Investor Presentaiton
Research and Development
Main Events / Targets for FY2023 (as of May 15, 2023)
Psychiatry
&
Neurology
Oncology
Others
Frontier
☐ ulotaront
□ Obtain results from two Phase 3 studies for schizophrenia (□ DIAMOND 1 □ DIAMOND 2)
(SEP-363856) ☐ Submit NDA for schizophrenia in the U.S.
☐ Advance Phase 2/3 study in Japan and China for schizophrenia
□ Advance Phase 2/3 studies for two additional indications (aMDD, GAD)
SEP-4199: Advance Phase 3 studies for Bipolar I depression
Allogeneic iPS cell-derived products (Retinal pigment epithelium tear): Start clinical study in Japan
☐ Allogeneic iPS cell-derived products (Parkinson's disease): Start clinical study in the U.S.
☐ Complete manufacturing plant in the U.S. (for RETHYMICⓇ and allogeneic iPS cell-derived products)
Advance early Phase studies
☐ relugolix: Obtain approval for endometriosis in Europe
vibegron: Obtain results from Phase 3 study and submit sNDA for overactive bladder (OAB) with benign
prostatic hyperplasia in the U.S.
rodatristat ethyl: Obtain results from Phase 2 study for pulmonary arterial hypertension (PAH)
☐ universal influenza vaccine, malaria vaccines: Promote joint research and development projects
Launch product: (Japan) Automated blood collection/stabilization device
☐ Promoting the current themes and generating evidence data for maximizing the value of the launched products
Sumitomo Pharma
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