Story perspectives

FDA Rejects Grace Therapeutics' GTx-104, Shares Plummet 43%

4/24/2026

Summary

Story summary

FDA declined approval of Grace Therapeutics' drug GTx-104 on April 23, 2026.
The agency found deficiencies in chemistry, manufacturing and controls and in non-clinical data, citing leachables from packaging and toxicology risks.
Grace Therapeutics' shares dropped 43% after the FDA decision.
The company will request an FDA meeting to discuss its injectable nimodipine for aneurysmal subarachnoid hemorrhage, a condition that accounts for about 5% of strokes.

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Story summary

FDA declined approval of Grace Therapeutics' drug GTx-104 on April 23, 2026.
The agency found deficiencies in chemistry, manufacturing and controls and in non-clinical data, citing leachables from packaging and toxicology risks.
Grace Therapeutics' shares dropped 43% after the FDA decision.
The company will request an FDA meeting to discuss its injectable nimodipine for aneurysmal subarachnoid hemorrhage, a condition that accounts for about 5% of strokes.