FY2022 Q3 Financial and R&D Update
Major R&D Milestones (Alpha)
Project
Quizartinib
TARLIGE® (mirogabalin)
DS-1211
•
DS-5670
Target Indication [phase, study name]
.
AML, 1L [Ph3, JP/US/EU/Asia]
•
DPNP
•
.
PXE [Ph2, US/EU]
• COVID-19 mRNA vaccine (original strain),
booster vaccination [Ph1/2/3, JP]
COVID-19 mRNA vaccine (original strain),
primary vaccination
[Ph3, JP]
As of Jan 2023
FY2022
H2
FY2023
H1
H2
• Approval
Approval
Filing accepted (US)
anticipated (JP/US)
anticipated (EU)
•
Filing accepted
•
(China)
Study Started
.
• TLR obtained
•
Filing accepted (JP)
TLR anticipated
• Study start
anticipated
.
COVID-19 mRNA vaccine (BA.4-5),
vaccination [Ph3, JP]
FLUMISTⓇ (VN-0107)
•
Nasal seasonal influenza vaccine [JP]
• Approval
anticipated (JP)
Bold: update from FY2022 Q2
AML: acute myeloid leukemia, DPNP: diabetic peripheral neuropathic pain, PXE: pseudoxanthoma elasticum, TLR: Top Line Results
Timeline indicated is based on the current forecast and subject to change
Daiichi-Sankyo
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