USFDAMay 6, 2026, 04:15 PM
Mineralys FDA Accepts Lorundrostat NDA; PDUFA Dec 22, 2026; Q1 Net Loss $39.3M
AI Summary
Mineralys Therapeutics announced its first quarter 2026 financial results and provided a corporate update. The U.S. FDA accepted the New Drug Application (NDA) for lorundrostat for hypertension, assigning a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026. The company reported a net loss of $39.3 million for the quarter, an improvement from $42.2 million in the prior year. Mineralys is also advancing pre-commercial activities for lorundrostat and expects its current cash, cash equivalents, and investments of $646.1 million to fund operations into 2028.
Key Highlights
- FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.
- Cash, cash equivalents, and investments were $646.1 million as of March 31, 2026.
- Net loss for Q1 2026 was $39.3 million, compared to $42.2 million in Q1 2025.
- Research and development expenses decreased to $24.4 million in Q1 2026 from $37.9 million in Q1 2025.
- General and administrative expenses increased to $21.0 million in Q1 2026 from $6.6 million in Q1 2025.
- Total other income, net, was $6.0 million in Q1 2026, up from $2.2 million in Q1 2025.
- Company believes current cash will fund operations into 2028.