Mineralys Announces FDA Acceptance of Lorundrostat NDA, PDUFA Date Set for December 22, 2026
MLYS•The FDA accepted Mineralys Therapeutics’ NDA for lorundrostat for resistant hypertension, assigning a December 22, 2026 PDUFA date based on five trials showing meaningful blood pressure reductions. It held $646.1 million in cash and investments March 31, expects funding into 2028, and logged a Q1 net loss of $39.3 million.
1. FDA Acceptance of lorundrostat NDA
The FDA has accepted the New Drug Application for lorundrostat, assigning a December 22, 2026 PDUFA target date. The submission included data from five positive clinical trials demonstrating clinically meaningful blood pressure reductions, 24-hour control and a favorable safety profile in adults with resistant hypertension.
2. Pre-Commercial Activities
Mineralys is advancing market access discussions, expanding medical advocacy and preparing sales and marketing programs to support a successful launch of lorundrostat. An open-label extension trial continues to generate long-term safety and efficacy data to bolster the product profile prior to approval.
3. First Quarter 2026 Financial Results
For the quarter ended March 31, 2026, the company reported $646.1 million in cash, cash equivalents and investments, compared to $656.6 million at year-end 2025. R&D expenses were $24.4 million, G&A expenses were $21.0 million, and net loss totaled $39.3 million.
4. Cash Runway and Outlook
With current cash and investments, the company expects to fund planned clinical trials, regulatory activities and corporate operations into 2028. The focus remains on advancing lorundrostat toward potential approval and maintaining strategic flexibility for future growth opportunities.
