← Back to Calendar

ulixacaltamide (PRAX-944)

Praxis Precision Medicines · $PRAX
Priority Review Breakthrough Therapy Fast Track NDA
PDUFA Date
August 17, 2026
Time Remaining
119 days
Review Type
Priority (6 mo)
90%
Baseline PoA
NDA priority review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NMS

Updated 2m ago · Data: FMP
Current Price
$342.50 +913.61%
+$308.71 today
Day: $324.87 – $346.35
Market Cap
N/A
Shares out: 27.85M
Float: 25.78M
52-Week Range
$32.78
$356.00
Current price is at 96% of 52-week range
Avg Volume
448K
Beta
2.97
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $PRAX catalysts → get weekly FDA alerts Subscribe Free on Substack →

Indication

Essential tremor (ET) — first therapy specifically designed for ET

Key Notes

NDA submitted ~mid-February 2026. PDUFA estimated ~August 17, 2026 (6-month priority review based on Breakthrough Therapy Designation; exact date TBC pending FDA acceptance announcement). Essential3 Phase 3 program demonstrated statistically significant and clinically meaningful improvement in activities of daily living vs placebo, with durability of response and added benefit on background therapy. Most common movement disorder: ~7 million US patients. No FDA-approved drugs specifically for ET currently exist — treatment is off-label beta-blockers/primidone. Peak revenue potential estimated >$10B. Sister program relutrigine (SCN2A/SCN8A DEEs, PDUFA Sept 27) also under review.
⚠️ 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.

Rate limit: 5/hr per email
Loading comments...
← Back to Full Calendar