SCHEDULE 13G/A - Mineralys Therapeutics, Inc. (0001933414) (Subject)

SCHEDULE 13G/A - Mineralys Therapeutics, Inc. (0001933414) (Subject)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

10-Q - Mineralys Therapeutics, Inc. (0001933414) (Filer)

8-K - Mineralys Therapeutics, Inc. (0001933414) (Filer)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

144 - Mineralys Therapeutics, Inc. (0001933414) (Subject)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

4 - Mineralys Therapeutics, Inc. (0001933414) (Issuer)

Jefferies initiated coverage of Mineralys Therapeutics with a rating of Hold and set a new price target of $15.00

H.C. Wainwright initiated coverage of Mineralys Therapeutics with a rating of Buy and set a new price target of $30.00

Goldman initiated coverage of Mineralys Therapeutics with a rating of Buy and set a new price target of $30.00

Evercore ISI initiated coverage of Mineralys Therapeutics with a rating of Outperform

BofA Securities initiated coverage of Mineralys Therapeutics with a rating of Buy and set a new price target of $39.00

Guggenheim initiated coverage of Mineralys Therapeutics with a rating of Buy and set a new price target of $32.00

Wells Fargo initiated coverage of Mineralys Therapeutics with a rating of Overweight and set a new price target of $27.00

Stifel initiated coverage of Mineralys Therapeutics with a rating of Buy and set a new price target of $45.00

Credit Suisse initiated coverage of Mineralys Therapeutics with a rating of Outperform and set a new price target of $40.00

– 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 2025 – – Explore-CKD Phase 2 trial successfully achieved statistical significance in reduction of systolic BP and UACR, and demonstrated a favorable safety profile – – Explore-OSA Phase 2 trial in OSA participants with hypertension is ongoing; topline results anticipated in 1H 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as hypertensive nephropathy, obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the second quarter ended June 30, 2025, after the financial markets close on Tuesday, August 12, 2025. Tuesday, August 12th @ 4:30 p.m. ETDomestic:1-877-704-4453International:1-201-389-0920Conference ID:13754684Webcast:Webcast Link   A live webcast of the conference call may also be found on the "News & E

– Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks – – Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p<0.0001) – – Lorundrostat demonstrated a favorable safety and tolerability profile – – Conference call today at 8:00 a.m. ET – RADNOR, Pa., June 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep

– Largest hypertension trial of an aldosterone synthase inhibitor to date demonstrated the efficacy of lorundrostat in over 1,000 participants with uncontrolled or resistant hypertension in a real-world setting – – Lorundrostat 50 mg dosed once daily demonstrated clinically meaningful and sustained reductions in systolic blood pressure, with a 16.9 mmHg reduction at Week 6 (-9.1 mmHg placebo adjusted) and a 19.0 mmHg reduction at Week 12 (-11.7mm placebo adjusted) – – Lorundrostat demonstrated a favorable safety and tolerability profile – RADNOR, Pa., May 24, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on deve

RADNOR, Pa., May 20, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that data from the pivotal Phase 3 Launch-HTN trial evaluating the efficacy and safety of lorundrostat for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) will be presented in a late-breaking clinical trials session at the 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025), which will be held in Milan at the MICO

– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for

RADNOR, Pa., May 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that management will be participating in the Bank of America Securities 2025 Health Care Conference being held in Las Vegas on May 12-15, 2025. Bank of America Securities Health Care ConferenceDate: Wednesday, May 14, 2025Time: 4:35pm PDTFormat: PresentationWebcast Link    A live webcast of the presentation can be accessed under "News and Events" on the Investor Relations s

RADNOR, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the first quarter ended March 31, 2025, after the financial markets close on Monday, May 12, 2025. Monday, May 12th @ 4:30 p.m. ET Domestic:1-800-717-1738International:1-646-307-1865Conference ID:53214Webcast:Link   A live webcast of the conference call may also be found on the "News & Events" page in the Investor Relations section of

– Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile – – Lorundrostat is a highly selective aldosterone synthase inhibitor that disrupts aldosterone biosynthesis rather than blocking the mineralocorticoid receptor – – Data from Advance-HTN support the potential of lorundrostat as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension who would normally be treated in a specialist setting – RADNOR, Pa., March 29, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmace

RADNOR, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, and offer his perspective on the unmet medical need in uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), and the potential of lorundsrostat to change the current treatm

RADNOR, Pa., Jan. 04, 2024 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD) and other diseases driven by abnormally elevated aldosterone, today announced the appointment of Minji Kim, Ph.D. as Chief Business Officer. Adam Levy will remain in his role as Chief Financial Officer. "With our expanding operations, we have decided to split the functions of Chief Financial Officer and Chief Business Officer into two roles, and we are excited to have Minji join our team. She brings a solid track record of generating value for multiple companies by identify

LOS ANGELES, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Praxis Bioresearch ("Praxis"), a biopharmaceutical company focused on the discovery and development of therapeutics for chronic neuropsychiatric and neurodegenerative disorders with an initial focus on apathy in Alzheimer's Disease, today announced the appointment of Adam Levy to its Board of Directors (the "Board"). Mr. Levy brings executive, financial and operational leadership experience in biopharmaceuticals. "We are excited to have Adam join our Board and support our mission to improve the lives of patients with Alzheimer's Disease," said Sandeep Patil, MD PhD, chief executive officer of Praxis Bioresearch. "Adam brings an impressive

– 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 2025 – – Explore-CKD Phase 2 trial successfully achieved statistical significance in reduction of systolic BP and UACR, and demonstrated a favorable safety profile – – Explore-OSA Phase 2 trial in OSA participants with hypertension is ongoing; topline results anticipated in 1H 2026 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to

RADNOR, Pa., Aug. 04, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as hypertensive nephropathy, obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the second quarter ended June 30, 2025, after the financial markets close on Tuesday, August 12, 2025. Tuesday, August 12th @ 4:30 p.m. ETDomestic:1-877-704-4453International:1-201-389-0920Conference ID:13754684Webcast:Webcast Link   A live webcast of the conference call may also be found on the "News & E

– Explore-CKD met its primary endpoint; lorundrostat 25 mg once daily achieved a 9.3 mmHg reduction in systolic blood pressure, and a 7.5 mmHg placebo-adjusted reduction (p=0.0024) at four weeks – – Lorundrostat showed a clinically meaningful reduction in the pre-defined endpoint spot urine albumin-to-creatinine ratio of 31% (p<0.0001) – – Lorundrostat demonstrated a favorable safety and tolerability profile – – Conference call today at 8:00 a.m. ET – RADNOR, Pa., June 17, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep

– Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints and demonstrated a favorable safety and tolerability profile – – Anticipate Explore-CKD Phase 2 trial to deliver topline data in Q2 2025 – – Initiated Explore-OSA Phase 2 Trial in Q1 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for

RADNOR, Pa., May 05, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will report its financial results from the first quarter ended March 31, 2025, after the financial markets close on Monday, May 12, 2025. Monday, May 12th @ 4:30 p.m. ET Domestic:1-800-717-1738International:1-646-307-1865Conference ID:53214Webcast:Link   A live webcast of the conference call may also be found on the "News & Events" page in the Investor Relations section of

– Lorundrostat 50 mg dose achieved a 15.4 mmHg absolute reduction and 7.9 mmHg placebo-adjusted reduction (p=0.001), assessed by 24hr ABPM at week 12, with favorable safety and tolerability profile – – Lorundrostat is a highly selective aldosterone synthase inhibitor that disrupts aldosterone biosynthesis rather than blocking the mineralocorticoid receptor – – Data from Advance-HTN support the potential of lorundrostat as a best-in-class treatment for high-risk patients with uncontrolled or resistant hypertension who would normally be treated in a specialist setting – RADNOR, Pa., March 29, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmace

RADNOR, Pa., March 25, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will host a conference call and webinar featuring Dr. Luke Laffin of the Cleveland Clinic, who will discuss the latest results from the pivotal Advance-HTN and Launch-HTN clinical trials, and offer his perspective on the unmet medical need in uncontrolled hypertension (uHTN) or resistant hypertension (rHTN), and the potential of lorundsrostat to change the current treatm

– Launch-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a 16.9 mmHg reduction in systolic blood pressure, and a 9.1 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at week 6 –– Launch-HTN met a predefined endpoint with lorundrostat 50 mg dose achieving a 19.0 mmHg reduction in systolic blood pressure, and an 11.7 mmHg placebo-adjusted reduction (p-value < 0.0001) assessed by automated office blood pressure at end of treatment, week 12 –– Advance-HTN met its primary endpoint with lorundrostat 50 mg dose achieving a highly statistically significant 7.9 mmHg placebo-adjusted reduction assessed by 24hr ABPM at end of treatment,

RADNOR, Pa., March 07, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced it will host a conference call and webinar to announce topline results from its Launch-HTN and Advance-HTN pivotal trials on Monday, March 10, 2025, at 8:00 a.m. ET. The Launch-HTN trial evaluated the efficacy and safety of lorundrostat, a highly selective aldosterone inhibitor, for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN) as a

– Anticipate topline data from pivotal Advance-HTN trial in March 2025 and pivotal Phase 3 Launch-HTN trial in mid first half of 2025 – – Completed enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Initiating Phase 2 trial to evaluate lorundrostat for the treatment of patients with moderate-to-severe obstructive sleep apnea (OSA) and hypertension – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., Feb. 12, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and oth