Overview

Return	ALPMF	Nikkei 225
YTD	-16.97%	+10.77%
1-Year	-32.89%	+29.58%
3-Year	-27.23%	+24.87%

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Astellas Pharma Inc. (ALPMF)

U.S. Stocks Erase Early Gains

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

Q4 2023 Taysha Gene Therapies Inc Earnings Call

With new data, Bayer readies rival to Astellas menopause drug

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

Astellas teams up with startup Kelonia to make ‘in vivo’ cell therapies

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

US FDA declines to approve Astellas' gastric cancer drug

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

Performance Overview