Earnings summaries and quarterly performance for Mineralys Therapeutics.
Executive leadership at Mineralys Therapeutics.
Board of directors at Mineralys Therapeutics.
Research analysts who have asked questions during Mineralys Therapeutics earnings calls.
Michael DiFiore
Evercore ISI
4 questions for MLYS
Also covers: ALT, AMGN, AMLX +11 more
Rami Katkhuda
LifeSci Capital
4 questions for MLYS
Also covers: AMLX, ELDN, VRDN
JL
Jin Law
Goldman Sachs
3 questions for MLYS
Also covers: SLN
MC
Matthew Caufield
H.C. Wainwright & Co., LLC
3 questions for MLYS
Also covers: DMAC, OPTN, PHAT +1 more
Annabel Samimy
Stifel Financial Corp.
2 questions for MLYS
Also covers: ALT, APLS, CARA +14 more
Mohit Bansal
Wells Fargo & Company
2 questions for MLYS
Also covers: ABBV, AMGN, BMRN +16 more
SF
Seamus Fernandez
Guggenheim Partners
2 questions for MLYS
Also covers: AMLX, ARCT, ARQT +9 more
A
Alice
Bank of America
1 question for MLYS
Also covers: ALKS
AN
Alice Nettleton
Bank of America
1 question for MLYS
CG
Colleen Garvey
Guggenheim Securities
1 question for MLYS
Also covers: SNY
DD
Dennis Ding
Jefferies Financial Group Inc.
1 question for MLYS
Also covers: ARDX, CARA, CRNX +10 more
JM
Jayed Momin
Stifel Financial Corp.
1 question for MLYS
Also covers: ALT, APLS
RL
Richard Law
Goldman Sachs
1 question for MLYS
Also covers: ARQT, CRNX
SR
Sadia Rahman
Wells Fargo
1 question for MLYS
Also covers: AMGN, HALO, TVTX
Recent press releases and 8-K filings for MLYS.
Mineralys Therapeutics' Lorundrostat NDA Accepted by FDA; Explore-OSA Trial Results Announced
MLYS
Product Launch
New Projects/Investments
- Mineralys Therapeutics announced the FDA's acceptance of its New Drug Application (NDA) for lorundrostat for the treatment of adult patients with hypertension in combination with other antihypertensive drugs.
- The FDA has set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026, for lorundrostat.
- Topline results from the Phase 2 Explore-OSA exploratory trial indicated that lorundrostat did not achieve a clinically meaningful reduction in the apnea-hypopnea index (AHI), the primary endpoint.
- However, the Explore-OSA trial demonstrated a clinically meaningful reduction in blood pressure, with an 11.1 mmHg BP reduction for lorundrostat versus 1.0 mmHg for placebo, and a 6.2 mmHg placebo-adjusted reduction in BP, along with a favorable safety profile.
2 days ago
Mineralys Therapeutics Files NDA for Lorundrostat and Anticipates Q1 2026 Trial Results
MLYS
Product Launch
New Projects/Investments
- Mineralys Therapeutics, Inc. (MLYS) filed a New Drug Application (NDA) for lorundrostat with the U.S. Food and Drug Administration (FDA) in late 2025, following the completion of three positive clinical trials.
- The company expects to report topline results from the Phase 2 Explore-OSA trial in the first quarter of 2026.
- Lorundrostat has demonstrated a "best-in-class profile" with clinically meaningful blood pressure reduction, 24-hour control, and a favorable safety and tolerability profile across various patient populations, supported by positive results from the Explore-CKD, Launch-HTN, and Advance-HTN trials.
Jan 6, 2026, 1:05 PM
Mineralys Therapeutics Files NDA for Lorundrostat and Anticipates Q1 2026 Trial Results
MLYS
Product Launch
New Projects/Investments
- Mineralys Therapeutics filed a New Drug Application (NDA) for lorundrostat with the U.S. FDA in late 2025, following the completion of three positive clinical trials in 2025 that demonstrated best-in-class safety and 24-hour blood pressure control.
- The company announced positive data from the Phase 2 Explore-CKD trial, which met its primary endpoint on systolic blood pressure reduction and showed meaningful reduction in proteinuria.
- Mineralys remains on track to report topline results from the Phase 2 Explore-OSA trial in the first quarter of 2026.
- Management will participate in the 15th LifeSci Partners Corporate Access event taking place January 12-14, 2026, in San Francisco, California.
Jan 6, 2026, 1:00 PM
Mineralys Therapeutics Provides Update on Lorundrostat NDA Filing, Launch Timeline, and Financial Position
MLYS
Product Launch
Guidance Update
New Projects/Investments
- Mineralys Therapeutics (MLYS) anticipates filing its New Drug Application (NDA) for lorundrostat by the end of 2025 or Q1 2026, incorporating data from the Advance-HTN, Launch-HTN, and Explore-CKD studies.
- The potential launch of lorundrostat is projected for late 2026 to Q1 2027, assuming a smooth process with the FDA.
- The company reported $594 million in cash at the end of Q3, which is expected to fund pre-commercialization work, clinical trials, NDA submission, and launch into 2027, with cash extending into 2028 in the absence of a partner.
- MLYS plans to target approximately 60,000 doctors who drive 50% of prescriptions for third-line or later resistant hypertension, estimating this could be achieved with about 400 sales representatives for the U.S. launch.
- Top-line data from the Explore OSA (obstructive sleep apnea) study is expected to read out in Q1 2026.
Dec 3, 2025, 8:25 PM
Mineralys Therapeutics Provides Update on Lorundrostat NDA Filing, Commercialization, and Financial Outlook
MLYS
Guidance Update
Product Launch
New Projects/Investments
- Mineralys Therapeutics expects to file its New Drug Application (NDA) for lorundrostat by the end of 2025 or Q1 2026, following positive data readouts in 2025 from pivotal studies including Advance-HTN, Launch-HTN, and Explore-CKD, which demonstrated significant reductions in blood pressure and proteinuria.
- The company anticipates a commercial launch of lorundrostat between late 2026 and Q1 2027, targeting an estimated 20 million patients in the US with uncontrolled hypertension.
- Mineralys plans to reach key prescribing physicians with an estimated 400 sales representatives, complemented by non-personal promotion strategies.
- As of the end of Q3, Mineralys had $594 million in cash on hand, which is projected to fund the company through the launch in 2027 and extend into 2028.
- Top-line data from the Explore OSA trial for obstructive sleep apnea is expected in Q1 2026.
Dec 3, 2025, 8:25 PM
Mineralys Therapeutics Updates on Lorundrostat NDA, Clinical Data, and Commercialization
MLYS
Product Launch
New Projects/Investments
Guidance Update
- Mineralys Therapeutics anticipates filing its NDA for lorundrostat by the end of 2025 or Q1 2026, based on positive data from pivotal studies Advance-HTN and Launch-HTN, and the Explore-CKD study.
- Lorundrostat demonstrated profound reductions in blood pressure and a well-tolerated safety profile across its clinical program, including a reduction in proteinuria for CKD patients.
- The company expects to launch lorundrostat between late 2026 to Q1 2027 and reported $594 million in cash at the end of Q3 , which is projected to fund operations through launch and into 2028.
- Top-line data from the EXPLORE-OSA trial for obstructive sleep apnea is expected in Q1 2026.
Dec 3, 2025, 8:25 PM
Mineralys Discusses Lorundrostat Clinical Outcomes, Market Opportunity, and Commercial Strategy
MLYS
Product Launch
New Projects/Investments
Guidance Update
- Mineralys's aldosterone synthase inhibitor, lorundrostat, achieved successful clinical outcomes in its pivotal LAUNCH and ADVANCE trials, with an NDA filing approaching.
- The company asserts lorundrostat has a best-in-class profile compared to competitor Baxdrostat, citing superior efficacy (11.6 mmHg placebo-adjusted BP reduction vs. 9.8 mmHg for Baxdrostat in comparable studies) and a more favorable safety profile (8% hyperkalemia >5.5 vs. 11% for Baxdrostat).
- Lorundrostat targets a US market of 20 million patients with resistant (10 million) and uncontrolled (10 million) hypertension, with initial commercial uptake anticipated in the fourth-line resistant hypertension population.
- Mineralys is open to strategic partnerships for commercialization, particularly for global reach, but is also prepared to pursue a go-it-alone strategy to maximize value.
Nov 13, 2025, 7:00 PM
Mineralys Discusses Lorundrostat's Best-in-Class Profile and Commercial Strategy
MLYS
Product Launch
New Projects/Investments
M&A
- Mineralys's lead drug, lorundrostat, an aldosterone synthase inhibitor (ASI), is targeting cardiorenal metabolic disorders, with hypertension as the primary indication.
- Mineralys asserts that lorundrostat has a best-in-class profile compared to Baxdrostat, demonstrating superior efficacy with an absolute blood pressure reduction of 19 mmHg (11.6 mmHg placebo-adjusted) and a more favorable safety profile with a lower incidence of hyperkalemia.
- The initial U.S. target market for lorundrostat is estimated at 20 million patients with resistant or uncontrolled hypertension.
- Mineralys is progressing towards an NDA filing for lorundrostat, having received positive pre-NDA feedback, and is actively exploring partnership opportunities for commercialization.
- The company has also generated positive data in CKD patients, showing a 30% reduction in UACR albuminuria at four weeks, which will inform the label, and has an ongoing study in hypertension with OSA.
Nov 13, 2025, 7:00 PM
Mineralys Provides Update on Lorundrostat Clinical Profile and Commercial Strategy
MLYS
Product Launch
New Projects/Investments
- Mineralys' aldosterone synthase inhibitor (ASI), lorundrostat, has demonstrated a best-in-class clinical profile with superior blood pressure reduction and a more favorable safety profile compared to AstraZeneca's Baxdrostat.
- Lorundrostat exhibits higher selectivity (374:1 for aldosterone relative to cortisol) and an optimized half-life (10-12 hours), contributing to lower rates of hyperkalemia (8% >5.5% and 0.6% >6%) compared to Baxdrostat (11-12% >5.5% and 1.1% >6%).
- The company is targeting a 20 million patient market in the US for resistant and uncontrolled hypertension, with initial commercialization efforts focused on the fourth-line resistant hypertension population.
- Mineralys is preparing for an NDA filing and is actively exploring strategic partnerships for commercialization, while also having the capability to pursue independent market entry.
- Additional clinical data from the EXPLORER CKD study showed a 30% reduction in UACR albuminuria at four weeks, which will inform the label and supports future development in related comorbidities.
Nov 13, 2025, 7:00 PM
Mineralys Therapeutics Discusses Lorundrostat's Market Opportunity and Clinical Profile
MLYS
Product Launch
New Projects/Investments
Revenue Acceleration/Inflection
- Mineralys Therapeutics' CEO Jon Congleton highlighted the significant unmet need in hypertension, noting that 10.8 million lives are lost annually due to related comorbidities and only 20% of treated patients reach blood pressure goals.
- The company's drug, lorundrostat, is an aldosterone synthase inhibitor (ASI) with best-in-class selectivity (374 to 1) for aldosterone over cortisol and an ideal 10 to 12-hour half-life. Clinical trials demonstrated robust blood pressure reductions of 15-19 mmHg, which is transformative compared to typical third or fourth-line agents.
- The U.S. market opportunity for third-line and later hypertension treatment is estimated at 20 million patients, comprising 10 million resistant and 10 million uncontrolled patients. Market research indicates 95% physician intent to prescribe lorundrostat if available.
- Lorundrostat's safety profile, characterized by electrolyte changes, favors it over competitors in terms of hyperkalemia rates.
- Mineralys plans to file lorundrostat by the end of 2025 or Q1 2026, anticipating approval and launch cycles to overlap with competitors.
Nov 11, 2025, 2:30 PM
Quarterly earnings call transcripts for Mineralys Therapeutics.
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