← Back to Calendar
Live Company Data
NCM
Updated
just now
· Data: FMP
Current Price
$4.60
+120.10%
+$2.51 today
Day: $4.53 – $4.98
52-Week Range
Current price is at 82% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Indication
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.
⚠️ Not Investment Advice: This information is provided for educational purposes only.
PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period,
issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on
historical base rates and do not account for drug-specific factors. Always consult a financial advisor
before making investment decisions.
Discussion
Share your analysis, research, or questions about this catalyst. No account required.