Feb. 11 at 12:39 PM
$VERU
🚨 🚨 🚨
Cash balance of
$33.0M as of December 31, 2025
Operating loss improved to
$5.4M from
$10.2M (FY2026 Q1 vs FY2025 Q1)
Planned ~200-patient Phase 2b PLATEAU trial to start Q1 2026 with interim analysis Q1 2027
FDA confirmed enobosarm 3 mg as acceptable dose and outlined regulatory pathways
FDA efficacy pathway may require a ≥5% placebo-corrected weight-loss at 52 weeks for approval
If incremental weight loss is <5%, approval depends on demonstrating clinically meaningful functional or BMD benefits
Interim analysis not until Q1 2027, extending near-term readout timeline