USFDAMay 6, 2026, 04:07 PM
Mineralys NDA for Lorundrostat Accepted by FDA; PDUFA Dec 22, 2026
AI Summary
Mineralys Therapeutics announced that the FDA accepted its New Drug Application (NDA) for lorundrostat for adults with hypertension, assigning a PDUFA target date of December 22, 2026. The company also reported its first quarter 2026 financial results, with cash, cash equivalents, and investments totaling $646.1 million. R&D expenses decreased due to the conclusion of the pivotal program, while G&A expenses rose due to pre-commercial activities, resulting in a net loss of $39.3 million.
Key Highlights
- FDA accepted NDA for lorundrostat for hypertension treatment.
- PDUFA target date for lorundrostat set for December 22, 2026.
- Cash, cash equivalents, and investments were $646.1 million as of March 31, 2026.
- R&D expenses decreased to $24.4 million in Q1 2026 from $37.9 million in Q1 2025.
- G&A expenses increased to $21.0 million in Q1 2026 from $6.6 million in Q1 2025.
- Net loss was $39.3 million in Q1 2026, down from $42.2 million in Q1 2025.
- Current cash is sufficient to fund operations into 2028.