1. Mineralys' trial recognized by JAMA as impactful for hypertension treatment. 2. Lorundrostat shows significant blood pressure reduction in treatment-resistant patients. 3. Study highlights diverse participant demographics, enhancing broader applicability. 4. New treatment option addresses unmet needs in hypertension management. 5. Ongoing trials explore lorundrostat's efficacy in related health conditions.
FAQ
Why Bullish?
Recognition from JAMA can boost investor confidence and attention towards MLYS, similar to other biopharma cases where clinical recognition led to price increases. For instance, when competitors received prominent endorsements, their stock prices saw noticeable upticks.
How important is it?
The recognition by JAMA highlights significant clinical progress for MLYS, indicating potential revenue growth from lorundrostat sales and strong investor interest.
Why Long Term?
The long-term approval and market entry of lorundrostat could position MLYS strongly in the hypertension market, aligning with the drug's innovative approach to treatment-resistant cases. Historical patterns show that successful trials translate to sustained stock growth over time.
Mineralys Therapeutics' Launch-HTN Trial Recognized as a Leading Study of 2025
On December 12, 2025, Mineralys Therapeutics, Inc. (Nasdaq: MLYS), announced that its Phase 3 Launch-HTN clinical trial evaluating lorundrostat for the treatment of uncontrolled or treatment-resistant hypertension has been featured in the inaugural “Research of the Year Roundup” by the Journal of the American Medical Association (JAMA). This recognition underscores the trial's significant contribution to hypertension research and patient care.
Key Highlights of the Launch-HTN Trial
Conducted as the largest study of an aldosterone synthase inhibitor, the Launch-HTN trial demonstrated promising results in a cohort of 1,083 participants diagnosed with hypertension that was either uncontrolled or resistant to treatment. Featured under the title “New Hope for Treatment-Resistant Hypertension,” the study indicated that lorundrostat significantly reduced systolic blood pressure (BP) while maintaining a favorable safety profile.
- Significant Blood Pressure Reduction: At Week 6, participants experienced a 16.9 mmHg reduction in automated office blood pressure (AOBP) versus placebo, which was sustainable, showing a 19.0 mmHg decrease at Week 12.
- Mechanism of Action: Lorundrostat works by inhibiting aldosterone production, which is pivotal in managing hypertension, instead of blocking hormone receptors.
- Diversity in Study Population: The trial successfully recruited a diverse group of participants, including a notable representation of women, Black or African American individuals, and elderly participants.
- Safety and Tolerability: Although some side effects were reported, less than 1% of participants discontinued treatment due to adverse events.
Expert Insights on Hypertension Management
Gregory Curfman, MD, JAMA’s Executive Editor, highlighted the trial's implications for the 40% of patients with uncontrolled hypertension, emphasizing the need for innovative treatments like lorundrostat. This modified approach is crucial as existing therapies have proven insufficient for many patients who face serious cardiovascular risks.
"Lorundrostat opens a new approach to the treatment of uncontrolled hypertension," said Curfman.
Ongoing Research and Future Directions
Following the promising results from the Launch-HTN study, lorundrostat is continuing to undergo evaluation in the Transform-HTN open-label extension trial, focusing on its long-term safety and response durability. Additionally, the company has completed enrollment in the Explore-OSA trial, which is the first study assessing lorundrostat’s efficacy in patients with hypertension and moderate-to-severe obstructive sleep apnea (OSA), with expected data release in early 2026.
About Mineralys Therapeutics and Lorundrostat
Mineralys Therapeutics is a clinical-stage biopharmaceutical company dedicated to addressing hypertension and related comorbidities, including chronic kidney disease (CKD) and OSA. Its lead candidate, lorundrostat, is an oral aldosterone synthase inhibitor designed to effectively lower aldosterone levels by inhibiting the CYP11B2 enzyme. This innovative therapy has shown a remarkable 374-fold selectivity for aldosterone-synthase inhibition compared to cortisol-synthase inhibition, with substantial reductions in plasma aldosterone levels observed in clinical trials.