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MLYS Overview

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$
0.000
0.000(0.000%)
At close
0.000(0.000%)Aft-market
ET
$
0.000
0.000(0.000%)
At close
0.000(0.000%)Aft-market
ET
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Intellectia

Loading chart...

High
28.670
Open
28.310
VWAP
27.75
Vol
1.26M
Mkt Cap
2.21B
Low
26.620
Amount
34.99M
EV/EBITDA(TTM)
--
Total Shares
79.14M
EV
1.66B
EV/OCF(TTM)
--
P/S(TTM)
--
Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Lorundrostat is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. It has completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). It is also investigating the benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.
Show More

Events Timeline

(ET)
2026-03-09
16:40:00
Mineralys Therapeutics' Lorundrostat NDA Accepted by FDA
select
2026-01-06 (ET)
2026-01-06
08:10:00
Mineralys Therapeutics Issues Corporate Update on Clinical Progress
select
2025-11-14 (ET)
2025-11-14
12:01:56
Mineralys Therapeutics Experiences a 11.3% Decline
select

News

seekingalpha
9.0
03-10seekingalpha
FDA Accepts Marketing Application for Mineralys' Lorundrostat
  • FDA Application Accepted: Mineralys Therapeutics' marketing application for lorundrostat has been accepted by the FDA, marking a significant advancement in the treatment of hypertension, which is expected to enhance market recognition and investor confidence.
  • Clinical Trial Results: In the Phase 2 Explore-OSA trial, although no clinically meaningful difference was observed in the primary endpoint, the significant reduction in blood pressure and favorable safety profile were deemed clinically meaningful, indicating the drug's potential in difficult-to-control hypertension patients.
  • Market Outlook: The FDA has set a target action date of December 22, 2026, and if approved, this could open new revenue streams for the company and potentially secure a position in the competitive hypertension drug market.
  • CEO Commentary: CEO Jon Congleton noted that despite the primary endpoint not being met, the drug's blood pressure-lowering effects and safety profile remain clinically significant, reflecting the company's ongoing commitment to developing new therapies.
NASDAQ.COM
9.0
03-10NASDAQ.COM
Mineralys Therapeutics' NDA for Lorundrostat Accepted by FDA
  • FDA Acceptance: Mineralys Therapeutics announced that the FDA has accepted its New Drug Application for Lorundrostat, with a decision expected on December 22, 2026, marking a significant step in the company's potential market entry for hypertension treatment.
  • Clinical Trial Success: The NDA submission is supported by three positive clinical trials demonstrating Lorundrostat's safety and ability to control blood pressure over 24 hours, indicating its potential as a new treatment option for uncontrolled hypertension.
  • Explore-OSA Trial Findings: Although the Explore-OSA trial did not show a significant reduction in the apnea-hypopnea index (AHI), Lorundrostat demonstrated clinically meaningful blood pressure reductions and a favorable safety profile, enhancing its prospects for use in difficult-to-treat hypertension patients.
  • Upcoming Financial Results: The company is set to report its financial results for Q4 and the full year 2025 on March 12, 2026, with investors keenly awaiting insights into the financial implications of its drug development progress.
Newsfilter
9.0
03-09Newsfilter
FDA Accepts Mineralys' NDA for Lorundrostat Targeting Hypertension
  • FDA Approval Milestone: The FDA has accepted Mineralys Therapeutics' NDA for lorundrostat, with a target action date of December 22, 2026, marking a significant milestone in addressing the needs of patients with resistant hypertension.
  • Clinical Trial Insights: The Explore-OSA trial demonstrated a clinically meaningful blood pressure reduction of 11.1 mmHg with lorundrostat, alongside a favorable safety profile, indicating its potential as a new treatment option for difficult-to-control hypertension.
  • Significant Market Demand: Hypertension contributes to an economic burden of approximately $219 billion in the U.S., with around 30% of hypertensive patients experiencing difficulties due to dysregulated aldosterone, suggesting a substantial market opportunity for lorundrostat.
  • Future Development Prospects: Mineralys plans to further validate lorundrostat's efficacy in upcoming clinical trials, potentially providing new treatment options for hypertension patients and driving growth in the biopharmaceutical sector.
Newsfilter
2.0
03-03Newsfilter
Chronic Kidney Disease Market Growth Drivers
  • Market Size Growth: According to analysis, the chronic kidney disease (CKD) market size was approximately $4.8 billion in 2024 and is expected to grow further by 2034, reflecting increased demand for new therapies and an expanding patient base.
  • Rising Patient Numbers: In 2024, there were about 82 million prevalent cases of CKD across the 7 major markets (7MM), with projections indicating continued growth from 2025 to 2034, primarily driven by an aging population and the rising prevalence of diabetes and hypertension.
  • Launch of New Therapies: The introduction of emerging therapies such as AstraZeneca's Zibotentan/Dapagliflozin and Boehringer Ingelheim's Vicadrostat + Empagliflozin is expected to significantly boost market growth and improve treatment outcomes for patients.
  • Advancements in Biomarkers: Progress in biomarkers like KIM-1 and NGAL enables more precise early detection of CKD, thereby enhancing the potential for timely interventions and improving overall patient prognosis.
NASDAQ.COM
2.0
02-13NASDAQ.COM
MLYS Stock 52-Week Highs and Lows Analysis
  • Price Fluctuation Analysis: MLYS's 52-week low is $8.241 per share, while the high is $47.65, with the last trade at $28.26, indicating significant volatility in the stock price over the past year, reflecting varying market perceptions.
  • Technical Indicator Focus: The current price of $28.26 is below the 200-day moving average, which may signal increased selling pressure in the short term, prompting investors to monitor subsequent market reactions to assess potential risks.
  • Market Sentiment Assessment: Although the current price is significantly above the 52-week low, it remains below the high, suggesting a cautious market sentiment, necessitating investors to consider the overall market environment and the company's fundamentals in their decision-making.
  • Investor Strategy Adjustment: Given the price fluctuations and changes in technical indicators, investors may need to reassess their holding strategies to manage potential market volatility and risk management needs.
Newsfilter
5.0
02-12Newsfilter
Mineralys Grants Stock Options to New Employees
  • Stock Option Grants: On February 9, 2026, Mineralys Therapeutics awarded 33,504 stock options and 25,128 restricted stock units to two new non-executive employees, aimed at attracting talent and enhancing employee loyalty.
  • Incentive Plan Details: The stock options will vest over four years, with 25% vesting in the first year and the remainder vesting at a rate of 1/48 each month, ensuring continued employee contributions during their tenure.
  • Compliance Assurance: The grants comply with Nasdaq Listing Rule 5635(c)(4), demonstrating the company's commitment to transparency and compliance in attracting new employees, which enhances investor confidence.
  • Company Background: Mineralys focuses on developing medicines for hypertension and related comorbidities, with its lead candidate, lorundrostat, being an orally administered selective aldosterone synthase inhibitor, showcasing the company's innovative potential in the biopharmaceutical sector.
Wall Street analysts forecast MLYS stock price to rise
6 Analyst Rating
Wall Street analysts forecast MLYS stock price to rise
6 Buy
0 Hold
0 Sell
Strong Buy
Current: 0.000
sliders
Low
46.00
Averages
52.60
High
56.00
Current: 0.000
sliders
Low
46.00
Averages
52.60
High
56.00
Stifel
Buy
maintain
$45 -> $52
AI Analysis
2025-12-19
Reason
Stifel
Price Target
$45 -> $52
AI Analysis
2025-12-19
maintain
Buy
Reason
Stifel raised the firm's price target on Mineralys Therapeutics to $52 from $45 and keeps a Buy rating on the shares as part of a 2026 outlook note for the analyst's Biopharma coverage.
BofA
Buy
maintain
$43 -> $46
2025-12-19
Reason
BofA
Price Target
$43 -> $46
2025-12-19
maintain
Buy
Reason
BofA raised the firm's price target on Mineralys Therapeutics to $46 from $43 and keeps a Buy rating on the shares after the company reported Q3 results and guided for a cash runway into 2027. A "major potential catalyst" would be Mineralys finding a commercialization and development partner, which the firm views as "necessary to maximize value," the analyst tells investors.
Unlock Full Analyst Thesis, Get the complete breakdown of rating reason for MLYS
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Valuation Metrics

The current forward P/E ratio for Mineralys Therapeutics Inc (MLYS.O) is -16.21, compared to its 5-year average forward P/E of -5.82. For a more detailed relative valuation and DCF analysis to assess Mineralys Therapeutics Inc's fair value, Click here.

Forward PE

The forward P/E ratio is a valuation metric that divides a company's current stock price by its estimated future earnings per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PE
-5.82
Current PE
-16.21
Overvalued PE
-1.04
Undervalued PE
-10.60

Forward EV/EBITDA

The forward EV/EBITDA ratio is a valuation metric that divides a company's enterprise value (EV) by its estimated future earnings before interest, taxes, depreciation, and amortization (EBITDA) over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average EV/EBITDA
-3.86
Current EV/EBITDA
-10.89
Overvalued EV/EBITDA
0.24
Undervalued EV/EBITDA
-7.97

Forward PS

The forward P/S ratio is a valuation metric that divides a company's current stock price by its estimated future sales (or revenue) per share over the next 12 months.
StronglyUndervaluedUndervaluedFairOvervaluedStronglyOvervalueddotted line Image
N/A
5Y Average PS
0.00
Current PS
0.00
Overvalued PS
0.00
Undervalued PS
0.00

Financials

AI Analysis
Annual
Quarterly

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Whales Holding MLYS

B
Boothbay Fund Management, LLC
Holding
MLYS
+11.67%
3M Return
A
Artal Group S.A.
Holding
MLYS
+7.65%
3M Return
N
Nationale-Nederlanden Powszechne Towarzystwo Emerytalne S.A.
Holding
MLYS
+6.66%
3M Return
S
Suvretta Capital Management, LLC
Holding
MLYS
+1.43%
3M Return
R
RA Capital Management, L.P.
Holding
MLYS
+1.17%
3M Return
O
OrbiMed Advisors LLC
Holding
MLYS
-0.39%
3M Return

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Frequently Asked Questions

What is Mineralys Therapeutics Inc (MLYS) stock price today?

The current price of MLYS is 27.97 USD — it has decreased -1.62

What is Mineralys Therapeutics Inc (MLYS)'s business?

Mineralys Therapeutics, Inc. is a clinical-stage biopharmaceutical company. The Company is focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone. Its product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor (ASI) that the Company is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Lorundrostat is designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for producing the hormone. It has completed the Target-HTN trial, a Phase II proof-of-concept trial for lorundrostat in the treatment of uncontrolled hypertension (uHTN) and resistant hypertension (rHTN). It is also investigating the benefits of lorundrostat in subjects with hypertension and CKD and in subjects with hypertension and OSA.

What is the price predicton of MLYS Stock?

Wall Street analysts forecast MLYS stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for MLYS is52.60 USD with a low forecast of 46.00 USD and a high forecast of 56.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.

What is Mineralys Therapeutics Inc (MLYS)'s revenue for the last quarter?

Mineralys Therapeutics Inc revenue for the last quarter amounts to -41.13M USD, decreased -31.57

What is Mineralys Therapeutics Inc (MLYS)'s earnings per share (EPS) for the last quarter?

Mineralys Therapeutics Inc. EPS for the last quarter amounts to -28872000.00 USD, decreased -42.51

How many employees does Mineralys Therapeutics Inc (MLYS). have?

Mineralys Therapeutics Inc (MLYS) has 51 emplpoyees as of March 12 2026.

What is Mineralys Therapeutics Inc (MLYS) market cap?

Today MLYS has the market capitalization of 2.21B USD.