Mineralys Therapeutics Reports Fourth Quarter and Full Year 2025 Financial Results and Provides Corporate Update
Today we reported financial results for the fourth quarter and full year ending December 31, 2025, and provided a corporate update.
Learn more: ir.mineralystx.com/news-events/...
#Hypertension #ChronicKidneyDisease $MLYS
Mineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for the Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results
The U.S. FDA has accepted our NDA for lorundrostat for the treatment of adult patients with other antihypertensive drugs and set a PDUFA date of Dec. 22. Also announced were topline results from the P2 Explore-OSA exploratory trial.
Details here: ir.mineralystx.com/news-events/...
#Hypertension
Graphic with headline: The Heart is central to Cardiometabolic Health Image shows center circle with the world Aldosterone and 6 circles around it including (clockwise): Obese Uncontrolled Hypertension Treatment Resistant Hypertension Chronic Kidney Disease Vascular & Systemic Inflammation HFpEF & HFrEF Obstructive Sleep Apnea
As American Heart Month wraps up, itβs worth remembering that heart health is bigger than the heart alone. Mineralys Therapeutics is taking a targeted approach to hypertension and cardio-renal-metabolic disease by addressing a key driver, aldosterone.
#CRM #HeartHealth #HeartMonth
Cardiovascular Professionals Week February 8-15, 2026 Image of a stethoscope and heart.
In February we honor #HeartMonth, as well as #CardiovascularProfessionalsWeek. Mineralys celebrates the dedicated individuals working tirelessly on the prevention, diagnosis, treatment and rehabilitation of heart and vascular diseases.
February is American #HeartMonth β€οΈ
Despite the availability of effective therapies for #hypertension, treatment and control rates have stalled and related CV death rates in the U.S. have nearly doubled in 20 years.
At Mineralys, weβre advancing science to change this trajectory.
#KnowYourNumbers
"Overall, we believe aldosterone synthase inhibition has the potential to be one of the most transformative advances in cardiovascular medicine in decades - and we're just getting started." -Jon Congleton CEO of Mineralys Therapeurics with headshot photograph
Our CEO spoke with @firstwordgroup.com about how Mineralys is reviving innovation in #hypertension by targeting aldosterone, what differentiates the companyβs approach, and where lorundrostat could play a role in cardiorenal & metabolic disease.
Read the interview: firstwordpharma.com/story/7067623
At Mineralys, we are advancing lorundrostat, a highly selective aldosterone synthase inhibitor, designed to directly target aldosterone production and explore a more precise approach to blood pressure biology.
#Hypertension #Obesity #CardiometabolicHealth #Aldosterone #BloodPressure
The link between obesity, aldosterone and hypertension
This week is the @americanheart.bsky.social's
#HealthyWeightWeek. #Obesity & #hypertension often coexist, and dysregulated aldosterone is frequently observed in patients with uncontrolled or treatment-resistant hypertension and in patients with obesity.
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
2025 was an exciting year for Mineralys! We are grateful to everyone who contributed to our journey to advance Lorundrostatβs development in #HTN, #CKD and #OSA.
Our P3 Launch-HTN trial of lorundrostat - the largest trial of an aldosterone synthase inhibitor conducted among participants with uncontrolled or treatment-resistant hypertension - was featured in JAMAβs inaugural βResearch of the Yearβ article!
ir.mineralystx.com/news-events/...
#JAMAROTY25
In addition, our pivotal Phase 3 Launch-HTN trial was featured in the βBest of the Journal of the American Medical Association (JAMA) and the New England Journal of Medicine (NEJM)β session.
@asnkidney.bsky.social
@jama.com
#Hypertension #CKD #CardioRenalMetabolic
#NephSky #CardioSky
PRESS RELEASE Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025
We shared data from the P2 Explore-CKD trial during a late-breaking oral presentation at #KidneyWk. The parallel reductions in systolic blood pressure & albuminuria underscore lorundrostat's potential to improve cardio-renal outcomes in this high-risk population. ir.mineralystx.com/news-events/...
AHA Scientific Sessions November 8-10 | New Orleans, LA Booth 4216
Dysregulated Aldosterone in Uncontrolled Hypertension: The Overlooked Risk Factor and New Therapeutic Options Saturday, November 8, 2025 9:30 AM - 10:15 AM in Heart Theater 1 Unmet Need in Uncontrolled and Resistant Hypertension Michael Bloch, MD Clinical Associate Professor and Medical Director, University of Nevada/Reno School of Medicine, Renown Institute for Heart and Vascular Health Role of Aldosterone Dysregulation and Impact on Hypertension and Beyond Jorge Plutzky, MD Director, Preventive Cardiology Harvard Medical School Cardiovascular Medicine Efficacy & Safety of Novel ASI, Lorundrostat from Launch-HTN study Manish Saxena, MBBS Clinical Director, Barts Health NHS Trust & Queen Mary University London, UK
If youβre attending #AHA25, stop by & connect with our Medical Affairs team to learn more about our focus on aldosterone biology in CRM diseases.
πBooth #4216
And join us Saturday in Heart Theater 1 for a discussion on the unmet need in uncontrolled #hypertension.
We hope to see you!
Best of JAMA & NEJM JAMA: Lorundrostat in Participants with Uncontrolled Hypertension and Treatment-Resistant Hypertension - The Launch-HTN Randomized Clinical Trial PRESENTER: Manish Saxena, MBBS, MSc November 7th | 2:00 PM to 2:20 PM CST Grand Ballroom A, Convention Center
Data from the Phase 3 Launch-HTN trial of lorundrostat will be featured during a session tomorrow highlighting the most impactful #kidney research articles recently published in @jama.com & @nejm.org.
#NephSky #CardioSky
LATE-BREAKING RESEARCH Lorundrostat, a Novel Aldosterone Synthase Inhibitor (ASI), in Participants with Uncontrolled Hypertension, CDK, and Albuminuria: Results from Explore-CKD November 7th | 5:06 PM to 5:18 PM CST Grand Ballroom C, Convention Center
If youβre in #Houston for @asnkidney.bsky.social #KidneyWk, join us tomorrow in Grand Ballroom C at the Convention Center to catch our #latebreaking presentation.
We hope to see you there!
#Hypertension #CKD #KidneyCare
"Mineralys' singular focus on aldosterone biology and its nimble, patient-driven culture position it as a company determined not just to participate in this shift, but to lead it" -Jon Congleton CEO of Mineralys Therapeutics
#Hypertension remains the leading modifiable risk factor for #CVD, despite decades of therapeutic efforts. Aldosterone dysregulation is increasingly recognized as a missing piece of the puzzle.
Read: www.statnews.com/sponsor/2025...
#CardioSky #NephSky
Our team was in #Detroit with Black Girls RUN! & Dr. John Flack who discussed health equity and how black women can prioritize healthy living.
Mineralys is focused on improving outcomes for people with #hypertension, including high-risk populations, and was honored to be part of this event.
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
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
Mineralys Therapeutics Completes Enrollment in Phase 2 Explore-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
Today we announced completion of enrollment in Explore-OSA, our Phase 2 #clinicaltrial examining the efficacy, safety & tolerability of lorundrostat in participants with #OSA & #hypertension. Topline results are anticipated in Q1 2026.
Read: ir.mineralystx.com/news-events/...
#CardioSky #NephSky
Hypertension or high blood pressure affects 1.4B people globally. Itβs the most prevalent & modiο¬able risk factor of cardiovascular diseases. In the U.S., 70M+ people aged 30β79 years have uncontrolled #hypertension.
#WorldHeartDay #HighBloodPressure β₯οΈ
Text reads: β7 in 10 people living with hypertension do not have it under control. Get your blood pressure checked today.β
New WHO report finds 1.4 billion people live with #hypertension.
Hypertension is the number one risk factor for:
βΌοΈ Heart attack
βΌοΈ Stroke
and can lead to:
βΌοΈ Chronic kidney disease
βΌοΈ Dementia
Get your blood pressure checked today! Learn more π bit.ly/4nikP8v
"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
#HighBloodPressure #CKD #OSA #CardioSky #NephSky
Our CEO spoke with ThePharmaLetter about Mineralysβ clarity of purpose, long-term vision, & the clinical opportunities for lorundrostat to treat #hypertension and other aldosterone-driven conditions.
Read the interview: www.thepharmaletter.com/pharmaceutic...
#CardiovascularDisease
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Patients with High Unmet Medical Need
Dr. Manish Saxena is presenting new subgroup analyses from our Launch-HTN trial of lorundrostat at the American Heart Association Hypertension Scientific Sessions.
Details: ir.mineralystx.com/news-events/...
#Hypertension25 #BloodPressure @ahascience.bsky.social
#HighBloodPressure #CardiovascularDisease #CKD #OSA #CardioSky #NephSky
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
Today we closed the sale of additional stock shares in our underwritten public offering, bringing total gross proceeds to $287.5M. Funds will support clinical development of lorundrostat, R&D and manufacturing, & pre-commercial activities.
Read: ir.mineralystx.com/news-events/...
#Hypertension
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