Mineralys Therapeutics (MLYS) Surges 27.29% on Regulatory Progress and Phase 3 Results

The share price rose to its highest level since the beginning of this month, with an intraday gain of 6.56% on Nov. 12. The stock has surged 27.29% over three trading days, marking its most significant rally in recent memory as investors bet on regulatory milestones and commercial potential.

Mineralys Therapeutics Inc. (MLYS) is advancing its lead drug candidate, lorundrostat, toward a New Drug Application (NDA) submission for hypertension treatment by late 2025 or early 2026. Positive pre-NDA feedback from the FDA, along with robust Phase 3 trial results showing efficacy in high-risk patient populations, has fueled optimism. The drug’s potential to address unmet needs in chronic kidney disease and obstructive sleep apnea further enhances its market appeal, with commercialization plans already in motion.

The company’s strong cash reserves—$593.6 million as of September 30—underscore its financial stability, though accumulated losses of $424.9 million highlight ongoing R&D costs. While regulatory risks and competitive pressures remain, the narrowing GAAP loss in Q3 and strategic focus on market access planning have bolstered investor confidence. With the NDA timeline in view, the stock’s momentum hinges on FDA approval and successful commercialization execution.