Introduction of NS-401 (tagraxofusp) and preparation for development
First written in FY2021. 9 of 14 entries say "Restated". Latest entry: FY2026.
No other company in this theme has enough history to compare yet.
- FY2026AchievedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial was conducted from July 2022. A marketing authorisation application was filed in March 2025, marketing approval was obtained in December 2025, and the product was launched in March 2026.」
NS-401 was launched in March 2026 after the filing of a marketing authorisation application and receipt of marketing approval in December 2025. - 2026-05-15AchievedRevision to earnings forecast
「NS-401（一般名：タグラキソフスプ）」については、2021年3月にメナリーニ社（イタリア）から導入し、2022年7月より第一／二相試験を実施中です。2025年3月に承認申請を行い、2025年12月に製造販売承認取得、2026年3月に発売しました。」
NS-401について、承認申請から製造販売承認取得を経て発売に到達した。 - FY2025AdvancedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022. A marketing authorisation application was filed in March 2025.」
NS-401 progressed from the Phase 1/2 trial stage to the stage of filing a marketing authorisation application in March 2025. - FY2025-H1RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2024-Q3RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2024-Q2RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2024-Q1RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2023RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2023-Q2RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial has been under way since July 2022.」
The Company reiterated that, following in-licensing, a Phase 1/2 trial of NS-401 that began in July 2022 is under way. - FY2023-Q1AdvancedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and a Phase 1/2 trial was initiated in July 2022.」
NS-401 progressed from the development preparation stage following in-licensing to the stage of initiating a Phase 1/2 trial in July 2022. - FY2022-Q3RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and preparations for development are under way.」
The Company reiterated the status of NS-401 following its in-licensing and during preparations for development. - FY2022-Q2RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and preparations for development are under way.」
The Company reiterated the status of NS-401 following its in-licensing and during preparations for development. - FY2022-Q1RestatedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and preparations for development are under way.」
The Company reiterated the status of NS-401 following its in-licensing and during preparations for development. - FY2021First statedAnnual report
「NS-401 (generic name: tagraxofusp), a treatment for blastic plasmacytoid dendritic cell neoplasm, was licensed in from Menarini (Italy) in March 2021, and preparations for development are under way.」
The Company stated for the first time that it had licensed in NS-401 from Menarini and was preparing for development.