Latest news with #Mineralys
Yahoo
26-05-2025
- Health
- Yahoo
Mineralys reports outcomes from trial of lorundrostat for hypertension
Mineralys Therapeutics has reported outcomes from its pivotal randomised, placebo-controlled Phase III Launch-HTN trial assessing lorundrostat for controlling hypertension. This global, double-blinded trial involved more than 1,000 subjects having uncontrolled or resistant hypertension (uHTN or rHTN), who were on two to five antihypertensive medications. Subjects were randomised and given either a placebo, lorundrostat 50mg once daily, or a dose of lorundrostat 50mg and titrated to 100mg at week six. Change from baseline in systolic blood pressure against placebo post six weeks of treatment is the primary endpoint of the trial. It was met showing a decrease in placebo-adjusted systolic blood pressure from baseline at week six. Lorundrostat dosed at 50mg once a day minimised automatised office systolic blood pressure. At week six, subjects experienced a 16.9 mmHg reduction, with a further decrease to 19 mmHg by week 12, compared to placebo. The trial's design reflected real-world clinical settings, using automated office blood pressure (AOBP) measurement and enabling subjects to maintain their current medication regimens. According to the company, lorundrostat's tolerability and safety profile was favourable, with modest on-target effects on serum electrolytes, which were quickly reversible upon discontinuation. Notably, cortisol production suppression was not observed, and there were very few serious adverse events related to the drug that required discontinuation or adjustments of dosage. Lorundrostat is an oral aldosterone synthase inhibitor targeting the treatment of hypertension, obstructive sleep apnoea, and chronic kidney disease. Mineralys Therapeutics CEO Jon Congleton said: 'The detailed results from Launch-HTN, which was designed to reflect treatment in the real-world setting, mark a pivotal milestone in our mission to deliver the first targeted aldosterone synthase inhibitor to the millions of people suffering from uncontrolled or resistant hypertension. 'With these findings in hand, we now have data from two pivotal trials in distinct-but-complementary populations that reinforce the promise of a new treatment approach for hypertension that directly addresses the dysregulated aldosterone pathway – a key driver of the condition in many patients.' In March this year, lorundrostat met the primary endpoint in two pivotal trials. "Mineralys reports outcomes from trial of lorundrostat for hypertension" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
12-03-2025
- Business
- Yahoo
Mineralys Therapeutics Announces Pricing of $175.0 Million Underwritten Public Offering of Common Stock
RADNOR, Pa., March 11, 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, announced today the pricing of an underwritten public offering of 12,962,962 shares of its common stock at a public offering price of $13.50 per share. The aggregate gross proceeds to Mineralys from the offering, before deducting underwriting discounts and commissions and other estimated offering expenses, are expected to be approximately $175.0 million. In addition, Mineralys has granted the underwriters a 30-day option to purchase up to an additional 1,944,444 shares of its common stock. All of the securities to be sold in the offering are to be sold by Mineralys. The offering is expected to close on or about March 13, 2025, subject to the satisfaction of customary closing conditions. BofA Securities, Evercore ISI, Goldman Sachs & Co. LLC, Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering. LifeSci Capital is acting as lead manager and H.C. Wainwright & Co. is acting as co-manager for the offering. Mineralys intends to use the net proceeds from the proposed offering to fund clinical development of lorundrostat, including research and development and manufacturing, and pre-commercialization activities, as well as for working capital and general corporate purposes. The securities described above are being offered by Mineralys pursuant to a shelf registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). A preliminary prospectus supplement and accompanying prospectus relating to the offering has been filed, and a final prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC. When available, copies of the final prospectus supplement and the accompanying prospectus relating to the offering may be obtained from: BofA Securities NC1-022-02-25, Attention: Prospectus Department, 201 North Tryon Street, Charlotte, North Carolina 28255-0001 or by email at Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 36th Floor, New York, New York 10055, by telephone at (888) 474-0200, or by email at Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, via telephone: (866) 471-2526, via fax: 212-902-9316, or via email: prospectus-ny@ Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, via telephone at (415) 364-2720 or via email at syndprospectus@ or Wells Fargo Securities, LLC, Attention: WFS Customer Service, 608 2nd Avenue South, Suite 1000, Minneapolis, MN 55402, by telephone at 1-800-645-3751, or by email at wfscustomerservice@ Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction. About MineralysMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. Forward-Looking StatementsStatements contained in this press release regarding matters that are not historical facts are 'forward-looking statements' within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements include statements regarding, among other things, the completion of the proposed public offering and the anticipated use of proceeds therefrom. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon Mineralys' current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include, without limitation, risks and uncertainties associated with market conditions, the satisfaction of customary closing conditions related to the proposed public offering, and the other risks described in Mineralys' filings with the SEC. All forward-looking statements contained in this press release speak only as of the date on which they were made. Mineralys undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made, except as required by law. CONTACTS Investor Relationsinvestorrelations@ Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@ in to access your portfolio
Yahoo
10-03-2025
- Business
- Yahoo
Mineralys's stock soars as hypertension pill scores in two pivotal trials
Mineralys Therapeutics's oral hypertension therapy, lorundrostat, has met the primary endpoint in two pivotal studies, boosting the company's stock price. The Phase III Launch-HTN (NCT06153693) and Phase II Advance-HTN (NCT05769608) trials evaluated the efficacy and safety of lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The biopharma's stock, listed on the Nasdaq exchange, rose by 65.59% on the news from a 7 March market close of $10.52 to a 10 March market high of $17.42 (correct as of 11:45am EST). The Launch-HTN trial met its primary endpoint, demonstrating a 16.9mmHg reduction in systolic blood pressure, and a 9.1mmHg placebo-adjusted reduction, after six weeks. This rose to a 19.0mmHg reduction in systolic blood pressure, and an 11.7mmHg placebo-adjusted reduction, after 12 weeks. The randomised, double-blinded, placebo-controlled trial enrolled patients who failed to achieve their blood pressure goal despite being on two to five antihypertensive medications. The Advance-HTN trial met its primary endpoint with a 7.9mmHg placebo-adjusted reduction in systolic blood pressure, assessed with 24-hour average blood pressure measurement after 12 weeks in patients treated with 50mg of lorundrostat. The randomised, double-blind, placebo-controlled study evaluated the drug as an add-on therapy to background treatment of two or three antihypertensive medications. The therapy remained safe and well tolerated in both studies, with Mineralys reporting that 14 patients in the Launch-HTN trial suffered serious adverse events (SAEs). There was also some incidence of hyperkalemia (serum potassium above 6.0mmol/L). Mineralys Therapeutics CEO Jon Congleton said: 'We have now completed three successful clinical trials demonstrating the efficacy, safety and tolerability of lorundrostat and the importance of targeting dysregulated aldosterone. We believe the clinical profile observed for lorundrostat supports the potential regulatory approval of this novel agent and its significant commercial value.' Further data from the studies will be presented at upcoming medical conferences and in peer-reviewed publications. The US-headquartered company previously announced positive data from the Phase II Target-HTN study. Mineralys is also running the Transform-HTN open-label extension trial to allow patients to continue receiving lorundrostat while generating additional safety and efficacy data. According to GlobalData forecasts, sales of lorundrostat could reach $601m in 2030. GlobalData is the parent company of Clinical Trials Arena. In November 2024, MSD's Winrevair (sotatercept-csrk) met the primary endpoint in a Phase III trial in patients with pulmonary arterial hypertension (PAH). "Mineralys's stock soars as hypertension pill scores in two pivotal trials" was originally created and published by Clinical Trials Arena, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site.
Yahoo
07-03-2025
- Business
- Yahoo
Mineralys Therapeutics to Announce Topline Data from Launch-HTN and Advance-HTN Pivotal Trials Monday, March 10, 2025, at 8:00 AM ET
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 an add-on therapy to an existing, prescribed background treatment of two to five antihypertensive medications. The Advance-HTN trial evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN when used as an add-on therapy to a standardized background treatment of two or three anti-hypertensive 1-877-704-4453 International: 1-201-389-0920 Webcast: 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 website. About Mineralys TherapeuticsMineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit Follow Mineralys on LinkedIn and Twitter. Contact: Investor Relationsinvestorrelations@ Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@ in to access your portfolio
