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Mineralys Therapeutics (MLYS) investor relations material
Mineralys Therapeutics Evercore ISI 8th Annual HealthCONx Conference summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.Evercore ISI 8th Annual HealthCONx Conference summary3 Dec, 2025
Business and clinical development update
Three major data readouts in 2023–2024 demonstrated significant blood pressure reduction and safety in pivotal studies, supporting NDA preparation.
Additional data from Explore-CKD showed benefits in patients with hypertension and proteinuria, expanding the clinical profile.
Lorundrostat targets a large population of patients with uncontrolled hypertension, with a focus on best-in-class efficacy and safety.
NDA submission is planned by end of 2024 or Q1 2025, with all key studies included.
No remaining gating factors for NDA; long-term safety data and open-label extension are well characterized.
Commercial readiness and launch planning
Manufacturing and commercial scale preparations are complete, with all sites audited and ready for inspection.
Targeting 60,000 high-prescribing doctors, mainly primary care and cardiologists, with an estimated 400 sales reps for optimal coverage.
Exploring efficient omnichannel and non-personal promotion strategies to augment sales force.
Current cash position ($594M as of Q3) supports pre-commercialization, NDA, and launch through 2027, with cash runway into 2028.
Launch expected between late 2026 and Q1 2027, pending FDA review.
Competitive landscape and market strategy
Ongoing evaluation of promotional spend and go-to-market model, with attention to competitor AstraZeneca's anticipated launch.
Early 2026 focus on medical communications and payer engagement to build awareness and access ahead of competitor launch.
Confident in ability to secure contracts and formulary access despite a potential six-to-nine month lag behind competitor.
Lorundrostat's clinical program features robust efficacy, safety, and diversity, distinguishing it from competitors.
What is the status of 52-week OLE data for NDA?
How will Mineralys secure formulary access?
What is the path to profitability post-launch?
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Next Mineralys Therapeutics earnings date
Q4 202517 Mar, 2026
Next Mineralys Therapeutics earnings date
Q4 202517 Mar, 2026
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Frequently asked questions
Mineralys Therapeutics Inc. (MLYS) is a clinical-stage biopharmaceutical company developing treatments for diseases associated with abnormally elevated aldosterone levels. The company's flagship product candidate, lorundrostat, is a highly selective aldosterone synthase inhibitor, currently under investigation for its potential in treating hypertension. The company is headquartered in Radnor, Pennsylvania, and its shares are listed on the Nasdaq.
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