← Back to Calendar

lorundrostat

Mineralys Therapeutics · $MLYS
Standard Review Fast Track NDA
PDUFA Date
December 22, 2026
Time Remaining
167 days
Review Type
Standard (10 mo)
85%
Baseline PoA
NDA standard 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 just now · Data: FMP
Current Price
$30.45 +118.32%
+$16.50 today
Day: $29.61 – $30.50
Market Cap
N/A
52-Week Range
$12.59
$47.65
Current price is at 51% of 52-week range
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $MLYS catalysts → get weekly FDA alerts Subscribe Free on Substack →

Indication

Uncontrolled or resistant hypertension (add-on to other antihypertensives)

Key Notes

FDA accepted the NDA with a PDUFA target action date of December 22, 2026. Aldosterone synthase inhibitor for uncontrolled and resistant hypertension, supported by the Phase 3 Launch-HTN and Advance-HTN trials plus the Transform-HTN open-label extension. Source: Mineralys 8-K and IR (NDA acceptance, Q1 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.

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