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Month Year

Dec 11, 2023

Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause

First-in-class treatment option reduces number and intensity of hot flashes and night sweats

TOKYO, December 11, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced the European Commission (EC) on December 7 approved VEOZATM (fezolinetant) 45 mg once daily for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause...

Read more about Astellas’ VEOZA^TM (fezolinetant) Approved by European Commission for Treatment of Vasomotor Symptoms Associated with Menopause
Nov 30, 2023

Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy

Phase 3b DAYLIGHT study being presented at ESG 2023 demonstrated fezolinetant 45 mg achieved statistically significant reductions in the frequency and severity of moderate to severe vasomotor symptoms due to menopause and patient-reported sleep disturbance at 24 weeks

TOKYO, November 30, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) will present 24-week results from the Phase 3b DAYLIGHT clinical trial examining the efficacy and safety of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of...

Read more about Astellas’ Fezolinetant Reduces Frequency and Severity of VMS Associated with Menopause in Women Considered Unsuitable for Hormone Therapy
Nov 30, 2023

FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer

– Results of pivotal confirmatory trial found the enfortumab vedotin plus pembrolizumab combination significantly extended overall survival and progression-free survival vs standard platinum containing chemotherapy–

TOKYO and BOTHELL, Wash.– November 30, 2023 – Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that on November 30, 2023 the U.S. Food and Drug Administration (FDA) accepted for priority review a supplemental Biologics License Application (sBLA) for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as a combination therapy for the treatment...

Read more about FDA Grants Priority Review for Supplemental Biologics License Application (sBLA) of PADCEV^® (enfortumab vedotin-ejfv) with KEYTRUDA^® (pembrolizumab) for First-Line Treatment of Advanced Bladder Cancer
Nov 16, 2023

University of Tsukuba and Astellas Confirm a Strategic Partnership

- Accelerating the development of the life science ecosystem centered on Tsukuba -

TOKYO and IBARAKI, November 16, 2023 - University of Tsukuba (President: Kyosuke Nagata) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that they have signed a letter of confirmation regarding a strategic partnership to accelerate the digitalization of the drug...

Read more about University of Tsukuba and Astellas Confirm a Strategic Partnership
Nov 16, 2023

Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting

XTANDI becomes the first and only androgen receptor signaling inhibitor approved for use with or without a GnRH analog therapy* in nonmetastatic castration-sensitive prostate cancer

TOKYO and NEW YORK, November 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Pfizer Inc. (NYSE: PFE) today announced that the companies received an approval by the U.S. Food and Drug Administration (FDA) of a supplemental New Drug Application for XTANDI®...

Read more about Pfizer and Astellas' XTANDI^® Approved by U.S. FDA in Earlier Prostate Cancer Treatment Setting
Nov 15, 2023

Astellas to Acquire Propella Therapeutics

- Acquire PRL-02, prostate cancer treatment program being developed by Propella Therapeutics -

TOKYO and PITTSBORO, N.C., November 15, 2023 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) and Propella Therapeutics, Inc. (President and CEO: William Moore, “Propella”) today announced that Astellas, through a US subsidiary, and Propella have entered into a merger agreement...

Read more about Astellas to Acquire Propella Therapeutics
Nov 15, 2023

Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology

Preliminary data analysis on ventilator dependence and motor improvement are reported alongside overall safety findings

TOKYO, November 15, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that The Lancet Neurology published a preliminary data analysis from the ASPIRO trial, evaluating the safety and efficacy of investigational AT132 (resamirigene bilparvovec), an adeno-associated...

Read more about Astellas Announces Data from ASPIRO Study in X-linked Myotubular Myopathy Published in The Lancet Neurology
Nov 4, 2023

IZERVAY^TM (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years

-Phase 3 results presented at the AAO Annual Meeting demonstrated the IZERVAY treatment effect more than doubled over 2 years compared to 1 year-

TOKYO, November 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced results from the GATHER2 Phase 3 clinical trial, demonstrating IZERVAY™ (avacincaptad pegol intravitreal solution) continued to reduce the rate of geographic atrophy (GA) lesion growth for both...

Read more about IZERVAY^TM (avacincaptad pegol intravitreal solution) Monthly or Every Other Month Reduced Geographic Atrophy Lesion Growth Through 2 Years
Oct 25, 2023

Astellas Ranked First in Pharmaceuticals Sector of “2023 Award for Excellence in Corporate Disclosure” by Securities Analysts Association of Japan

TOKYO, October 25, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, “Astellas”) today announced that the company has ranked first in the pharmaceuticals sector for the “2023 Award for Excellence in Corporate Disclosure” granted by the Securities Analysts Association of Japan (SAAJ) to...

Read more about Astellas Ranked First in Pharmaceuticals Sector of “2023 Award for Excellence in Corporate Disclosure” by Securities Analysts Association of Japan
Oct 22, 2023

Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV^®(enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) in First-Line Advanced Bladder Cancer

– Risk of death was reduced by 53% in patients treated with enfortumab vedotin plus pembrolizumab compared to chemotherapy –

TOKYO and BOTHELL, Wash. – October 22, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Naoki Okamura, “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced results from the Phase 3 EV-302 clinical trial (also known as KEYNOTE-A39) for PADCEV® (enfortumab vedotin-ejfv) in combination...

Read more about Groundbreaking EV-302 Trial Significantly Extends Overall Survival and Progression-Free Survival in Patients Treated with PADCEV^®(enfortumab vedotin-ejfv) and KEYTRUDA^® (pembrolizumab) in First-Line Advanced Bladder Cancer

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