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U.S. FDA ACKNOWLEDGES ASTELLAS' RESUBMISSION OF BIOLOGICS LICENSE APPLICATION FOR ZOLBETUXIMAB AND SETS NEW ACTION DATE
Prnewswire· 2024-05-31 02:30
If approved, the investigational therapy would offer a new treatment option for patients with advanced gastric and gastroesophageal junction cancers as the first and only CLDN18.2-targeted therapy in the U.S. TOKYO, May 30, 2024 /PRNewswire/ -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Naoki Okamura, "Astellas") today announced that the U.S. Food and Drug Administration (FDA) has acknowledged the company's resubmission of the Biologics License Application (BLA) for zolbetuximab, a first-in-class i ...
Astellas(ALPMY) - 2023 Q4 - Earnings Call Transcript
2024-04-26 22:00
Astellas Pharma Inc. (OTCPK:ALPMF) Q4 2023 Results Conference Call April 25, 2024 4:00 AM ET Company Participants Hiromitsu Ikeda - Chief Communications and Investor Relations Officer Naoki Okamura - President and Chief Executive Office Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Atsushi Kitamura - Chief Financial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Shinichiro Muraoka - Morgan Stanl ...
Astellas(ALPMY) - 2023 Q3 - Earnings Call Transcript
2024-02-05 18:08
Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2023 Results Earnings Conference Call February 5, 2024 2:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy & Relations Atsushi Kitamura - Chief Financial Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley MUFJ Securities Akinori Ueda - Goldman Sachs Securities Seiji ...
Astellas(ALPMY) - 2023 Q2 - Earnings Call Presentation
2023-11-01 14:31
Q2/FY2023 FINANCIAL RESULTS ENDED SEPTEMBER 30, 2023 Naoki Okamura President and CEO Astellas Pharma Inc. November 1, 2023 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the informati ...
Astellas(ALPMY) - 2023 Q2 - Earnings Call Transcript
2023-08-07 02:42
Astellas Pharma Inc. (OTCPK:ALPMF) Q2 2023 Earnings Conference Call August 1, 2023 4:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Naoki Okamura - Representative Director, President and CEO Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Kazuaki Hashiguchi - Daiwa Securities Naomi Kumagai - Mitsubishi UFJ Morgan Stanle ...
Astellas(ALPMY) - 2023 Q3 - Earnings Call Presentation
2023-02-06 18:55
Q3/FY2022 FINANCIAL RESULTS ENDED DECEMBER 31, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. February 6, 2023 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of t ...
Astellas(ALPMY) - 2022 Q3 - Earnings Call Transcript
2022-10-31 21:07
Astellas Pharma Inc. (OTCPK:ALPMF) Q3 2022 Earnings Conference Call October 31, 2022 4:00 AM ET Company Representatives Kenji Yasukawa - Chief Executive Officer Yoshitsugu Shitaka - CScO, Chief Scientific Officer Minoru Kikuoka - Chief Financial Officer Tadaaki Taniguchi - Chief Medical Officer Bernie Zeiher - Chief Medical Officer Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Conference Call Participants Hidemaru Yamaguchi - Citigroup Securities Motoya Koutani - Nomura Securities Fumiyoshi Sakai ...
Astellas(ALPMY) - 2022 Q1 - Earnings Call Presentation
2022-08-01 04:56
Q1/FY2022 FINANCIAL RESULTS ENDED JUNE 30, 2022 Minoru Kikuoka Chief Financial Officer (CFO) Astellas Pharma Inc. August 1, 2022 CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING INFORMATION In this material, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas Pharma. These statements are based on management's current assumptions and beliefs in light of the inf ...
Astellas(ALPMY) - 2022 Q4 - Earnings Call Transcript
2022-04-27 18:53
Astellas Pharma Inc. (OTCPK:ALPMF) Q4 2022 Results Conference Call April 27, 2023 3:00 AM ET Company Participants Hiromitsu Ikeda - Corporate Head, Advocacy and Relations Naoki Okamura - Representative Director, President and CEO Yoshitsugu Shitaka - Chief Scientific Officer Tadaaki Taniguchi - Chief Medical Officer Claus Zieler - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citi Group Kazuaki Hashiguchi - Daiwa Securities Shinichiro Muraoka - Morgan Stanley MUFG Securities Aki ...
Astellas(ALPMY) - 2022 Q1 - Earnings Call Transcript
2021-07-31 19:44
Astellas Pharma, Inc. (OTCPK:ALPMF) Q1 2022 Results Conference Call July 30, 2021 3:00 AM ET Company Participants Naoki Okamura - CSO & CFO Mike Kitagawa - Senior VP of Development Project Management Yukio Matsui - Chief Commercial Officer Conference Call Participants Hidemaru Yamaguchi - Citigroup Kazuaki Hashiguchi - Daiwa Securities Seiji Wakao - JPMorgan Fumiyoshi Sakai - Credit Suisse Shinichiro Muraoka - Morgan Stanley Naoki Okamura Hello, everyone. I'm CSO and CFO at Astellas Pharma Inc. I'm Naoki Ok ...