← Back to Calendar

Filspari (sparsentan)

Travere Therapeutics · $TVTX
Priority Review Breakthrough Therapy Orphan Drug sNDA
PDUFA Date
April 13, 2026
Time Remaining
Today
Review Type
Priority (6 mo)
92%
Baseline PoA
sNDA/sBLA historical approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

Live Company Data NGM

Updated 24m ago · Data: FMP
Current Price
$28.96 +114.68%
+$15.47 today
Day: $28.29 – $31.47
Market Cap
N/A
Shares out: 92.37M
Float: 91.22M
52-Week Range
$13.88
$42.13
Current price is at 53% of 52-week range
Avg Volume
1.55M
Beta
0.87
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $TVTX catalysts → get weekly FDA alerts Subscribe Free on Substack →

Indication

Focal segmental glomerulosclerosis (FSGS)

Key Notes

PDUFA originally January 13, 2026. Extended to April 13, 2026 after FDA received a major amendment to the sNDA in January 2026. Filspari is already approved for IgAN; FSGS approval would make it the first drug specifically indicated for FSGS. DUPLEX Phase 3 showed significant proteinuria reduction (did not meet primary eGFR slope endpoint over 108 weeks). AdCom initially planned — FDA later determined no AdCom needed.
⚠️ 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