MLYS Mineralys Therapeutics, Inc.
Price Chart
Executive Summary
The FDA has accepted Mineralys Therapeutics' New Drug Application (NDA) for lorundrostat, a treatment for adult hypertension, and set a PDUFA action date of December 22, 2026. While the Phase 2 Explore-OSA trial missed its primary endpoint of reducing apnea-hypopnea index in sleep apnea patients, it showed clinically meaningful blood pressure reduction and a favorable safety profile, supporting the drug's potential in resistant hypertension.
Actionable Insight
Traders should monitor for FDA feedback ahead of the December 2026 PDUFA date; any safety concerns or delays could trigger volatility. Positive momentum supports long positioning ahead of decision, but risks remain around approval and commercial uptake.
Key Facts
- FDA accepted NDA for lorundrostat with PDUFA date of December 22, 2026
- Lorundrostat demonstrated 6.2 mmHg placebo-adjusted systolic BP reduction in Explore-OSA trial (p < 0.0003)
- Primary endpoint (AHI reduction) in Explore-OSA trial was not met
- Drug showed favorable safety profile with no serum potassium excursions above 5.5 mmol/L
- NDA supported by positive Phase 3 Launch-HTN and Phase 2 Advance-HTN trials
Financial Impact
Potential blockbuster approval in 2026 for a $219B U.S. hypertension market with high unmet need
Risk Factors
- FDA may require additional data or delay approval despite acceptance
- Failure in Explore-OSA primary endpoint may raise questions about broader indications
- Commercial success depends on differentiation from existing antihypertensives
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3252329 |
Filters
| Type | Now | ||||
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Jun 3, 2026
6d ago
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8-K
| $25.06 $25.05 | ▼ −0.04% | ▼ −0.44% | $22.50 (−10.22%) |
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Jun 3, 2026
6d ago
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Press Release
| $25.06 $25.05 | ▼ −0.04% | ▼ −0.44% | $22.50 (−10.22%) |
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May 30, 2026
10d ago
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Press Release
| $31.11 $28.85 | ▼ −7.26% | ▼ −7.41% | $22.50 (−27.68%) |
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May 18, 2026
22d ago
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Press Release
| $26.03 $28.43 | ▲ +9.22% | ▲ +8.18% | $22.50 (−13.56%) |
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May 12, 2026
28d ago
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144
| $26.86 $26.86 | · 0.00% | ▲ +0.00% | $22.50 (−16.23%) |
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May 11, 2026
29d ago
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144
| $29.26 $29.26 | · 0.00% | ▼ −0.54% | $22.50 (−23.10%) |
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Apr 17, 2026
7w ago
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144
| $30.07 $28.78 | ▼ −4.29% | ▼ −3.64% | $22.50 (−25.17%) |
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Apr 13, 2026
8w ago
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144
| $27.32 $30.42 | ▲ +11.35% | ▲ +10.57% | $22.50 (−17.64%) |
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Apr 13, 2026
8w ago
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144
| $27.32 $30.42 | ▲ +11.35% | ▲ +10.57% | $22.50 (−17.64%) |
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Apr 9, 2026
8w ago
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Insider Cluster
| $27.17 $26.62 | ▲ +2.02% | ▲ +1.96% | $22.50 (+17.19%) |
US Market Status
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