Aneurysmal subarachnoid hemorrhage (aSAH) — IV ganaxolone to prevent delayed cerebral ischemia
Key Notes
NDA accepted by FDA August 22, 2025. PDUFA target date April 23, 2026. STRIVE-ON Phase 3 safety trial data supports NDA; abstract accepted for AAN 2026 presentation. GTx-104 is an IV formulation of ganaxolone, a neuroactive steroid / GABA-A positive allosteric modulator. Indication: reduce risk of delayed cerebral ischemia (DCI) after aneurysmal subarachnoid hemorrhage — a life-threatening complication affecting ~30% of aSAH survivors and a leading cause of post-hemorrhage disability. No FDA-approved drugs specifically for DCI prevention currently exist. Grace Therapeutics is a small-cap binary event — approval would be company's first commercial product. Sub-$100M market cap.
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PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
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