Stella Pharma Corporation
Notice Regarding the Regulatory Advisory Panel’s Deliberation Results for Stevoronin® for Recurrent Meningioma
A deliberation result was obtained for expanding the indication of the BNCT drug Stevoronin to recurrent meningioma; following the prescribed administrative procedures, the application is expected to proceed to marketing authorization. The application began in March 2026, and the impact on the fiscal year ending March 2027 is expected to be minor, while contributing to growth over the medium to long term.
Key Figures
- Progression-Free Survival: 14.4 months
- Objective Response Rate: 27.3%
- 1-Year Overall Survival Rate: 100%
- 2-Year Overall Survival Rate: 90.9%
AI要約
Summary of News
Stella Pharma Corporation obtained a deliberation result for expanding the indication of the BNCT drug Stevoronin® to recurrent meningioma. The submission was based on a physician-initiated Phase II randomized controlled trial. The treatment arm demonstrated a progression-free survival of 14.4 months versus 1.4 months in the control arm, a statistically significant difference. The objective response rate was 27.3% (not observed in the control arm), and survival outcomes were high, with a 1-year overall survival rate of 100% and a 2-year overall survival rate of 90.9%.
Outlook and Impact
This deliberation result is positioned as an important milestone for indication expansion and will broaden the patient population eligible for BNCT through the recurrent meningioma indication. Management explained that it will contribute to growth strategies including expansion of treatment facilities and overseas deployment. After completion of the prescribed administrative procedures, marketing authorization is expected; the impact on the fiscal year ending March 2027 is expected to be minor, while the BNCT business is expected to contribute to growth over the medium to long term.
Stella Pharma Corporation
Company overview · Stock price · Financial data · All IR
