8legs: Grace therapeutics, inc.

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Grace updates corporate presentation detailing FDA CRL for GTx-104 and Phase 3 trial data

Grace reports an FDA Complete Response Letter for GTx-104 due to CMC and manufacturing readiness issues.
Grace plans a Type A meeting with the FDA and aims to resubmit after fixing CMC and leachable issues.
Phase 3 STRIVE-ON safety results show fewer hypotension events with GTx-104 versus oral nimodipine.
STRIVE-ON topline indicates a roughly 29% rise in 90-day recoveries with higher dose intensity.
Grace notes reduced ICU/ventilator days and fewer readmissions in STRIVE-ON topline data.
The updated exhibit 99.1 was incorporated into Grace's Form 8-K on April 27, 2026.
Grace positions a strategic path to NDA resubmission pending regulatory clearance.
Grace emphasizes the Phase 3 STRIVE-ON data for clinical and pharmacoeconomic benefits versus oral nimodipine.
The update ties into Grace's overall regulatory strategy and corporate presentation.
Grace aims to address leachable and manufacturing issues to advance NDA resubmission.

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