other_material
confidence high
sentiment positive
materiality 0.80
Actuate reports Phase 2 elraglusib/GnP meets primary OS endpoint in mPDAC
ACTUATE THERAPEUTICS, INC.
- mOS 10.1 months vs 7.2 months for GnP alone, HR=0.63, log-rank p=0.01, 37% risk reduction.
- 12-month OS rate 44.1% vs 22.3% (p=0.0005); 24-month OS rate 13.8% vs 0%.
- ORR 29.0% vs 21.8%; DCR 61.3% vs 56.4%; mPFS 5.6 vs 5.1 months (HR=0.90, not significant).
- Safety profile similar between arms; transient, reversible visual impairments most common TRAEs.
- Company plans to request pre-NDA meeting with FDA in 2H 2025 for registration path.
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