Mineralys Therapeutics Provides Corporate Update and Announces Participation in LifeSci Partners Corporate Access Event
Source: GlobeNewsWire
Company Overview
Mineralys Therapeutics, Inc. (NASDAQ: MLYS), based in Radnor, Pennsylvania, is a clinical-stage biopharmaceutical company devoted to developing innovative therapies targeting hypertension and related comorbidities, including chronic kidney disease (CKD) and obstructive sleep apnea (OSA). Today, the company issued a significant corporate update, outlining key clinical and regulatory milestones achieved and upcoming events.
Upcoming Event Participation
Mineralys Therapeutics has confirmed its management team's participation in the 15th LifeSci Partners Corporate Access event from January 12-14, 2026, in San Francisco, California. This event will provide an opportunity for the company to engage with investors and stakeholders, further highlighting the progress and potential of its leading drug candidate, lorundrostat.
Recent Clinical Highlights and Achievements
The company's CEO, Jon Congleton, expressed confidence in lorundrostat, stating, “As we reflect on the data generated with lorundrostat to date, we are more confident than ever of the drug candidate’s best-in-class profile, based on the clinically meaningful blood pressure reduction, the demonstrated 24-hour control, and its safety and tolerability profile.” The following key milestones have been identified:
- Explore-OSA Phase 2 Trial: Topline results from the Phase 2 trial are expected in Q1 2026, assessing lorundrostat's benefits in patients with hypertension and moderate to severe OSA.
- New Drug Application (NDA): An NDA for lorundrostat was filed with the FDA in late 2025, supported by three successful clinical trials that showcased its best-in-class safety profile.
- Transform-HTN Open-Label Extension Trial: Ongoing trials provide long-term safety and efficacy data, essential for substantiating the NDA submission.
- Explore-CKD Phase 2 Trial: Recent data indicated significant efficacy in lowering systolic blood pressure among patients with hypertension and reduced kidney function.
- Pivotal Launch-HTN Phase 3 Trial: The trial successfully demonstrated lorundrostat's efficacy and safety for treating uncontrolled hypertension (uHTN) as add-on therapy.
- Pivotal Advance-HTN Trial: This trial confirmed the drug’s efficacy among patients on optimized medications, reaffirming its favorable benefit-risk profile.
About Lorundrostat
Lorundrostat is an innovative orally administered, selective aldosterone synthase inhibitor developed for treating uHTN, rHTN, CKD, and OSA. The drug's mode of action involves inhibition of CYP11B2, leading to significant reductions in aldosterone levels
This promising candidate has exhibited a selectivity 374 times stronger for aldosterone synthesis than for cortisol synthesis and has shown a plasma aldosterone reduction of 40-70% in hypertensive individuals.
About Mineralys Therapeutics
Founded by Catalys Pacific, Mineralys Therapeutics is committed to developing therapies aimed at addressing hypertension and its associated complications. More about their initiatives and the progress of lorundrostat can be found on their official website at mineralystx.com.
Forward-Looking Statements
Mineralys Therapeutics emphasizes that the statements made in this announcement that are not historical facts are forward-looking and based on current expectations regarding the clinical program for lorundrostat. Actual results may vary due to risks and uncertainties inherent in biopharmaceutical development.