Mineralys Therapeutics Inc
NASDAQ:MLYS
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Mineralys Therapeutics Inc
NASDAQ:MLYS
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Mineralys Therapeutics Inc
Mineralys Therapeutics, Inc. s a clinical-stage biopharmaceutical company engages in developing medicines to target disease, driven by abnormally elevated aldosterone. The company is headquartered in Radnor, Pennsylvania and currently employs 12 full-time employees. The company went IPO on 2023-02-10. The firm is focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is initially developing for the treatment of patients with uncontrolled hypertension (uHTN). The firm completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uHTN. The company intends to develop lorundrostat for the treatment of chronic kidney disease (CKD).
Mineralys Therapeutics, Inc. s a clinical-stage biopharmaceutical company engages in developing medicines to target disease, driven by abnormally elevated aldosterone. The company is headquartered in Radnor, Pennsylvania and currently employs 12 full-time employees. The company went IPO on 2023-02-10. The firm is focused on developing medicines to target diseases driven by abnormally elevated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is initially developing for the treatment of patients with uncontrolled hypertension (uHTN). The firm completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uHTN. The company intends to develop lorundrostat for the treatment of chronic kidney disease (CKD).
NDA/PDUFA: The FDA accepted the NDA for lorundrostat and set a PDUFA target action date of December 22, 2026.
Clinical strength: Management emphasized five positive trials supporting durable, 24-hour blood pressure control and a favorable safety profile for lorundrostat in uncontrolled/resistant hypertension.
Explore-OSA: In a 48-patient, 4-week trial (avg BMI 38, AHI 48, baseline SBP 142 mmHg) lorundrostat produced an 11.1 mmHg SBP drop vs 1.0 mmHg for placebo at 4 weeks (6.2 mmHg placebo-adjusted in crossover), but did not meet the primary AHI endpoint; safety was favorable with no K+ > 5.5 mmol/L.
Payer/prelaunch: Company reports constructive payer engagement focused on third-line/later (resistant) hypertension access and is expanding medical affairs and MSL coverage to support uptake.
Cash/runway: Cash, cash equivalents and investments were $656.6 million as of December 31, 2025, which management says is sufficient to fund operations into 2028.
Cost trends: R&D spend declined in 2025 as pivotal work wound down; annual R&D $132.0M (2025) vs $168.6M (2024), and net loss narrowed to $154.7M (2025) from $177.8M (2024).
Partnership strategy: Management is actively engaging potential partners to maximize commercial and ex-U.S. value while continuing prelaunch commercial preparations in case a partner is not in place by approval.
