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Astellas Pharma Inc (YPH.SG)

9.25

-0.08

(-0.84%)

At close: January 10 at 8:11:18 AM GMT+1

U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced the U.S. Food and Drug Administration (FDA) accepted the revised supplemental New Drug Application (sNDA) for IZERVAY™ (avacincaptad pegol intravitreal solution) for the treatment of geographic atrophy (GA) secondary to age-related macular degeneration (AMD) on January 6, 2025, in response to the Agency's November 2024 Complete Response Letter (CRL). The application was refiled following a December 20,

PR Newswire 3 days ago

ALPMF
+0.52%
ALPMY
-0.73%
China's National Medical Products Administration (NMPA) Approves PADCEV™ in combination with KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Bladder Cancer

Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, "Astellas") today announced that China's National Medical Products Administration (NMPA) has approved PADCEV™ (enfortumab vedotin) in combination with KEYTRUDA® (pembrolizumab) for adult patients with locally advanced or metastatic urothelial cancer (la/mUC). The treatment combination will provide a new therapeutic option to patients with la/mUC in China and offer an alternative to platinum-containing chemotherapy, the standard of

PR Newswire 4 days ago

ALPMF
+0.52%
ALPMY
-0.73%
Astellas and Sangamo sign capsid deal for neurological diseases

Sangamo will obtain an upfront licence fee of $20m from Astellas.

Pharmaceutical Technology 23 days ago

ALPMY
-0.73%
SGMO
Astellas and Sangamo Therapeutics Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") and Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced they have entered into a license agreement allowing Astellas to leverage Sangamo's novel proprietary neurotropic adeno-associated virus (AAV) capsid, STAC-BBB, which has demonstrated potent blood-brain barrier penetration and neuronal transduction in nonhuman primates. The agreement grants Astellas a worldwide exclusive license

PR Newswire 24 days ago

SGMO

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ALPMY
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Sangamo Therapeutics and Astellas Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

RICHMOND, Calif. & TOKYO, December 19, 2024--Sangamo Therapeutics and Astellas Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

Business Wire 24 days ago

ALPMF
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SGMO
Astellas and Dr. Jen Ashton launch "Cooler Moments" to Spotlight Menopausal Hot Flashes and Empower Women to Advocate for Themselves

Astellas Pharma US, Inc. (TSE: 4503, Head of US Commercial: Michael Petroutsas, "Astellas") today announced the launch of Cooler Moments in partnership with Dr. Jen Ashton, a leading women's health medical expert, Founder and President of Ajenda, and former network news Chief Medical Correspondent who is board-certified in OBGYN and Obesity Medicine. Cooler Moments is an effort to inform and empower women to speak up about their moderate to severe menopausal hot flashes and night sweats, also kn

PR Newswire last month

ALPMF
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How Astellas juggles the moving parts of cancer precision medicine development

While developing its first-in-class gastric cancer drug Vyloy, Astellas had to coordinate with another pharma giant to usher the precision med into the market.

Pharma Voice last month

ALPMY
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Astellas and DOHC partner to pilot digital solution for heart failure management

The solution offers clinicians detailed patient reports, which feature important cardio acoustic biomarkers.

Medical Device Network last month

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

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.

PR Newswire last month

ALPMF
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ALPMY
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FDA issues CRL to Astellas’ IZERVAY sNDA for geographic atrophy

The FDA's feedback centres on statistical aspects concerning the proposed labelling language.

Pharmaceutical Technology last month

ALPMY
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Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

The agency turned back Astellas’ attempt to update its drug Izervay’s labeling. Elsewhere, former NCI director Ned Sharpless founded a new startup and Novartis licensed another radiopharma drug.

BioPharma Dive last month

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NVS

ALPMY
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From Mr. Mucus to the Super Bowl, pharma tries offbeat marketing strategies

As the industry’s marketing dollars shift, companies are targeting potential patients in unique ways.

Pharma Voice last month

ALPMY
-0.73%
Should Value Investors Buy Astellas Pharma (ALPMY) Stock?

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.

Zacks last month

ALPMY
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Astellas withdraws Europe ACP application for AMD treatment

Astellas chose to withdraw its application after discussions with the EMA’s Committee for Medicinal Products for Human Use.

Pharmaceutical Technology 2 months ago

ALPMY
-0.73%
FDA approves Astellas’ VYLOY for gastric cancer treatment

The FDA's decision is grounded in the outcomes of the Phase III SPOTLIGHT and GLOW clinical trials.

Pharmaceutical Technology 2 months ago

ALPMY
-0.73%
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer

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 p

PR Newswire 2 months ago

ALPMF
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ALPMY
-0.73%
Astella’s iota receives FDA go-ahead for bladder implant trial

Iota Biosciences's early feasibility study will test the device in patients with underactive bladder.

Clinical Trials Arena 2 months ago

ALPMY
-0.73%
GLDAF
FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device

iota Biosciences, Inc., a wholly-owned subsidiary of Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") announced today that the U.S. Food and Drug Administration (FDA) has approved its Investigational Device Exemption (IDE) for an Early Feasibility Study (EFS). The EFS will evaluate the safety and feasibility of an investigational implantable device designed to deliver electrical stimulation directly to the bladder wall, inducing contractions that facilitate bladder

PR Newswire 3 months ago

ALPMF
+0.52%
ALPMY
-0.73%
Astellas to Present VEOZA™ (fezolinetant) Data at IMS World Congress on Menopause

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.1,2

PR Newswire 3 months ago

ALPMF
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ALPMY
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Protein prediction wins chemistry Nobel; Alnylam submits an all-important drug application

AlphaFold’s developers were awarded science’s top prize. Elsewhere, J&J is shuttering an intriguing cancer study and Alnylam is asking for approval of a drug that could rival a Pfizer blockbuster.

BioPharma Dive 3 months ago

ALNY

JNJ

ALPMY
-0.73%

Performance Overview

Return	YPH.SG	Nikkei 225
YTD	0.00%	-1.77%
1-Year	-86.06%	+13.79%
3-Year	-94.04%	+37.61%

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Astellas Pharma Inc (YPH.SG)

U.S. FDA Confirms Class 1 Resubmission of the Supplemental New Drug Application for IZERVAY™ (avacincaptad pegol intravitreal solution) for Geographic Atrophy

China's National Medical Products Administration (NMPA) Approves PADCEV™ in combination with KEYTRUDA® (pembrolizumab) for the Treatment of Advanced Bladder Cancer

Astellas and Sangamo sign capsid deal for neurological diseases

Astellas and Sangamo Therapeutics Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

Sangamo Therapeutics and Astellas Announce Capsid License Agreement to Deliver Genomic Medicines for Neurological Diseases

Astellas and Dr. Jen Ashton launch "Cooler Moments" to Spotlight Menopausal Hot Flashes and Empower Women to Advocate for Themselves

How Astellas juggles the moving parts of cancer precision medicine development

Astellas and DOHC partner to pilot digital solution for heart failure management

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

FDA issues CRL to Astellas’ IZERVAY sNDA for geographic atrophy

Astellas application rejected by FDA; Cytokinetics strikes licensing deal with Bayer

From Mr. Mucus to the Super Bowl, pharma tries offbeat marketing strategies

Should Value Investors Buy Astellas Pharma (ALPMY) Stock?

Astellas withdraws Europe ACP application for AMD treatment

FDA approves Astellas’ VYLOY for gastric cancer treatment

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

Astella’s iota receives FDA go-ahead for bladder implant trial

FDA Grants iota Biosciences IDE Approval for First-In-Human Early Feasibility Study with Implantable Bladder Device

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

Protein prediction wins chemistry Nobel; Alnylam submits an all-important drug application

Performance Overview