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News

Astellas is committed to providing timely and accurate information about our business, science and products. This section offers global resources for investors, journalists and media professionals. News and resources from our local affiliates can be viewed in the Local news section. If you are not an investor or journalist, click here.

Month Year

Mar 22, 2023

Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series

Data shows investigational zolbetuximab plus CAPOX reduced risk of progression or death by 31.3% vs CAPOX alone

TOKYO, March 22, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present detailed results from the Phase 3 GLOW trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...

Read more about Astellas Announces Positive Findings from Phase 3 GLOW Trial of Zolbetuximab during March ASCO Plenary Series
Mar 17, 2023

Phase 3 Study Shows XTANDI^® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer

Pfizer and Astellas announce positive topline results from Phase 3 EMBARK trial

NEW YORK and TOKYO, March 17, 2023 – Pfizer Inc. (NYSE: PFE) and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline...

Read more about Phase 3 Study Shows XTANDI^® (enzalutamide) plus Leuprolide Significantly Improves Metastasis-Free Survival in Men with Non-Metastatic Prostate Cancer
Mar 16, 2023

Astellas Announces Completion of Acquisition of Own Shares, and Cancellation of Treasury Stock

- Acquisition of own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act and cancellation of treasury stock pursuant to the provisions of Article 178 of the Companies Act -

TOKYO, March 16, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the status and the completion of acquisition of its own shares based on the resolution of the Board of Directors' meeting held on February...

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Mar 14, 2023

Astellas Announces Phase 3 China ARCHES Study of XTANDI^® Meets Primary Endpoint

XTANDI^® (enzalutamide) plus androgen deprivation therapy (ADT) significantly delays time to PSA progression compared to placebo plus ADT

TOKYO, MARCH 14, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 China ARCHES study of XTANDI® (enzalutamide) plus androgen deprivation therapy...

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Mar 13, 2023

Results from Astellas’ Pivotal Phase 3 SKYLIGHT 1^TM Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet

Treatment with fezolinetant resulted in statistically significant reductions in the frequency and severity of VMS and improvements in quality of life

TOKYO, March 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced The Lancet published detailed results from the pivotal Phase 3 SKYLIGHT 1™ study of fezolinetant, an investigational oral, nonhormonal...

Read more about Results from Astellas’ Pivotal Phase 3 SKYLIGHT 1^TM Study of Fezolinetant for Vasomotor Symptoms Due to Menopause Published in The Lancet
Mar 9, 2023

Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib

TOKYO and ROCKVILLE, Md., March 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and the Blood and Marrow Transplant Clinical Trials Network (BMT CTN) today announced topline results from the Phase 3 MORPHO clinical...

Read more about Astellas and BMT CTN Announce Topline Results from Phase 3 MORPHO Trial of Gilteritinib
Mar 9, 2023

Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer

– Clinical data submitted are consistent with global data and support enfortumab vedotin as a platinum-free option in patients with locally advanced or metastatic urothelial cancer who received prior treatment with a PD-1/L1 inhibitor and platinum-based chemotherapy –

TOKYO and BOTHELL, Wash.– March 9, 2023 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq: SGEN) today announced that the Center for Drug Evaluation (CDE) of the China National Medical Products...

Read more about Astellas and Seagen Announce China’s National Medical Products Administration Accepts Biologics License Application for Enfortumab Vedotin in Certain Patients with Locally Advanced or Metastatic Urothelial Cancer
Mar 1, 2023

Astellas Announces Status of Acquisition of Own Shares

- Under the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act -

TOKYO, March 1, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D. “the Company”) announced the status of acquisition of its own shares as stated below. The acquisition was implemented pursuant to the provision of its Articles of Incorporation...

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Feb 22, 2023

Announcement of Winning the 5th Japan Open Innovation Prize "Minister of Environment Award"

February 22, 2023 - Astellas Pharma Inc. (Headquarters: Tokyo; President and CEO: Kenji Yasukawa), The Mitsubishi Chemical Group, and CKD Corporation (Headquarters: Komaki, Aichi; President: Katsuhito Okuoka) won the Minister of Environment Award...

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Feb 22, 2023

Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease

Data presented at the 19th Annual WORLDSymposium^TM 2023

TOKYO, February 22, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced an update on preliminary safety and efficacy data from its ongoing FORTIS Phase1/2 clinical trial evaluating the safety...

Read more about Astellas Announces Update on Preliminary Safety and Efficacy Data from FORTIS Study of Investigational AT845 in Adults with Late-Onset Pompe Disease
Feb 20, 2023

Astellas Provides Update on Fezolinetant New Drug Application in U.S.

TOKYO, February 20, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the U.S. Food and Drug Administration (FDA) notified the company that it is extending the original priority...

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Feb 13, 2023

Astellas Supports Victims of the Earthquake in Turkey and Syria

TOKYO, February 13, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) would like to express its deepest sympathy to victims of the earthquake in Turkey and Syria...

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Feb 9, 2023

Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050

TOKYO, February 9, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced its commitment to achieve net zero greenhouse gas (GHG) emissions by 2050...

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Feb 6, 2023

Astellas Announces Change of President and CEO and Management Structure

TOKYO, February 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at a meeting of its Board of Directors, held today, approved changes of its Representative...

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Feb 6, 2023

Astellas Announces Acquisition of Own Shares and Cancellation of Treasury Stock

- Acquisition of own shares pursuant to the provision of its Articles of Incorporation in accordance with Article 459, paragraph 1 of the Companies Act and cancellation of treasury stock pursuant to the provisions of Article 178 of the Companies Act -

TOKYO, February 6, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that at the meeting of the Board of Directors held today, a resolution was adopted to acquire its own shares pursuant...

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Jan 24, 2023

Astellas Transfers MYCAMINE^® Product Worldwide

TOKYO, January 24, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that Astellas and Sandoz AG (“Sandoz”) have entered into an Asset Purchase Agreement, under which Astellas will transfer the...

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Jan 20, 2023

Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease

TOKYO, January 20, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has lifted the clinical hold on January 19th for the FORTIS Ph1/2 clinical trial evaluating the safety...

Read more about Astellas Announces Hold Lifted by FDA on FORTIS Clinical Trial of AT845 Investigational Treatment for Adult Patients with Late-Onset Pompe Disease
Jan 19, 2023

Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas Emissions

TOKYO, January 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the Science Based Targets initiative (SBTi)*1 has validated and approved its greenhouse gas...

Read more about Astellas Receives SBTi Approval for Revised Science-Based Climate Goals to Reduce Greenhouse Gas Emissions
Jan 19, 2023

Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium

Data shows investigational zolbetuximab reduced risk of progression or death by 24.9%

TOKYO, Jan. 19, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today will present detailed results from the Phase 3 SPOTLIGHT trial evaluating first-line treatment with zolbetuximab, an investigational first-in-class Claudin...

Read more about Astellas to Present Positive Findings from Phase 3 SPOTLIGHT Trial of Zolbetuximab during 2023 ASCO GI Cancers Symposium
Jan 9, 2023

Selecta Biosciences and Astellas Announce Exclusive Licensing and Development Agreement for Xork IgG Protease

Next-generation IgG protease candidate Xork to be licensed for development with AT845, an investigational Astellas Gene Therapies’ product, for the treatment of Pompe Disease

WATERTOWN, Mass. and TOKYO, Japan, January 9, 2023 – Selecta Biosciences, Inc. (NASDAQ: SELB, President and CEO: Carsten Brunn, Ph.D., “Selecta”), and Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” or “Astellas Gene Therapies”) today announced...

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Jan 4, 2023

Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN^® 0.4 mg/mL U.S. Patent Trial

TOKYO, January 4, 2023 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirmed the Court of Appeals for the Federal Circuit (CAFC) affirmed the earlier decision by the U.S. District Court for the District of Delaware that all asserted...

Read more about Astellas Confirms Unfavorable Federal Circuit Decision in LEXISCAN^® 0.4 mg/mL U.S. Patent Trial
Dec 22, 2022

Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging

TOKYO and Osaka, December 22, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, “Astellas”), Eisai Co., Ltd. (TSE: 4523, CEO: Haruo Naito, “Eisai”), Daiichi Sankyo Company, Limited (TSE: 4568, President : Sunao Manabe, "Daiichi Sankyo") and Takeda...

Read more about Astellas, Eisai, Daiichi Sankyo and Takeda Agree to Collaborate to Reduce Environmental Burden in the Field of Pharmaceutical Packaging
Dec 20, 2022

Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer

– This combination has the potential to be the first treatment option combining an antibody-drug conjugate plus an immunotherapy in this treatment setting –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. – December 20, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq: SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce FDA Acceptance of sBLA for PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) for the First-Line Treatment of Certain Patients With Locally Advanced or Metastatic Urothelial Cancer
Dec 16, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ GLOW trial, the second Phase 3 trial in CLDN18.2 positive, HER2-negative locally advanced unresectable or metastatic gastric and GEJ cancers, meets primary endpoint for progression-free survival (PFS) and key secondary endpoint for overall survival (OS)

TOKYO, December 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 GLOW clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 GLOW Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-negative Locally Advanced Unresectable or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Nov 29, 2022

Notice of Issuance of Unsecured Corporate Bonds

TOKYO, November 29, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today successfully priced its inaugural offering of dual-tranche JPY unsecured...

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Nov 17, 2022

Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers

Astellas’ SPOTLIGHT trial meets primary endpoint of progression-free survival (PFS) Full data to be presented at future scientific congress

TOKYO, November 17, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced positive topline results from the Phase 3 SPOTLIGHT clinical trial evaluating the efficacy and safety of zolbetuximab in...

Read more about Astellas Announces Zolbetuximab Meets Primary Endpoint in Phase 3 SPOTLIGHT Trial as First-Line Treatment in Claudin 18.2 Positive, HER2-Negative Locally Advanced or Metastatic Gastric and Gastroesophageal Junction (GEJ) Cancers
Oct 24, 2022

Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs

- Taysha Gene Therapies is an emerging leader in the development of AAV gene therapies; new collaboration aimed at enhancing development of two of Taysha’s novel product candidates for rare monogenic central nervous system diseases with serious unmet medical needs -

TOKYO and DALLAS, TEXAS, October 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Taysha Gene Therapies, Inc. (NASDAQ: TSHA, CEO: RA Session II, “Taysha”) today announced a strategic investment to support...

Read more about Astellas and Taysha Gene Therapies Announce Strategic Investment to Support Development of Taysha’s AAV-based Gene Therapy Programs
Oct 12, 2022

Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting

SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily

TOKYO, October 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 52-week results from the Phase 3 SKYLIGHT 4™ clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral...

Read more about Astellas to Present Findings from Phase 3 Long-Term Safety Study of Fezolinetant in Oral Session at The North American Menopause Society 2022 Annual Meeting
Oct 4, 2022

Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming

TOKYO and Hennigsdorf, Germany, October 4, 2022 - Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D., “Pantherna”) today announced that the companies...

Read more about Astellas and Pantherna Enter into a New Technology Evaluation Agreement for Research with Expanded Target Organ to Generate mRNA-Based Regenerative Medicine Programs Using Direct Reprogramming
Sep 30, 2022

European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, September 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the European Medicines Agency (EMA) has accepted for regulatory review the company’s marketing authorization application...

Read more about European Medicines Agency Accepts Astellas’ Marketing Authorization Application for Fezolinetant
Sep 26, 2022

Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL

TOKYO, September 26, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) confirms the U.S. District Court for the District of Delaware’s order granting an interim injunction enjoining Hospira from launching its generic version of...

Read more about Astellas Confirms District Court Decision for an Interim Injunction Against Hospira for LEXISCAN® 0.4mg/mL
Sep 12, 2022

Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer

– Results demonstrated a 64.5% confirmed objective response rate in patients treated with investigational combination of enfortumab vedotin and pembrolizumab –

TOKYO, BOTHELL, Wash. and RAHWAY, N.J. -- September 12, 2022 -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”), Seagen Inc. (Nasdaq:SGEN) and Merck (NYSE: MRK), known as MSD outside of the United States and Canada, today...

Read more about Astellas, Seagen and Merck Announce Results of Clinical Trial Investigating PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) and PADCEV as Monotherapy in First-Line Advanced Urothelial Cancer
Sep 5, 2022

Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China

Clinical trial evaluated the safety and tolerability of 30 mg dose for the treatment of vasomotor symptoms (VMS) associated with menopause

TOKYO, September 5, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced topline results from the Phase 3 MOONLIGHT 3™ clinical trial in women in mainland China evaluating the long-term safety...

Read more about Astellas Announces Topline Results from Phase 3 Long-Term Safety Study of Fezolinetant in Mainland China
Aug 18, 2022

U.S. FDA Accepts Astellas’ New Drug Application for Fezolinetant

If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause

TOKYO, August 18, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced that the U.S. Food and Drug Administration (FDA) has accepted the company’s New Drug Application (NDA) for fezolinetant, an investigational oral...

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Aug 2, 2022

Astellas Announces Management Structure

TOKYO, August 2, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced the following changes to its management structure effective...

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Jul 26, 2022

Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer

– Companies plan to discuss results with regulatory authorities –

TOKYO and BOTHELL, Wash.--July 26, 2022—Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Seagen Inc. (Nasdaq:SGEN) today announced positive topline results from the phase 1b/2 EV-103 clinical trial...

Read more about Astellas and Seagen Announce Positive Topline Results For PADCEV® (enfortumab vedotin-ejfv) with KEYTRUDA® (pembrolizumab) as First-Line Treatment for Advanced Urothelial Cancer
Jul 22, 2022

Astellas Unveils Plans to Open New Biotech Campus in South San Francisco

New 154,000 square-foot facility will provide a West Coast center with a focus on research, innovation, and commercial collaboration across corporate and program areas

TOKYO and SAN FRANCISCO - July 22, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced plans to create an integrated biotechnology campus in South San Francisco as its West Coast innovation and research...

Read more about Astellas Unveils Plans to Open New Biotech Campus in South San Francisco
Jul 5, 2022

Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss

Cambridge, UK, and Tokyo, Japan, 05 July 2022: Mogrify Limited (CEO: Darrin M. Disley, Ph.D., “Mogrify®”), a biopharmaceutical company transforming the lives of patients through a novel class of in vivo reprogramming therapies, and Astellas Pharma Inc...

Read more about Mogrify and Astellas announce collaboration to conduct research on in vivo regenerative medicine approaches to address sensorineural hearing loss
Jun 30, 2022

Sales Pilot of Disposable Holter ECG Device "EG Holter™" Begins

TOKYO, OSAKA, and IWATE, June 30, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas” ), Nitto Denko Corporation (TSE: 6988, President: Hideo Takasaki, “Nitto”), and M. Heart Co., Ltd. (President and CEO: Yoshimi...

Read more about Sales Pilot of Disposable Holter ECG Device "EG Holter™" Begins
Jun 28, 2022

Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)

- iADCs are a next-generation modality for treating cancer and designed to boost anti-cancer activity, offering potential new options for patients who do not respond to existing cancer immunotherapies -

TOKYO and SOUTH SAN FRANCISCO, Calif., June 28, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and Sutro Biopharma, Inc. (NASDAQ: STRO, CEO: William J. Newell, JD, “Sutro”) today announced a worldwide, strategic...

Read more about Astellas and Sutro Biopharma Announce Worldwide Strategic Collaboration to Advance Novel Immunostimulatory Antibody-Drug Conjugates (iADCs)
Jun 27, 2022

Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease

TOKYO, June 27, 2022 - Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced that the US Food and Drug Administration (FDA) has placed a clinical hold...

Read more about Astellas Announces FDA Update on the FORTIS Clinical Trial of AT845 in Adults with Late-Onset Pompe Disease
Jun 24, 2022

Astellas Submits Fezolinetant New Drug Application to U.S. FDA

Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause

TOKYO, June 24, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced a New Drug Application (NDA) for fezolinetant has been submitted to the U.S. Food and Drug Administration...

Read more about Astellas Submits Fezolinetant New Drug Application to U.S. FDA
Jun 1, 2022

Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology

- Collaboration to Accelerate Next-Generation Cancer Treatment -

TOKYO and Cambridge, Mass., June 1, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) and GO Therapeutics, Inc. (Co-Founder and CEO: Constantine Theodoropulos, “GO”) today announced that Xyphos Biosciences...

Read more about Astellas and GO Therapeutics Enter into Strategic Research and License Agreement to Develop Novel Antibodies for Immuno-Oncology
May 20, 2022

Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial

TOKYO, May 20, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today confirmed the U.S. District Court for the District of Delaware ruling that all asserted claims of the 8,106,183; 8, 524,883; and RE47301 patents for LEXISCAN®...

Read more about Astellas Confirms Unfavorable District Court Decision in LEXISCAN® 0.4mg/mL U.S. Patent Trial
May 19, 2022

Astellas Analysis Shows No Evidence of Increased Risk of Cardiovascular Events or Mortality with Roxadustat Compared with Erythropoiesis-Stimulating Agents (ESAs) at 59th ERA Congress 2022

Pooled Phase 3 data for anemia of CKD patients, incident dialysis or not receiving dialysis from the ALPINE Phase 3 clinical trial program

TOKYO, May 19, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) today announced results from a pooled analysis of patients with symptomatic anemia associated with chronic kidney disease (CKD) who are non-dialysis...

Read more about Astellas Analysis Shows No Evidence of Increased Risk of Cardiovascular Events or Mortality with Roxadustat Compared with Erythropoiesis-Stimulating Agents (ESAs) at 59th ERA Congress 2022
May 16, 2022

Astellas to Present New Research Further Supporting Roxadustat Safety in the Treatment of Symptomatic Anemia of Chronic Kidney Disease at 59th ERA Congress 2022

Three abstracts provide additional insights into roxadustat safety profile and effect on iron parameters

TOKYO, May 16, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) announced the presentation of new roxadustat data at the 59th European Renal Association (ERA) Congress, taking place May 19–22, 2022...

Read more about Astellas to Present New Research Further Supporting Roxadustat Safety in the Treatment of Symptomatic Anemia of Chronic Kidney Disease at 59th ERA Congress 2022
May 12, 2022

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme

TOKYO, May 12, 2022– Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) today announced that at the meeting of the Board of Directors held today...

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May 12, 2022

Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme and Performance-linked Stock Delivery Scheme for the Domestic and Global Astellas Group Executives

TOKYO, May 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “the Company”) announced that at the meeting of the Board of Directors held today...

Read more about Notice Regarding Continuation of the Performance-linked Stock Compensation Scheme and Performance-linked Stock Delivery Scheme for the Domestic and Global Astellas Group Executives
May 12, 2022

Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress

Abstracts represent exciting research progress across four cancers where patients have limited treatment options

TOKYO, May 12, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will share new research during the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting from June 3-7 and the European Hematology Association...

Read more about Astellas Highlights Data on Advanced and Rare Cancers during 2022 ASCO Annual Meeting and EHA 2022 Hybrid Congress
May 6, 2022

Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting

Astellas’ investigational nonhormonal treatment meets all primary endpoints, significantly reducing the frequency and severity of vasomotor symptoms associated with menopause

TOKYO, May 6, 2022 – Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., “Astellas”) will present 12-week results from the pivotal Phase 3 SKYLIGHT 1™ clinical trial examining the efficacy and safety of fezolinetant, an investigational oral...

Read more about Astellas to Present 12-Week Data from Pivotal Phase 3 SKYLIGHT 1™ Trial of Fezolinetant in Oral Session at the American College of Obstetricians and Gynecologists Annual Meeting

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