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Mineralys Therapeutics, Inc. - MLYS STOCK NEWS

Welcome to our dedicated page for Mineralys Therapeutics news (Ticker: MLYS), a resource for investors and traders seeking the latest updates and insights on Mineralys Therapeutics stock.

Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is a clinical-stage biopharmaceutical company based in Radnor, Pennsylvania, dedicated to developing innovative medicines for managing hypertension, chronic kidney disease (CKD), and other conditions driven by abnormally elevated aldosterone levels. The company's flagship product, lorundrostat, is an orally administered, highly selective aldosterone synthase inhibitor. This medication is designed to treat patients with uncontrolled hypertension—defined as those unable to achieve blood pressure below 130/80 mmHg even with two or more antihypertensive medications—and resistant hypertension, affecting those who cannot reach the target BP despite taking three or more medications, including a diuretic.

Mineralys Therapeutics aims to revolutionize hypertension management by moving away from the traditional trial-and-error approach and introducing a more personalized treatment strategy. The company’s recent accomplishments underscore this commitment: the publication of their proof-of-concept study, Target-HTN, in the Journal of the American Medical Association, and the initiation of the Phase 3 Launch-HTN and Phase 2 Explore-CKD trials.

The company recently revealed robust financial results for the third quarter of 2023, reporting cash, cash equivalents, and investments totaling $265.9 million as of September 30, 2023, ensuring sufficient funding for planned clinical studies and operations through mid-2025. Mineralys also saw significant increases in both R&D and G&A expenses, attributed to the ramp-up in clinical activities and the transition to operating as a public company.

Mineralys’ lorundrostat has shown promising results in early trials, demonstrating a substantial reduction in plasma aldosterone concentration and clinically meaningful reductions in blood pressure among participants. The company is actively enrolling subjects in pivotal trials and expects to commence the Launch-HTN trial by the end of 2023, targeting real-world applications and responder profiling through biomarker-driven approaches.

Moreover, Mineralys is also focused on chronic kidney disease, which affects over 10% of the global population. Lorundrostat’s potential to treat CKD by targeting aldosterone—an underlying driver in cardiorenal conditions—positions Mineralys at the forefront of tackling complex, interrelated health issues.

For more information, visit their official website at https://mineralystx.com and follow Mineralys on LinkedIn and Twitter.

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Mineralys Therapeutics, Inc. (NASDAQ: MLYS) will announce its first quarter 2024 financial results on May 9, 2024. The company focuses on developing medicines for hypertension, chronic kidney disease, and other diseases related to dysregulated aldosterone. The conference call will be hosted at 8:30 a.m. ET, offering dial-in and webcast options for participants.

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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) is progressing well with its pivotal trials for lorundrostat, focusing on treating hypertension and chronic kidney disease. Financially, the company reported a strong balance sheet with $239.0 million in cash, cash equivalents, and investments as of December 31, 2023. However, the company experienced significant increases in research and development expenses, leading to a net loss of $71.9 million for the year ended December 31, 2023.
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Mineralys Therapeutics, Inc. (MLYS) to report financial results for Q4 and full year 2023 on March 21, 2024. The company focuses on developing medicines for hypertension and chronic kidney disease.
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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) has announced a private placement financing (PIPE) with institutional accredited investors, raising approximately $120 million in gross proceeds. The financing involves selling 8.9 million shares of common stock at a price of $13.50 per share. The company plans to use the net proceeds to fund the research and development of lorundrostat, in addition to working capital and general corporate purposes.
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Mineralys Therapeutics, Inc. CEO Jon Congleton will participate in a fireside chat at the Guggenheim Securities 6th Annual Biotechnology Conference in New York City on February 8, 2024. The company focuses on developing medicines for hypertension, chronic kidney disease, and other diseases driven by elevated aldosterone levels.
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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announced the appointment of Minji Kim, Ph.D. as Chief Business Officer, splitting the functions of CFO and CBO into two roles. Dr. Kim brings over two decades of experience in business development, strategic leadership, and scientific research, having worked with biotech companies in the U.S. and overseas. She has a solid track record of generating value for companies and brings extensive experience in the pharmaceutical industry.
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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announces the dosing of the first subject in the Launch-HTN pivotal trial to evaluate the safety and efficacy of lorundrostat for the treatment of uncontrolled or resistant hypertension. The company expects to release topline data from the confirmatory Launch-HTN trial in the second half of 2025 and from the ongoing Advance-HTN pivotal trial in the second half of 2024.
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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) presents new data from the Target-HTN Phase 2 trial at the American Heart Association Scientific Sessions 2023. The analysis reveals a positive feedback loop between obesity, leptin, and aldosterone, indicating potential benefits for obese patients with uncontrolled or resistant hypertension from lorundrostat treatment. Serum leptin levels and BMI are correlated, suggesting leptin as a biomarker for lorundrostat-responsive individuals.
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Mineralys Therapeutics, Inc. (NASDAQ: MLYS) announced senior management's participation in upcoming healthcare conferences in New York, London, and Miami. The company will present and engage in fireside chats, discussing its focus on developing medicines for hypertension, chronic kidney disease, and other aldosterone-driven diseases.
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Mineralys Therapeutics, Inc. (Nasdaq: MLYS) announces plans to initiate Phase 3 pivotal Launch-HTN trial of lorundrostat to treat uncontrolled or resistant hypertension in 2H 2023, with a Phase 2 Explore-CKD trial also set to start in the same period. The company reported financial results for Q3 2023 and provided corporate updates, including the addition of two new Board members and the upcoming poster presentation at AHA Scientific Sessions 2023.
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FAQ

What is the current stock price of Mineralys Therapeutics (MLYS)?

The current stock price of Mineralys Therapeutics (MLYS) is $13.465 as of November 1, 2024.

What is the market cap of Mineralys Therapeutics (MLYS)?

The market cap of Mineralys Therapeutics (MLYS) is approximately 666.3M.

What does Mineralys Therapeutics specialize in?

Mineralys Therapeutics specializes in developing medicines for hypertension, chronic kidney disease (CKD), and other conditions driven by elevated aldosterone levels.

What is lorundrostat?

Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor developed by Mineralys Therapeutics for treating uncontrolled and resistant hypertension and CKD.

What recent milestones has Mineralys achieved?

Recently, Mineralys published their Target-HTN study in JAMA, initiated Phase 3 Launch-HTN and Phase 2 Explore-CKD trials, and announced strong financial results for Q3 2023.

How is Mineralys changing hypertension management?

Mineralys aims to replace the trial-and-error approach with a personalized treatment strategy using lorundrostat, targeting aldosterone-driven hypertension more effectively.

What are the financial highlights for Mineralys in Q3 2023?

Mineralys reported cash, cash equivalents, and investments of $265.9 million as of September 30, 2023, supporting clinical studies and operations through mid-2025.

Where is Mineralys Therapeutics headquartered?

Mineralys Therapeutics is headquartered in Radnor, Pennsylvania.

How can I follow Mineralys for updates?

You can follow Mineralys on their official website, LinkedIn, and Twitter for the latest updates and news.

What is the significance of aldosterone in hypertension and CKD?

Aldosterone plays a crucial role in driving hypertension and CKD. Mineralys targets this hormone with lorundrostat to address these conditions more effectively.

What is the Target-HTN trial?

The Target-HTN trial is a Phase 2 proof-of-concept study evaluating lorundrostat's safety and efficacy in treating uncontrolled or resistant hypertension.

What is Mineralys' latest product development news?

Mineralys announced the dosing of the first subject in the Launch-HTN pivotal trial for evaluating lorundrostat's safety and efficacy in treating uncontrolled hypertension.

Mineralys Therapeutics, Inc.

Nasdaq:MLYS

MLYS Rankings

MLYS Stock Data

666.34M
49.73M
2.55%
100.62%
3.24%
Biotechnology
Pharmaceutical Preparations
Link
United States of America
RADNOR