MLYS - Earnings announcements

–  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., March 12, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the fourth quarter and full year ended December 31, 2025, and provided a corporate update. "Mineralys had a transformational year in 2025, defined by significan

RADNOR, Pa., March 09, 2026 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as 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 fourth quarter and full year ended December 31, 2025, after the financial markets close on Thursday, March 12, 2026. Thursday, March 12th @ 4:30 p.m. ETDomestic:1-877-704-4453International:1-201-389-0920Conference ID:13758574Webcast:Link A live webcast of the conference call may also be found on the "News & Eve

– 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 today at 4:30 p.m. ET – RADNOR, Pa., Nov. 10, 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 chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the third quarter ended September 30, 2025, and provided a corporate update. "We are at an excitin

RADNOR, Pa., Nov. 03, 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 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 third quarter ended September 30, 2025, after the financial markets close on Monday, November 10, 2025. Monday, November 10th @ 4:30 p.m. ETDomestic:1-877-704-4453International:1-201-389-0920Conference ID:13756051Webcast:Webcast Link A live webcast of the conference call may also be found on the "

– 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

RADNOR, Pa., Feb. 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 fourth quarter and full year ended December 31, 2024, before the financial markets open on Wednesday, February 12, 2025. Wednesday, February 12th @ 8:30 a.m. ET Domestic:1-800-717-1738International:1-646-307-1865Webcast:Link A live webcast of the conference call may also be found on the "News & Events" page in the Investor Relati

– Completed enrollment in pivotal Advance-HTN trial and anticipate topline data in March 2025 – – Completed enrollment ahead of schedule in pivotal Phase 3 Launch-HTN trial and anticipate delivering topline data in mid first half of 2025 – – Ongoing enrollment in Explore-CKD Phase 2 trial and anticipate delivering topline data in Q2 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 11, 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 dysregulated aldosterone, today announced financial results fo

RADNOR, Pa., Nov. 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 dysregulated aldosterone, today announced it will report its financial results from the third quarter ended September 30, 2024, after the financial markets close on Monday, November 11, 2024. Monday, November 11th @ 4:30 p.m. ET Domestic:1-877-407-9127International:1-201-689-8574Webcast:Link   A live webcast of the conference call may also be found on the "News & Events" page in the Investor Relations section of the Mineralys Therapeutics websi

– Advance-HTN trial is approximately 90% enrolled; trial is anticipated to deliver topline data in Q1 2025 – – Enrollment ahead of schedule in Phase 3 pivotal Launch-HTN trial and on track to deliver topline data as anticipated in 2H 2025 – – Ongoing Explore-CKD Phase 2 trial is ramping up enrollment under the amended protocol and is anticipated to deliver topline data in 1H 2025 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 13, 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 dysregulated aldost

RADNOR, Pa., Aug. 05, 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 dysregulated aldosterone, today announced it will report its financial results from the second quarter ended June 30, 2024, after the financial markets close on Tuesday, August 13, 2024. Tuesday, August 13th @ 4:30 p.m. ETDomestic:1-877-407-9127International:1-201-689-8574Webcast:Link   A live webcast of the conference call may be found here or on the "News & Events" page in the Investor Relations section of the Mineralys Therapeutics websi

– Advance-HTN trial of lorundrostat for the treatment of uHTN or rHTN is anticipated to deliver topline data in Q4 2024 – – Ongoing Phase 3 pivotal Launch-HTN trial of lorundrostat for the treatment of uHTN or rHTN is anticipated to deliver topline data in 2H 2025 – – Ongoing Explore-CKD Phase 2 trial is anticipated to deliver topline data in Q4 2024 to Q1 2025 – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., May 09, 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 dysregulated aldosterone, today announ

RADNOR, Pa., May 02, 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 dysregulated aldosterone, today announced it will report its financial results from the first quarter ended March 31, 2024, before the financial markets open on Thursday, May 9, 2024. Thursday, May 9th @ 8:30 a.m. ETDomestic:1-888-886-7786International:1-416-764-8658Conference ID:93715931Webcast:Link   Participants can use the dial-in information above or choose the Call me™ option (click here) for instant telephone access to the event which will

 – Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with topline data expected for Advance-HTN trial in Q4 2024 and Launch-HTN trial in 2H 2025 – – Explore-CKD Phase 2 trial, a study for lorundrostat in hypertensive patients with stage 2-3b CKD on track for Q4 2024 to Q1 2025 topline data – – Conference call today at 8:30 a.m. ET – RADNOR, Pa., March 21, 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 financial re

RADNOR, Pa., March 13, 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 it will report its financial results from the fourth quarter and full year ended December 31, 2023, before the financial markets open on Thursday, March 21, 2024. Thursday, March 21st @ 8:30 a.m. ET Domestic:1-888-886-7786International:1-416-764-8658Conference ID:27947513Webcast:Link   Participants can use the dial-in information above or choose the Call me™ option (click here) for instant telepho

– On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or resistant hypertension in 2H 2023 – – Expect to initiate planned Phase 2 Explore-CKD trial of lorundrostat alone and in combination with SGLT2 inhibitor to treat hypertensive patients with chronic kidney disease (CKD) in 2H 2023 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Nov. 07, 2023 (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 finan

RADNOR, Pa., Oct. 31, 2023 (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 it will report its financial results from the third quarter ended September 30, 2023, after the financial markets close on Tuesday, November 7, 2023. Tuesday, November 7th @ 4:30 p.m. ET Domestic: 1-888-886-7786  International:1-416-764-8658  Conference ID:27015887  Webcast:Link   If you would like a call back, please click this link, which will be made active 15 minutes prior to the scheduled sta

– Continue enrolling subjects in ongoing pivotal Advance-HTN trial of lorundrostat, for the treatment of patients with uncontrolled or resistant hypertension – – On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat for the treatment of uncontrolled or resistant hypertension in 2H 2023 – – Announced expansion of planned Phase 2 trial of lorundrostat alone and in combination with SGLT2 inhibitor to treat patients with chronic kidney disease (CKD), expect to initiate enrollment in 2H 2023 – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., Aug. 07, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company

RADNOR, Pa., July 31, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the second quarter ended June 30, 2023, after the financial markets close on Monday, August 7, 2023. Monday, August 7th @ 4:30 p.m. ET Domestic:   1-877-704-4453International: 1-201-389-0920Conference ID:13739672Webcast:   Link    If you would like a call back, please click this link, which will be made active 15 minutes prior to the scheduled start time. A live webcast of the conference call may be found her

– Commenced patient dosing in lorundrostat pivotal clinical program, for the treatment of patients with uncontrolled or resistant hypertension in April 2023 – – Plan to initiate the second pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled or resistant hypertension in the second half of 2023 – – Plan to initiate a Phase 2 trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled or resistant hypertension in a chronic kidney disease (CKD) population – – Conference call today at 4:30 p.m. ET – RADNOR, Pa., May 15, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopha

RADNOR, Pa., May 01, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the first quarter ended March 31, 2023, after the financial markets close on Monday, May 15, 2023. The Company's management team will host a conference call at 4:30 p.m. ET on Monday, May 15, 2023. To access the call, please dial 1-877-704-4453 in the U.S. or 1-201-389-0920 if you are outside the U.S., followed by the conference ID: 13737778. If you would like a call back, please click this link, which will b

RADNOR, Pa., March 01, 2023 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (NASDAQ:MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target diseases driven by abnormally elevated aldosterone, today announced it will report its financial results from the fourth quarter ended December 31, 2022, after the financial markets close on Wednesday, March 15, 2023. The Company's management team will host a conference call at 4:30 p.m. ET on Wednesday, March 15, 2023. To access the call, please dial 1-877-704-4453 in the U.S. or 1-201-389-0920 outside the U.S., followed by the conference ID: 13736564. A live webcast of the conference call may be found here. A rep