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

4/24/2026

26 3 Full Breakdown

Summary

Story summary

The U.S. Food and Drug Administration declined to approve Grace Therapeutics’ drug GTx-104 for aneurysmal subarachnoid hemorrhage.
The FDA’s refusal letter cited missing leachables data and manufacturing deficiencies at the contract manufacturer.
Grace Therapeutics’ shares fell 43% after the agency’s decision.
The company said it will request a meeting with the FDA to clarify the path forward.

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Story summary

The U.S. Food and Drug Administration declined to approve Grace Therapeutics’ drug GTx-104 for aneurysmal subarachnoid hemorrhage.
The FDA’s refusal letter cited missing leachables data and manufacturing deficiencies at the contract manufacturer.
Grace Therapeutics’ shares fell 43% after the agency’s decision.
The company said it will request a meeting with the FDA to clarify the path forward.