Grace Therapeutics updated its corporate presentation on April 27, 2026, detailing GTx-104 regulatory updates including FDA Complete Response Letter and plans for NDA resubmission after Type A meeting.
Key takeaways
Company updated corporate presentation attached as Exhibit 99.1.
FDA issued Complete Response Letter for GTx-104 NDA due to CMC data, nonclinical, and manufacturing issues; no clinical deficiencies.
Plans to request Type A meeting with FDA to align on path forward for GTx-104 resubmission.
STRIVE-ON Phase 3 trial met primary endpoint with GTx-104 showing improved outcomes vs oral nimodipine.
GTx-104 is novel IV nimodipine with Orphan Drug Status and multi-layered IP protection.