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Otsuka Holdings Co., Ltd. (TSE:4578) news

Otsuka Holdings Co., Ltd. news releases on 6ix. Latest, Oct 7, 2026: Otsuka Completes Rolling Submission of Supplemental Biologics License Application (sBLA)…

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Press releases & updates

Otsuka Completes Rolling Submission of Supplemental Biologics License Application (sBLA) for Traditional Approval of VOYXACT in U.S.

October 7, 2026

NDA Submission Initiated for Zipalertinib Plus Chemotherapy in First-Line EGFR Exon 20 Insertion Mutation NSCLC for Review Under FDA RTOR Program

October 1, 2026

Notice regarding the status of share repurchases

October 1, 2026

Otsuka Presents New Phase 3b Results for SIMTRIYO® (centanafadine) Highlighting Consistent Improvements Across ADHD Symptoms, Anxiety, and Associated Features in Adults with ADHD and Comorbid Anxiety Disorders at Psych Congress 2026

September 18, 2026

Zipalertinib Plus Chemotherapy Demonstrates 6-Month Median PFS Benefit in Phase 3 Trial in First-Line EGFR Exon 20 Insertion Mutation NSCLC

September 13, 2026

Zipalertinib Plus Chemotherapy Meets Primary PFS Endpoint in Planned Interim Analysis of Phase 3 REZILIENT3 Trial

August 12, 2026

Otsuka Unveils Unprecedented Phase 3 VISIONARY Two-Year eGFR Results Demonstrating VOYXACT® (sibeprenlimab-szsi) Stabilizes Kidney Function Decline to Baseline Physiologic Rate, Fundamentally Altering Disease Progression in IgA Nephropathy (IgAN)

August 3, 2026

Consolidated Financial Results for the Six-Month Period Ended June 30, 2026 [IFRS]

July 31, 2026

Notice Regarding Revisions of Consolidated Results Forecast for the first half of FY2026

July 27, 2026

Otsuka Receives FDA Approval for First-in-Class SIMTRIYO® (centanafadine) for the Treatment of Attention-Deficit Hyperactivity Disorder (ADHD) in Adults and Pediatric Patients Aged 6 Years and Older

July 24, 2026

Otsuka Reports Positive Phase 3 VISIONARY Two-Year eGFR Results for VOYXACT in IgAN

July 1, 2026

Otsuka Presents Positive Interim Phase 3 VISIONARY eGFR Data Showing VOYXACT Preserved Kidney Function Over 12 Months in IgA Nephropathy

June 4, 2026

Notice regarding the status of share repurchases

June 1, 2026