Mineralys Therapeutics Presents New Lorundrostat Data in Participants with Hypertension and Chronic Kidney Disease at ASN Kidney Week 2026
The analysis adds albuminuria findings to blood pressure results while lorundrostat remains under FDA review.
Sentiment and the balance of points
Rhea-AI Sentiment reads the wording of the document, how positive or negative its language is on a 1 to 5 scale. The balance of points shown with the takes weighs what the document actually discloses, so the two can disagree, for example when a trial that missed its main goal is described in upbeat language.
Rhea-AI Summary
Mineralys Therapeutics (MLYS) presented new Phase 3 Launch-HTN data showing lorundrostat reduced blood pressure in participants with and without chronic kidney disease (CKD).
At week 12, placebo-adjusted systolic blood pressure reductions were 9.6 mmHg with CKD and 12.2 mmHg without CKD, both statistically significant. Reductions were consistent across CKD Stages 1–3. Among participants with CKD and baseline albuminuria, or protein in urine, lorundrostat reduced urine albumin-to-creatinine ratio by 52% versus placebo. Confirmed hyperkalemia, or high blood potassium, occurred in 2.4% of CKD participants and 0% without CKD. Lorundrostat is under FDA review for hypertension alongside other blood pressure drugs, with a December 22, 2026 target decision date.
How this balance works
Rhea-AI gives every point it takes from this document a weight. Minor counts 1, Moderate 3 and Major 9, so one Major point outweighs several Minor ones. The bar adds up the weights on each side, and when neither side holds more than 65% of the total the balance reads Mixed.
It reads the document as published, with the same rules for every company, and it does not look at what the market expected or at how the stock traded, so a point can be objectively good on a day the stock falls.
Rhea-AI Sentiment measures something else, the tone of the wording.
Positive
- Minor pointWeek-12 placebo-adjusted systolic blood pressure fell 9.6 mmHg with CKD (p=0.0022) and 12.2 mmHg without CKD (p<0.0001).
- Minor pointBlood pressure reductions were consistent across CKD Stages 1–3 and appeared by week 2 in CKD participants.
- Minor pointWeek-12 systolic pressure below 130 mmHg: lorundrostat versus placebo, 44% versus 18% with CKD; 48% versus 22% without CKD.
- Minor pointUrine albumin-to-creatinine ratio fell 52% versus placebo at week 12 in participants with CKD and baseline albuminuria.
Negative
- Moderate pointHypertension approval remains under FDA review, with a December 22, 2026 target decision date.
- Minor pointConfirmed hyperkalemia, or high blood potassium, occurred in 2.4% of CKD participants and 0% without CKD.
Key Figures
- Placebo-adjusted SBP reduction
- 9.6 mmHg
- CKD participants, week 12; p=0.0022
- Placebo-adjusted SBP reduction
- 12.2 mmHg
- Participants without CKD, week 12; p<0.0001
- Reached target SBP below 130 mmHg
- 44% vs. 18%
- Lorundrostat vs. placebo in CKD participants at week 12
- Reached target SBP below 130 mmHg
- 48% vs. 22%
- Lorundrostat vs. placebo in participants without CKD at week 12
- UACR reduction versus placebo
- 52.2%
- CKD participants with baseline albuminuria at week 12; p<0.0001
- Confirmed hyperkalemia
- 2.4% in CKD participants; 0% without CKD
- Reported safety results
- PDUFA target date
- December 22, 2026
- FDA review of lorundrostat for hypertension in combination with other antihypertensive drugs
Historical Context
-
Launch-HTN update reported 46% reached the recommended systolic blood-pressure target.
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Key Terms
ckd medical
sbp medical
uacr medical
hyperkalemia medical
pdufa regulatory
AI-generated analysis. How Rhea-AI works. Not financial advice.
In the large, pivotal Phase 3 Launch-HTN trial, lorundrostat achieved similar significant blood pressure reductions in participants with and without CKD, with consistent reductions across Stages 1-3 CKD
In participants with CKD, lorundrostat also reduced albuminuria by
RADNOR, Pa., Oct. 22, 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 and other diseases driven by dysregulated aldosterone, today presented new clinical data for lorundrostat at the American Society of Nephrology (ASN) Kidney Week 2026 in Denver, Colorado. The data were shared in an oral presentation delivered by Liffert Vogt, MD, PhD.
In this analysis, lorundrostat provided statistically significant and clinically meaningful reductions in systolic blood pressure (SBP) that were similar between participants with Stages 1 to 3 CKD and those without CKD. At week 12, lorundrostat reduced placebo-adjusted SBP by 9.6 mmHg in participants with CKD (p=0.0022) and 12.2 mmHg in those without CKD (p<0.0001). In participants with CKD, SBP reductions were seen as early as week 2. A greater proportion of lorundrostat-treated participants reached the target SBP below 130 mmHg at week 12 compared with placebo, both among participants with CKD (
Among participants with CKD and baseline albuminuria (protein in the urine, an indicator of kidney damage), lorundrostat reduced urine albumin-to-creatinine ratio (UACR, a way to quantitate the amount of protein in the urine) by
“These results are encouraging. Besides impacting blood pressure in participants with and without kidney disease, treatment with lorundrostat showed a meaningful reduction in albuminuria, a key marker for cardiovascular and kidney risk control,” said Dr. Vogt, Professor of Clinical Nephrology and Renal Physiology at Amsterdam University Medical Center and the University of Amsterdam. “In patients with chronic kidney disease, high blood pressure and albuminuria are two of the most important risk factors we can modify, and lorundrostat improved both in this trial.”
“CKD affects approximately 37 million adults in the U.S., and up to
About Launch-HTN
The Launch-HTN trial (NCT06153693) was a global, randomized, double-blind, placebo-controlled Phase 3 clinical trial of adults whose blood pressure remained uncontrolled despite being on two to five antihypertensive medications. Participants were assigned to one of three groups: lorundrostat 50 mg once daily; lorundrostat 50 mg once daily with the option to increase to 100 mg at week six based on prespecified criteria; or placebo. The primary endpoint was change from baseline in systolic blood pressure at six weeks versus placebo, measured by automated office blood pressure monitoring.
About Hypertension
Having sustained, elevated blood pressure (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 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 blood pressure 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 Lorundrostat
Lorundrostat is an investigational, 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 chronic kidney disease, obstructive sleep apnea 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, has an observed half-life of 10-12 hours and demonstrated a 40
Mineralys has completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program 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 blood pressure 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 chronic kidney disease, obstructive sleep apnea and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is an investigational, 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, X 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 Mineralys’ current beliefs and expectations and include, but are not limited to, statements regarding the anticipated timing of the Food and Drug Administration’s (FDA) review of Mineralys’ accepted new drug application (NDA) and the potential therapeutic benefits of lorundrostat. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Mineralys’ business, including, without limitation: any delays in the FDA’s review of Mineralys’ accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel; the results of Mineralys’ clinical trials, including the Launch-HTN and Advance-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 Mineralys’ NDA submission; the risk that future funding under the secured debt facility may not be available on the timeframe Mineralys expects, or at all, including as a result of its failure to meet the conditions required for such funding or failure to comply with the affirmative and negative covenants under the debt facility; Mineralys may not be able to reach agreement on the proposed termination of its license agreement with Tanabe on its expected timeframe, or at all; Mineralys’ future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; Mineralys’ 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; Mineralys’ ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; Mineralys’ reliance on its exclusive license with Tanabe to provide Mineralys with intellectual property rights to develop and commercialize lorundrostat; and other risks described in Mineralys’ filings with the Securities and Exchange Commission (SEC), including under the heading "Risk Factors" in its 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 Mineralys undertakes 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
FAQ
AI-generated questions and answers. How Rhea-AI works. Not financial advice.
What did Mineralys Therapeutics report about lorundrostat in participants with chronic kidney disease?
At week 12, lorundrostat lowered systolic blood pressure by 9.6 mmHg versus placebo in participants with CKD. Among those with CKD and baseline albuminuria, it also reduced urine albumin-to-creatinine ratio, a measure of protein in urine, by 52% versus placebo.
When is the FDA target decision date for Mineralys Therapeutics' lorundrostat?
The FDA target decision date is December 22, 2026. Lorundrostat is under review for treating hypertension in combination with other antihypertensive drugs; the target date is not an approval.
How many Launch-HTN participants reached the blood pressure target with lorundrostat?
At week 12, 44% of lorundrostat-treated participants with CKD reached systolic blood pressure below 130 mmHg, compared with 18% on placebo. Among participants without CKD, the corresponding proportions were 48% and 22%.