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Grace Therapeutics plans FDA meeting after Complete Response Letter on GTx-104 for brain hemorrhage treatment

Company Fundamentals
18 Jun 2026
GlobeNewsWire
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Neutral
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Grace Therapeutics announced its 2026 fiscal results and a planned Type A meeting with the FDA following a Complete Response Letter (CRL) for its drug GTx-104, an IV nimodipine formulation for aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA's CRL cited issues in manufacturing and non-clinical data but no clinical deficiencies. Grace aims to address these and resubmit the NDA, supported by positive Phase 3 trial results showing safety and efficacy benefits over oral nimodipine. The company reported a reduced net loss of $7.8 million for fiscal 2026 and expects its cash runway to last at least 12 months while preparing for potential FDA approval and commercialization.

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