Mineralys Therapeutics reports Q3 EPS (52c), consensus (61c)

“We are at an exciting point in our company’s history as we prepare for our NDA submission following pre-NDA feedback from the FDA last month. Our team has developed a fulsome data package consisting of multiple clinical trials which have demonstrated a well characterized efficacy and safety profile across distinct populations with uncontrolled and resistant hypertension. These findings for lorundrostat will provide the foundation for an NDA submission which we anticipate submitting near the end of 2025 or during the first quarter of 2026,” stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics (MLYS). “We continue to evaluate lorundrostat’s use in prevalent comorbidities of hypertension, for which normalizing aldosterone production may result in meaningful clinical benefit. Following positive topline data from our Phase 2 Explore-CKD trial, demonstrating successful results in the OSA patient population in our Phase 2 Explore-OSA trial would continue to expand the opportunity for lorundrostat in treating hypertension patients.”