Mineralys Therapeutics Announces Presentation of New Data from the Phase 3 Launch-HTN Trial of Lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)
Rhea-AI Summary
Mineralys Therapeutics (Nasdaq: MLYS) will present new Phase 3 Launch-HTN data on lorundrostat in patients with uncontrolled hypertension and chronic kidney disease at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026) in Gdańsk, Poland.
The oral presentation is scheduled for May 30, 2026.
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News Market Reaction – MLYS
In the May 19 session, MLYS declined 1.36%, reflecting a mild negative market reaction. Argus tracked a trough of -13.5% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Dec 12 | Phase 3 recognition | Positive | +2.4% | Launch-HTN Phase 3 data highlighted in JAMA “Research of the Year” roundup. |
| Oct 21 | Phase 2 CKD data | Positive | -1.8% | Late-breaking Explore-CKD Phase 2 and Launch-HTN data presentations at ASN. |
| Sep 30 | OSA enrollment complete | Positive | -3.6% | Completion of enrollment in Phase 2 EXPLORE-OSA hypertension and OSA trial. |
| Sep 05 | Subgroup analyses | Positive | +5.1% | Positive Launch-HTN subgroup analyses showing efficacy and favorable safety profile. |
| Jun 30 | JAMA publication | Positive | -1.3% | JAMA publication of pivotal Launch-HTN Phase 3 results in uncontrolled hypertension. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical-trial headlines have produced mixed reactions, with more divergences than alignments and several positive data updates met with flat or negative moves.
Over the past year, Mineralys has repeatedly highlighted positive lorundrostat Phase 3 Launch-HTN data, including a 1,083-patient pivotal trial, JAMA publication, and subgroup analyses showing significant blood pressure reductions and favorable safety. Additional clinical news has covered CKD and OSA trials and high-profile recognitions like JAMA’s “Research of the Year” roundup. Price reactions to these clinical trial updates have been inconsistent, with both gains and selloffs following broadly positive data.
Key Terms
phase 3 medical
double-blind medical
placebo-controlled medical
chronic kidney disease medical
obstructive sleep apnea medical
aldosterone medical
automated office blood pressure monitoring medical
randomized medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
– Oral presentation highlights efficacy and safety profile of lorundrostat in patients with uncontrolled hypertension and chronic kidney disease –
RADNOR, Pa., May 18, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that new data from its Phase 3 Launch-HTN trial in participants with hypertension and CKD will be featured in an oral presentation at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026), taking place May 28–31, 2026 in Gdańsk, Poland.
Details for the Oral Presentation:
| Abstract Title: | Lorundrostat for Hypertension in CKD: Results from the LAUNCH-HTN Trial |
| Presenter: | Liffert Vogt, MD, PhD, professor, Nephology and Renal Transplantation, Amsterdam UMC and University of Amsterdam, Amsterdam, the Netherlands |
| Session Date/Time: | Saturday, May 30th at 17:15 - 17:30 CEST |
| Session Title: | Clinical Trials. Hot line Session 2 |
| Session Location: | Blue Room |
About Launch-HTN
Launch-HTN (NCT06153693) was a global, randomized Phase 3 double-blind, placebo-controlled trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: placebo; lorundrostat 50 mg once daily; or lorundrostat 50 mg once daily with the option to increase to 100 mg at week six. The primary endpoint was change from baseline in systolic BP at six weeks versus placebo, measured by automated office blood pressure monitoring.
About Chronic Kidney Disease (CKD)
CKD, which is characterized by the gradual loss of kidney function, is estimated to affect more than
Emerging evidence points to dysregulated aldosterone as a key driver of both diseases. Excess aldosterone promotes sodium retention, vascular inflammation and fibrosis, contributing to both uncontrolled BP and kidney injury. Despite the availability of existing therapies, a significant proportion of patients remain uncontrolled or undertreated. Early detection and targeted interventions that address underlying mechanisms, such as aldosterone dysregulation, may offer the potential to slow CKD progression, reduce cardiovascular risk and improve long-term outcomes. Without effective management, CKD can advance to kidney failure, requiring dialysis or transplantation.
About Hypertension
Having sustained, elevated blood pressure (BP) (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about
Less than
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), as well as related comorbidities, such as CKD, OSA and other diseases driven by dysregulated aldosterone. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated a 40
The Company has now completed six late-stage clinical trials of lorundrostat supporting the efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. This includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.
About Mineralys
Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.
Forward-Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the anticipated timing of the U.S. Food and Drug Administration’s (FDA) review of our accepted New Drug Application (NDA) and any subsequent regulatory approval of lorundrostat; and the planned future clinical development of lorundrostat and the timing thereof. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal program will support registration of lorundrostat following the FDA’s review of our NDA submission; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:
Investor Relations
investorrelations@mineralystx.com
Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
