Mineralys Therapeutics, Inc. (MLYS)
| Market Cap | 2.27B +172.5% |
| Revenue (ttm) | n/a |
| Net Income | -154.65M |
| EPS | -2.29 |
| Shares Out | 82.45M |
| PE Ratio | n/a |
| Forward PE | n/a |
| Dividend | n/a |
| Ex-Dividend Date | n/a |
| Volume | 603,762 |
| Open | 28.40 |
| Previous Close | 28.49 |
| Day's Range | 27.26 - 28.97 |
| 52-Week Range | 12.59 - 47.65 |
| Beta | 0.69 |
| Analysts | Strong Buy |
| Price Target | 48.67 (+76.92%) |
| Earnings Date | May 11, 2026 |
About MLYS
Mineralys Therapeutics, Inc., a biopharmaceutical company, develops medicines to target diseases driven by dysregulated aldosterone in the United States. It is developing lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor for the treatment of cardiorenal conditions affected by dysregulated aldosterone, such as hypertension, chronic kidney disease, and obstructive sleep apnea. The company was formerly known as Catalys SC1, Inc. and changed its name to Mineralys Therapeutics, Inc. in May 2020. Minera... [Read more]
Financial Performance
Financial StatementsAnalyst Summary
According to 6 analysts, the average rating for MLYS stock is "Strong Buy." The 12-month stock price target is $48.67, which is an increase of 76.92% from the latest price.
News
Mineralys Therapeutics Appoints Jeffrey A. Munsie as Chief Legal Officer
RADNOR, Pa., March 24, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbiditie...
Mineralys Therapeutics Earnings Call Transcript: Q4 2025
FDA accepted the NDA for lorundrostat, setting a PDUFA date of December 22, 2026. Strong clinical results and a robust cash position support launch preparations, with ongoing payer engagement and expanded medical communications. Net loss narrowed year-over-year as R&D spending declined.
Mineralys Therapeutics Reports Fourth Quarter 2025 Financial Results and Provides Corporate Update
– Announced FDA acceptance of NDA for lorundrostat in adults with hypertension; assigned PDUFA target date of December 22, 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa.
Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results
– The FDA assigned a PDUFA target action date of December 22, 2026 – – The NDA is based on positive data from a successful clinical program demonstrating favorable safety and blood pressure reduction ...
Mineralys Therapeutics to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on Thursday, March 12, 2026
RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbiditie...
Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
RADNOR, Pa., Feb. 26, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relate...
Mineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026
RADNOR, Pa., Jan. 06, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relate...
Mineralys Therapeutics' Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup
– Launch-HTN, the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension, was one of nine studies selected as most impact...
Mineralys Therapeutics Transcript: Evercore ISI 8th Annual HealthCONx Conference
Significant clinical progress was highlighted, with NDA submission for lorundrostat expected by early 2025 and launch targeted for late 2026 to early 2027. Commercial readiness is strong, with a focus on efficient market entry and ongoing partner discussions.
Mineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)
RADNOR, Pa., Nov. 26, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relate...
Mineralys Therapeutics Transcript: Stifel 2025 Healthcare Conference
Lorundrostat has shown robust, best-in-class efficacy and safety in resistant and uncontrolled hypertension, with strong data across diverse populations and a favorable comparison to competitors. Market entry will focus on high-need patients, with expansion supported by ongoing studies and a flexible commercialization approach.
Mineralys Therapeutics Transcript: Guggenheim Securities 2nd Annual Healthcare Innovation Conference
Hypertension remains a major unmet need, with lorundrostat and the ASI class offering significant innovation by targeting dysregulated aldosterone. Clinical data show robust BP reductions and a favorable safety profile, with a large U.S. market opportunity and regulatory filings expected soon.
Mineralys Therapeutics Earnings Call Transcript: Q3 2025
Lorundrostat showed strong, sustained BP reductions in diverse, high-risk populations, with NDA submission expected by early 2026. Financials improved with a lower net loss and a strong cash position to fund operations into 2028. Commercial and partnering strategies are advancing.
Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
– Submission of New Drug Application (NDA) for lorundrostat planned for late-2025/Q1 2026 – – Completed enrollment in Explore-OSA trial; topline results anticipated in Q1 2026 – – Conference call toda...
Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025
– Late-breaking presentation of Explore-CKD trial at ASN Kidney Week – – Pivotal Phase 3 Launch-HTN trial featured in the “Best of JAMA and NEJM” session - RADNOR, Pa., Nov. 07, 2025 (GLOBE NEWSWIRE) ...
Mineralys Therapeutics Announces Late-Breaking Presentation of Phase 2 Explore-CKD Trial of Lorundrostat at American Society of Nephrology (ASN) Kidney Week 2025
~ Late-breaking Phase 2 trial data evaluating the safety and efficacy of 25 mg of lorundrostat in participants with hypertension and comorbid CKD to be presented~ ~ Phase 3 data of the Launch-HTN Tria...
Mineralys Therapeutics Transcript: Stifel Virtual Cardiometabolic Forum
Lorundrostat is advancing toward FDA submission following strong pivotal data in hypertension, with additional trials in CKD and OSA supporting broader use. Initial commercialization will target fourth-line patients, with plans to expand and ongoing partnership discussions to maximize reach.
Mineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
~ Topline results from the EXPLORE-OSA trial are anticipated in 1Q 2026 ~ RADNOR, Pa., Sept. 30, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutica...
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
~Pivotal Launch-HTN trial of novel aldosterone synthase inhibitor lorundrostat enrolled a diverse range of participants with uncontrolled or resistant hypertension~
Mineralys Therapeutics Announces Closing of Upsized $287.5 Million Underwritten Public Offering of Common Stock Including Full Exercise of Underwriters' Option to Purchase Additional Shares
RADNOR, Pa., Sept. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relat...
Bruker, Mineralys Therapeutics And Other Big Stocks Moving Lower In Wednesday's Pre-Market Session
U.S. stock futures were mostly higher this morning, with the Nasdaq futures gaining around 150 points on Wednesday.
Mineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common Stock
RADNOR, Pa., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relat...
Mineralys Therapeutics Announces Proposed Public Offering of Common Stock
RADNOR, Pa., Sept. 02, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and relat...
Mineralys Therapeutics Earnings Call Transcript: Q2 2025
Lorundrostat showed strong efficacy and safety in pivotal hypertension and CKD trials, with high physician interest and a robust financial position supporting operations into 2027. Regulatory milestones are on track, and market research indicates significant unmet need and commercial potential.
Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update
– Presented and published the positive results from both the Launch-HTN and Advance-HTN pivotal trials at scientific meetings and in JAMA and NEJM – – Pre-NDA meeting scheduled to take place in 4Q 202...