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Lifyorli (relacorilant + nab-paclitaxel)

Corcept Therapeutics · $CORT
Standard Review Orphan Drug Fast Track NDA
PDUFA Date
March 25, 2026
Date Status
112d ago (past)
Review Type
Standard (10 mo)
93%
Baseline PoA
Orphan/rare disease designation approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: March 25, 2026
FDA Approved on 2026-03-25 (NDA220641). Source: FDA Drugs@FDA database.
Source: https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=220641

Live Company Data NCM

Updated 23m ago · Data: FMP
Current Price
$90.47 +24.32%
+$17.70 today
Day: $85.61 – $90.96
Market Cap
N/A
Shares out: 107.35M
Float: 89.94M
52-Week Range
$28.66
$95.11
Current price is at 93% of 52-week range
Avg Volume
1.10M
Beta
0.46
vs. S&P 500
Sector
Healthcare
Biotechnology
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
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Indication

Platinum-resistant epithelial ovarian, fallopian tube, or primary peritoneal cancer

Key Notes

FDA approved Lifyorli (relacorilant) plus nab-paclitaxel on March 25, 2026, ahead of the original PDUFA target of July 11, 2026. First approval for Corcept lead compound. Based on the Phase 3 ROSELLA trial (n=381), which met overall survival and PFS endpoints in platinum-resistant ovarian cancer after 1 to 3 prior lines including bevacizumab. Selective glucocorticoid receptor antagonist. Source: FDA and Corcept press release (March 25, 2026).
⚠️ 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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