Astellas Pharma Inc

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Astellas Pharma, Inc. engages in the research, development, manufacture, import, and export of pharmaceutical products. Its products focus on therapeutic fields that include transplantation, immunology, infectious diseases, urology, oncology, neuroscience, diabetic complications, and metabolic diseases. The firm's global brands include Prograf, Vesicare, Protopic, Harnal, and Funguard. The company was founded by Kenji Yamanouchi in April 1923 and is headquartered in Tokyo, Japan.

TOKYO , Feb. 9, 2023 /PRNewswire/ -- 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.

Astellas Commits to Achieve Net Zero Greenhouse Gas Emissions by 2050

Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2022 Earnings Conference Call February 6, 2023 1:30 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Kenji Yasukawa - President and Chief Executive Officer ( Naoki Okamura - Representative Director, Executive Vice President, Chief Strategy Officer Minoru Kikuoka - Chief Financial Officer Yukio Matsui - Chief Commercial Officer Yoshitsugu Shitaka - Chief Scientific Officer ( Tadaaki Taniguchi - Chief Medical Officer Conference Call Participants Fumiyoshi Sakai - Credit Suisse Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Motoya Koutani - Nomura Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Akinori Ueda - Goldman Sachs Securities Seiji Wakao - JPMorgan Hiromitsu Ikeda Everyone, thank you very much for your participation of this announcement of the Financial Result in the FY '22, Third Quarter. I'm Ikeda from Corporate, Advocacy and Relations, serving as the moderator for today.

Astellas Pharma Inc. (ALPMF) Q3 2022 Earnings Call Transcript

TOKYO , Feb. 5, 2023 /PRNewswire/ -- 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 Director, President and CEO and its management structure.

Astellas Announces Change of President and CEO and Management Structure

TOKYO , Jan. 23, 2023 /PRNewswire/ -- 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 world wide product rights for antifungal agent MYCAMINE® (micafungin sodium/product name in Japan: FUNGUARD®).

Astellas Transfers MYCAMINE® Product Worldwide

TOKYO , Jan. 20, 2023 /PRNewswire/ -- 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 19 th for the FORTIS Ph1/2 clinical trial evaluating the safety, tolerability and efficacy of investigational AT845 in adults with late-onset Pompe disease (LOPD).

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

Data shows investigational zolbetuximab reduced risk of progression or death by 24.9% Study evaluated patients with Claudin 18.2-positive, HER2-negative locally advanced unresectable or metastatic gastric or gastroesophageal junction adenocarcinoma Data to be featured in late-breaking oral presentation TOKYO , Jan. 19, 2023 /PRNewswire/ -- 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 18.2 (CLDN18.2) targeted monoclonal antibody, plus mFOLFOX6 (a combination regimen that includes oxaliplatin, leucovorin and fluorouracil) versus placebo plus mFOLFOX6 in patients with CLDN18.2-positive, HER2-negative, locally advanced unresectable or metastatic gastric or gastroesophageal junction (GEJ) adenocarcinoma.

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

TOKYO , Jan. 19, 2023 /PRNewswire/ -- 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 (GHG) emissions reduction targets.

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

Basilea Pharmaceutica Ltd (SIX: BSLN), a commercial-stage biopharmaceutical company committed to meeting the needs of patients with severe bacterial and fungal infections, announced today that the continued strong sales of the antifungal Cresemba® (isavuconazole) achieved by its partner Astellas Pharma Inc. (“Astellas”) in the United States in 2022 exceeded the threshold triggering a milestone payment of CHF 20 million to Basilea.

Continued strong Cresemba® (isavuconazole) sales by Astellas in the U.S. trigger CHF 20 million sales milestone payment to Basilea

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) GLOW results, along with SPOTLIGHT topline results, mark progress in Astellas' gastric cancer development program TOKYO , Dec. 15, 2022 /PRNewswire/ -- 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 combination with CAPOX (a combination chemotherapy regimen that includes capecitabine and oxaliplatin).

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

Both Companies win a year of access to a prestigious life-science incubator in San Francisco, CA and to Astellas expertise to further their research Award helps biotech start-ups accelerate early research efforts TOKYO and SAN FRANCISCO , Dec. 13, 2022 /PRNewswire/ -- Astellas Venture Management LLC (President: William Watt, Ph.D., "AVM"), a wholly-owned venture capital subsidiary of Astellas Pharma Inc. (TSE: 4503) (President and CEO: Kenji Yasukawa, Ph.D.

Astellas and MBC BioLabs Announce 2022 Future Innovator Prize Awarded to Bespoke Biotherapeutics and Cellinfinity Bio

SKYLIGHT 4™ study results demonstrate the 52-week safety and tolerability of fezolinetant 30 mg and 45 mg once daily Pooled analyses will also be presented from SKYLIGHT 1™ and SKYLIGHT 2™ studies of fezolinetant, Astellas' investigational nonhormonal treatment for vasomotor symptoms (VMS) associated with menopause TOKYO, Oct. 12, 2022 /PRNewswire/ -- 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, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

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

TOKYO and HENNIGSDORF, Germany , Oct. 3, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE:4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Pantherna Therapeutics GmbH (CEO:Klaus Giese, Ph.D.

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

If authorized by the European Commission, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause TOKYO , Sept. 29, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.

European Medicines Agency Accepts Astellas' Marketing Authorization Application for Fezolinetant

Sponsorship provides a year of access to MBC BioLabs' life-science incubators and in-house Astellas expertise for scientific innovators TOKYO and SAN FRANCISCO, Sept. 19, 2022 /PRNewswire/ -- Astellas Venture Management LLC (President: William Watt, Ph.D.

Astellas and MBC BioLabs Announce Astellas Future Innovator Prize to Help Biotech Start-ups Accelerate Early Drug Discovery and Research Efforts

Clinical trial evaluated the safety and tolerability of 30 mg dose for the treatment of vasomotor symptoms (VMS) associated with menopause TOKYO , Sept. 4, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.

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

If approved by the FDA, fezolinetant would be a nonhormonal treatment for moderate to severe vasomotor symptoms associated with menopause TOKYO , Aug. 18, 2022 /PRNewswire/ -- 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, nonhormonal compound seeking approval for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

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

TOKYO , Aug. 2, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") today announced the following changes to its management structure effective October 1, 2022.

Astellas Announces Management Structure

Astellas Pharma, Inc. (OTCPK:ALPMF) Q1 2022 Earnings Conference Call August 1, 2022 3:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Minoru Kikuoka - CFO Yukio Matsui - CCO Bernie Zeiher - CMO Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Motoya Kohtani - Nomura Securities Seiji Wakao - JPMorgan Fumiyoshi Sakai - Credit Suisse Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Akinori Ueda - Goldman Sachs Securities Hiromitsu Ikeda [Foreign Language] Thank you very much. This is the FY 2022 First Quarter Financial Results Announcement.

Astellas Pharma, Inc. (ALPMF) Management on Q1 2022 Results Earnings Call Transcript

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 21, 2022 /PRNewswire/ -- 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 center.

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

CAMBRIDGE, United Kingdom and TOKYO , July 5, 2022 /PRNewswire/ -- Mogrify Limited (CEO: Darrin M. Disley, Ph.D.

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

TOKYO , June 26, 2022 /PRNewswire/ -- 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 on the FORTIS Phase 1/2 trial following the occurrence of a serious adverse event (SAE) of peripheral sensory neuropathy in one of the trial participants.

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

Application targets treatment of moderate to severe vasomotor symptoms associated (VMS) with menopause TOKYO , June 23, 2022 /PRNewswire/ -- 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 (FDA).

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

- 135,000 square-foot state-of-the-art gene therapy manufacturing facility located in Sanford, N.C., officially opened June 8 - Facility to support clinical- and commercial-scale manufacturing of Astellas' adeno-associated virus (AAV) vectors for gene therapies - Astellas' $100 million investment in Lee County facility to support more than 200 new jobs TOKYO and SANFORD, N.C.

Astellas Celebrates the Opening of Its New Large-Scale Gene Therapy Manufacturing Facility in North Carolina

- Collaboration to Accelerate Next-Generation Cancer Treatment  - TOKYO and CAMBRIDGE, Mass. , June 1, 2022 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D.

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

Abstracts represent exciting research progress across four cancers where patients have limited treatment options TOKYO , May 12, 2022 /PRNewswire/ -- 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 (EHA) 2022 Hybrid Congress from June 9-12.

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