#MLYS

Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results Mineralys Therapeutics (NASDAQ: MLYS) announced FDA acceptance of the NDA for lorundrostat for treatment of adults with hypertension in combination with other antihypertensives, with a PDUFA target action date of December 22, 2026. Topline Phase 2 Explore-OSA results: lorundrostat did not reduce AHI (primary endpoint) but produced clinically meaningful blood pressure reductions (11.1 mmHg vs baseline; 6.2 mmHg placebo-adjusted) after four weeks and showed a favorable safety profile with no serum potassium >5.5 mmol/L.

5 days ago

#MLYS Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results

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Mineralys Therapeutics to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on Thursday, March 12, 2026 Mineralys Therapeutics (Nasdaq: MLYS) will report fourth quarter and full year 2025 financial results after market close on Thursday, March 12, 2026.The company will host a conference call and live webcast at 4:30 p.m. ET on that date; dial-in numbers, conference ID 13758574, and a webcast link will be available on the Investor Relations News & Events page.

6 days ago

#MLYS Mineralys Therapeutics to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on Thursday, March 12, 2026

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2 months ago

Mineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026

Today we issued a corporate update highlighting several recent and upcoming clinical & regulatory milestones. Mineralys' management team will also participate in the LifeSci Partners Corporate Access event taking place January 12-14 in San Francisco.

ir.mineralystx.com/news-events/...

#HTN #MLYS

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Mineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026 Mineralys Therapeutics (Nasdaq: MLYS) issued a corporate update announcing clinical and regulatory milestones for lorundrostat, its investigational antihypertensive.Key points: the company filed an NDA in late 2025 after completing three positive clinical trials in 2025; two global pivotal Phase 3 trials met primary endpoints; the Phase 2 Explore-CKD trial met its primary systolic blood pressure endpoint and reduced proteinuria; enrollment for Explore-OSA finished in Q3 2025 with topline results expected in Q1 2026. An open-label extension continues to collect long-term safety and efficacy data.

2 months ago

#MLYS Mineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026

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2 months ago

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Mineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup Mineralys Therapeutics (Nasdaq: MLYS) reported that its Phase 3 Launch-HTN trial of lorundrostat was selected in JAMA’s inaugural “Research of the Year Roundup” on Dec 12, 2025.The 1,083-participant trial showed lorundrostat 50 mg once daily produced mean automated office systolic BP reductions of 16.9 mmHg at Week 6 (placebo-adjusted −9.1 mmHg, p<0.0001) and 19.0 mmHg at Week 12 (placebo-adjusted −11.7 mmHg, p<0.0001), with a diverse enrolled population and discontinuation rates <1%.Safety signals included higher rates of hyponatremia, hyperkalemia, and reduced kidney function in the treatment arm. Ongoing trials include Transform-HTN and Explore-OSA with data expected Q1 2026.

3 months ago

#MLYS Mineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup

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Nasdaq

@nasdaq.activitypub.awakari.com.ap.brid.gy

3 months ago

This Fund Leaned Into 2025's Big Biotech Rally with a $9.5 Million Bet on Mineralys | The Motley Fool One small fund’s high-conviction move offers a window into how specialists are navigating 2025’s biotech rally.

#MLYS #9a259fcd-18c5-4a41-97d7-216fe7428647 #coveragefilings

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Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update Mineralys Therapeutics (Nasdaq: MLYS) reported Q3 2025 results and a corporate update on Nov 10, 2025. Key clinical milestones include a planned NDA submission for lorundrostat in late‑2025 or Q1 2026 and completed enrollment in the Explore‑OSA Phase 2 trial with topline data expected Q1 2026.Financial highlights: $593.6M cash, cash equivalents and investments as of Sep 30, 2025 (vs. $198.2M at Dec 31, 2024), and a completed public equity financing raising approximately $287.5M gross on Sep 4, 2025. Q3 net loss was $36.9M; R&D expense was $31.5M (Q3 2024: $54.0M). Management expects cash to fund operations into 2028.

4 months ago

#MLYS Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

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Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025 Mineralys Therapeutics (Nasdaq: MLYS) reported clinical data for lorundrostat at ASN Kidney Week 2025, including a late-breaking Phase 2 Explore-CKD presentation and recognition of the Phase 3 Launch-HTN trial in the “Best of JAMA and NEJM” session.Explore-CKD (lorundrostat 25 mg QD added to standard care) met its primary endpoint at week 4: AOSBP -9.3 mmHg (placebo-adjusted -7.5 mmHg, p=0.0024) and UACR -25.6% placebo-adjusted (p=0.0015). Launch-HTN showed SBP reductions up to 19 mmHg (11.6 mmHg placebo-adjusted at week 12, p<0.0001). Safety: SAEs occurred in 3% on lorundrostat vs 0% placebo; discontinuations 3% vs 2%. The company plans an NDA filing in Q4 2025 or Q1 2026.

4 months ago

#MLYS Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025

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4 months ago

PRESS RELEASE Mineralys Therapeutics Announces Late-Breaking Presentation of Phase 2 Explore-CKD Trial of Lorundrostat at American Society of Nephrology (ASN) Kidney Week 2025

We will be presenting lorundrostat data from our Phase 2 Explore-CKD trial in a late-breaking session next month at @asnkidney.bsky.social #KidneyWk on Friday, November 7.

Read our press release for details: ir.mineralystx.com/news-events/...

#Hypertension #CKD #ClinicalData #MLYS

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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 Trial of lorundrostat to be included in “Best of Journal of the American Medical Association and the

4 months ago

#MLYS Mineralys Therapeutics Announces Late-Breaking Presentation of Phase 2 Explore-CKD Trial of Lorundrostat at American Society of Nephrology (ASN) Kidney Week 2025

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Can a new class of drugs finally control hypertension in millions of patients? In this Q&A, Mineralys CEO Jon Congleton discusses how targeting aldosterone could reshape hypertension treatment. Aldosterone synthase inhibitors

5 months ago

Our CEO spoke with @statnews.com about recent breakthroughs in understanding cardiovascular diseases and how targeting aldosterone could reshape #hypertension treatment.

Read the Q&A here: www.statnews.com/sponsor/2025...

#HighBloodPressure #CVD #CardioRenalMetabolic #MLYS

#CardioSky #NephSky

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@nasdaq.activitypub.awakari.com.ap.brid.gy

5 months ago

"Our vision is to lead in targeted therapies for aldosterone-driven cardio-renal-metabolic (CRM) disease. By targeting aldosterone dysregulation, we aim to meet a critical unmet need with a new mechanism in a field that has seen little innovation in over two decades." -Jon Congleton CEO of Mineralys Therapeutics

In just 6 years, Mineralys advanced #lorundrostat, a potential first-in-class aldosterone synthase inhibitor, from concept to pivotal published trials in #hypertension and is now preparing for a pre-NDA meeting in Q4 2025.

Learn more: www.thepharmaletter.com/pharmaceutic...

#Innovation #MLYS

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Market Wire News

@marketwirenews.com

6 months ago

Just In: ( NASDAQ: #MLYS ) These 2 Healthcare Stocks More Than Doubled Recently and Could Soar Higher, According to Wall Street Analysts

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Nasdaq

6 months ago

#PGEN #AZN #MLYS #082d9db2-09a3-4de9-8906-575b6bed1a96 #investing

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Market Wire News

@marketwirenews.com

6 months ago

Just In: ( NASDAQ: #MLYS ) 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

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Mineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common Stock Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other

6 months ago

#MLYS Mineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common Stock

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Small Cap Strategist

@smcapstrategist.bsky.social

6 months ago

Leading Indicators, Tuesday September 2, 2025 – Crystal Equity Research

Small-cap stocks gapping up in trading, Tue Sept 2nd - #UUU #ITRG #GROY #CARV #ULCC #SHFS #MNKD #MLYS #CARM #TIXT #MUX - More: crystalequityresearch.com/leading-indi... - #smallcap

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Market Wire News

@marketwirenews.com

6 months ago

JUST IN: ( NASDAQ: #MLYS ) Lasers, Lungs & Leapfrogs: Innovation Sparks Market Moves as Healthcare Stocks Surge

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$175 Million Stock Offering: Mineralys Therapeutics Seeks Funding for Hypertension Drug Development Biotech firm Mineralys Therapeutics announces $175M common stock offering with $26.25M additional option. Proceeds to fund lorundrostat clinical development for hypertension and CKD treatment.

6 months ago

#MLYS Mineralys Therapeutics Announces Proposed Public Offering of Common Stock

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Mineralys' Hypertension Drug Shows Promise in Multiple Studies, Heads Toward FDA Filing Drug candidate lorundrostat achieved key endpoints in treating resistant hypertension, with data published in JAMA and NEJM. Company plans FDA pre-NDA meeting for Q4 2025. Learn more.

7 months ago

#MLYS Mineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update

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8 months ago

PRESS RELEASE: Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat

Detailed results from the pivotal P3 Launch-HTN trial were published today in @jama.com, reinforcing lorundrostat’s efficacy in a real-world setting.

Read our press release to learn more: ir.mineralystx.com/news-events/...

#BloodPressure #Cardiology #Cardiosky #MLYS

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Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat Mineralys Therapeutics (NASDAQ: MLYS) has published positive results from its pivotal Phase 3 Launch-HTN trial for lorundrostat in the Journal of the American Medical Association (JAMA). The trial, which is the largest study of an aldosterone synthase inhibitor in patients with uncontrolled or treatment-resistant hypertension, enrolled 1,083 participants.The study demonstrated that lorundrostat 50 mg once daily achieved significant blood pressure reductions: 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted; p-value 19.0 mmHg reduction at Week 12 (-11.7 mmHg placebo adjusted; p-value The drug showed a favorable safety profile with mostly mild, transient adverse events. Only 0.6% of patients on lorundrostat experienced elevated potassium levels above 6.0 mmol/L, compared to 0.4% in the placebo group. The trial included patients on two to five existing antihypertensive medications and utilized automated office blood pressure measurements to reflect real-world clinical settings.

8 months ago

#MLYS Mineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat

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