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ulixacaltamide (PRAX-944)

Praxis Precision Medicines · $PRAX
Priority Review Breakthrough Therapy Fast Track NDA
PDUFA Date
August 17, 2026
Time Remaining
139 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 4m ago · Data: FMP
Current Price
$276.44 +615.05%
+$237.78 today
Day: $271.94 – $296.00
Market Cap
N/A
52-Week Range
$26.70
$356.00
Current price is at 76% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.

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.

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