NasdaqGS:MLYSBiotechs
How Investors Are Reacting To Mineralys Therapeutics (MLYS) FDA Acceptance Of Lorundrostat Hypertension NDA
Mineralys Therapeutics recently reported that the FDA accepted its New Drug Application for lorundrostat for adults with hypertension, setting a PDUFA target action date of December 22, 2026, based on multiple trials showing blood pressure reductions and a favorable safety profile.
Although the Phase 2 Explore-OSA study did not improve sleep apnea severity, its blood pressure benefit in a difficult-to-treat, obese hypertensive population highlights lorundrostat’s potential relevance across...