| Catalyst | Drug/Treatment | Stage | Probability of Approval | Description | Drug Type | Therapeutic Area | Source |
|---|---|---|---|---|---|---|---|
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Cardiovascular System | ||
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Cardiovascular System | ||
PDUFA Date example | PDUFA | — | Subscribe to access the data. | Small Molecules | Cardiovascular System |
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Mineralys Therapeutics, Inc.$27.21
+0.5 (+1.87%)
D 33Pipeline Score Richly Valued Biotech · Clinical
Market Cap
2.46 B
EPS
-2.06
P/E Ratio
-
Value Trade
203.94 M
SEC Financials
Q1 2026Dilution Risk
R&D Expenses
24.36 M
Operating CF
-39.47 M
Total Assets
652.86 M
Total Liabilities
652.86 M
Equity
638.14 M
D/E Ratio
12,345
9.38 %
Week
2.61 %
1 Month
7.22 %
3 Month
-27.86 %
6 Month
41.47 %
5 Year
41.47 %
All Time
Cash Data
Cash Position
112.78 M
Monthly Burn
13.16 M
Runway
5.9 mo
Burn Trend
StableSEC Filing
May 6, 2026
Overview
Volume
830.70 K
52 Week Range
12.59 - 47.65
% held by Insiders
26.35 %
% held by Institutions
82.26 %
Enterprise Value
1.82 B
Total Shares
82.47 M
Short %
16.59 %
Float Shares
57.57 M
Company Description
locked
Upcoming Catalyst
Catalyst Timeline
Dated clinical, regulatory & corporate events for Mineralys Therapeutics, Inc.
164Total events
1Upcoming
41Tier-1 (high impact)
2022 – 2026Coverage
Upcoming catalysts 1
TBD
T1PDUFA Date
Subscribe to view catalyst details
Event history 2
TBD
◆Poster PresentationlorundrostatFiledPresentation
Subscribe to view catalyst details
TBD
◆Oral PresentationPresentation
Subscribe to view catalyst details
Past FDA Catalysts & PDUFA Decisions
| Date | Drug | Catalyst | Stage | Outcome | Reaction | Event Move % | Best Trade % |
|---|---|---|---|---|---|---|---|
2025-12-31 | Lorundrostat (aldosterone synthase inhibitor) | NDA Filing | NDA | — | – | – | – |
2025-12-31 | Lorundrostat (aldosterone synthase inhibitor) | NDA Filing | NDA | — | – | – | – |
2025-12-31 | Lorundrostat (aldosterone synthase inhibitor) | NDA Filing | NDA | — | – | – | – |
Drug Pipeline Intelligence
D33
Pipeline Score $347M
Pipeline ValueRichly Valued
Valuation Signal2
Drugs Scored0.1x
rNPV / MCap Top 45%
Small Cap (rank 503 of 913)
Percentile RankMineralys Therapeutics, Inc. faces pipeline headwinds (33/100), with $722M risk-adjusted pipeline value, led by lorundrostat in Hypertension (Phase 3).
Showing 1 of 1 assets
| Drug | Indication | Phase | NCT ID | PTRS | rNPV | Status | Enrollment | Velocity | Design | Completion | ML Signal | Last Change |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| lorundrostat Small molecule | Hypertension | Phase 3 | NCT05968430 | 43% | $389M | ACTIVE NOT_RECRUITING | 2,444 | AVERAGE | C (43) | May 1, 2027 | LOW_RISK | LOW Jul 24, 2026 |
Clinical Trial Results
| Drug Name | Indications | Phase | Date | Trial Results Summary | Title | Source |
|---|---|---|---|---|---|---|
lorundrostat | uncontrolled hypertension | Phase 3 | 2026-06-08 | 40-70% reduction in plasma aldosterone concentration | Mineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026) Read More | |
lorundrostat | uncontrolled hypertension | Phase 3 | 2026-06-08 | 40-70% reduction in plasma aldosterone concentration | Mineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026) Read More | |
lorundrostat | uncontrolled hypertension | Phase 3 | 2026-06-08 | 40-70% reduction in plasma aldosterone concentration | Mineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026) Read More |
Inside Trades
YEARLY INSIDER TRANSACTIONS
Sector Avg.
INSIDERS
SOLDINSIDERS
BOUGHT
SOLDINSIDERS
BOUGHT
POSITIVE SENTIMENT Based on 22 Insiders Transactions
Hedge Funds
Shares Held
HEDGE FUNDS
SOLDHEDGE FUNDS
BOUGHT
SOLDHEDGE FUNDS
BOUGHT
POSITIVE SENTIMENT Based on 27 hedge funds in the last quarter
18 buying (3 new)·9 selling (1 exited)·2 unchanged
Hedge Funds invested in MLYS
| HedgeFund Name ( 3 ) | % of Portfolio | Current MV - | Shares Owned - | Activity Avg Price $0 |
|---|---|---|---|---|
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K | |
Example Capital Management | 2.5 % | 15.00 M | 250.00 K |
MLYS Institutional Ownership Trends
Current Insider %
5.20%
—+0.00%
Current Institutional %
62.40%
—+0.00%
Total Ownership
67.60%
Insider + Institutional
Data Points
1
1 Ticker(s)
Option Chain Statistics
| Expiration | Volume | Open Interest | Implied Volatility Calls | Implied Volatility Puts | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Calls | Puts | Put-Call Ratio | Calls | Puts | Put-Call Ratio | IV | OiWaIv | VWaIv | IV | OiWaIv | VWaIv | |
| 2026-12-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-12-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
| 2026-12-18 | 0 | 0.00 | 0 | 0 | - | - | - | - | - | - | ||
Option Chain
| Calls | Strike | Puts | ||||
|---|---|---|---|---|---|---|
| Last Price | Volume | Open Interest | Last Price | Volume | Open Interest | |
| No data available | ||||||
Open interest
Today's Open Interest
1.00 M
Put-Call Ratio
1.1
Put Open Interest
480.00 K
Call Open Interest
520.00 K
Open Interest Avg (30-day)
900,000
Today vs Open Interest Avg (30-day)
11.11%
Option Volume
Today's Volume
750.00 K
Put-Call Ratio
0.95
Put Volume
360.00 K
Call Volume
390.00 K
Volume Avg (30-day)
800,000
Today vs Volume Avg (30-day)
-6.25%
Company News
MLYSMineralys Therapeutics Presents Late-Breaking Data on Lorundrostat and Heart Failure Risk Biomarkers at The Endocrine Society Annual Meeting (ENDO 2026)
Mineralys Therapeutics presented late-breaking data at ENDO 2026, showing that lorundrostat significantly reduces heart failure risk biomarkers in patients with uncontrolled hypertension. The analysis from the Launch-HTN and Advance-HTN trials indicates that lorundrostat may positively influence pathways involved in heart failure. The drug is currently under FDA review, with a target decision date set for December 22, 2026.
Read more →MLYS▼ -5%on this news
Mineralys Therapeutics to Participate in the Goldman Sachs 47th Annual Global Healthcare Conference
Mineralys Therapeutics, a biopharmaceutical company, will participate in the Goldman Sachs 47th Annual Global Healthcare Conference from June 8-10, 2026. The event will take place in Miami, and a live webcast of the fireside chat will be available on their website. Mineralys focuses on developing treatments for hypertension and related comorbidities.
Read more →MLYS▼ -5%on this news
Mineralys Therapeutics to Present Late-Breaking Data on Lorundrostat at The Endocrine Society Annual Meeting (ENDO 2026)
Mineralys Therapeutics announced that late-breaking data from their clinical trials of lorundrostat will be presented at the Endocrine Society's annual meeting, ENDO 2026. The poster presentation will showcase findings regarding the drug's ability to modulate heart failure risk biomarkers in participants with uncontrolled hypertension. This investigational therapy targets dysregulated aldosterone levels, a major contributor to hypertension. The presentation reflects confidence in lorundrostat's efficacy and safety based on completed late-stage clinical trials.
Read more →MLYS▼ -13.1%on this newsshared move
Mineralys Therapeutics Announces Repurchase of Royalty Obligations in Tanabe License Agreement and Concurrent Financing
Mineralys Therapeutics has announced the repurchase of its royalty obligations related to lorundrostat from Tanabe Pharma for $200 million upfront and up to $100 million based on future milestones. Concurrently, the company secured a $500 million senior secured term loan and priced a $150 million common stock offering. These moves are expected to enhance Mineralys' financial position and operational flexibility.
Read more →MLYS▼ -13.1%on this newsshared move
Mineralys Therapeutics Announces Pricing of $150 Million Underwritten Offering of Common Stock
Mineralys Therapeutics has announced the pricing of an underwritten offering of 5,660,378 shares at $26.50 each, aiming to raise approximately $150 million. The proceeds will be used to fund a $200 million upfront payment for repurchasing a royalty obligation. The offering is expected to close on June 4, 2026, pending customary conditions.
Read more →MLYSMineralys Therapeutics Presents New Data from the Phase 3 Launch-HTN Trial of Lorundrostat in Participants with Hypertension and Chronic Kidney Disease at European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)
Mineralys Therapeutics presented new data from the Phase 3 Launch-HTN trial at ESH 2026, showing that lorundrostat significantly reduces blood pressure and urine albumin-to-creatinine ratio in patients with chronic kidney disease. The treatment demonstrated a favorable safety profile and comparable efficacy in both CKD and non-CKD participants. Lorundrostat is currently under FDA review with a target decision date of December 22, 2026.
Read more →MLYSMineralys Therapeutics to Participate in the Jefferies Global Healthcare Conference
Mineralys Therapeutics, a biopharmaceutical company, will participate in the Jefferies 2026 Global Healthcare Conference from June 2-4, 2026. The conference will take place in New York, and a live webcast of the presentation will be available on their website. The company specializes in treatments for hypertension and related comorbidities.
Read more →MLYSMineralys Therapeutics Announces Presentation of New Data from the Phase 3 Launch-HTN Trial of Lorundrostat at the 35th European Meeting on Hypertension and Cardiovascular Protection (ESH 2026)
Mineralys Therapeutics has announced the upcoming oral presentation of new data from its Phase 3 Launch-HTN trial of lorundrostat. The presentation will take place at the 35th European Meeting on Hypertension and Cardiovascular Protection in Gdańsk, Poland, from May 28-31, 2026. The trial's results focus on the efficacy and safety of lorundrostat in patients with uncontrolled hypertension and chronic kidney disease (CKD). The company's findings suggest that lorundrostat may effectively reduce systolic blood pressure in this patient population, emphasizing the importance of addressing dysregulated aldosterone.
Read more →MLYSMineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
Mineralys Therapeutics reported its Q1 2026 financial results, highlighting the FDA's acceptance of the NDA for lorundrostat, aimed at treating hypertension. The company has sufficient cash reserves to fund operations into 2028. Despite a net loss of $39.3 million, the firm is optimistic about lorundrostat's potential as a leading treatment option.
Read more →MLYSMineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4)
Mineralys Therapeutics, Inc. has announced inducement stock option and restricted stock unit awards for new employees, covering a total of 52,080 shares. These awards are part of the company’s 2025 Employment Inducement Incentive Award Plan and aim to attract talent as part of their strategic growth. The vesting schedule is structured over a four-year period, promoting employee retention and commitment. Mineralys continues to focus on developing innovative medicines targeting hypertension and related health conditions.
Read more →MLYSMineralys Therapeutics to Participate in the Bank of America Securities Health Care Conference
Mineralys Therapeutics, a biopharmaceutical company, will participate in the Bank of America Securities 2026 Health Care Conference from May 11-14, 2026. The conference will feature a live webcast of a fireside chat with the management team. Mineralys is focused on developing medicines for hypertension and related comorbidities.
Read more →MLYSMineralys Therapeutics to Announce First Quarter 2026 Financial Results and Host Conference Call on Wednesday, May 6, 2026
Mineralys Therapeutics, a biopharmaceutical company, will announce its financial results for Q1 2026 on May 6, 2026. The company focuses on developing treatments for hypertension and related conditions. A live webcast of the conference call will be available on their website, enhancing investor communication.
Read more →MLYSMineralys Therapeutics Appoints Jeffrey A. Munsie as Chief Legal Officer
Mineralys Therapeutics has appointed Jeffrey A. Munsie as Chief Legal Officer, bringing nearly 25 years of legal experience in the biopharma sector. His previous roles include Chief Legal Officer at Orbital Therapeutics. Munsie expressed excitement about joining the company during a pivotal time and aims to advance the development of lorundrostat, a key product candidate.
Read more →MLYSMineralys Therapeutics Reports Fourth Quarter 2025 Financial Results and Provides Corporate Update
Mineralys Therapeutics reported its fourth quarter 2025 financial results and announced the FDA's acceptance of its NDA for lorundrostat, targeting hypertension. The company highlighted significant clinical progress, including successful trials demonstrating the drug's efficacy in reducing blood pressure. Despite a net loss of $154.7 million, Mineralys ended the year with a strong cash position to support future operations.
Read more →MLYSMineralys Therapeutics to Announce Fourth Quarter and Full Year 2025 Financial Results and Host Conference Call on Thursday, March 12, 2026
Mineralys Therapeutics will announce its financial results for Q4 and the full year 2025 on March 12, 2026. The results will be shared after market close, followed by a conference call accessible via a live webcast. The company specializes in treatments for hypertension and related conditions.
Read more →MLYSMineralys Therapeutics Announces FDA Acceptance of NDA for Lorundrostat for Treatment of Adults with Hypertension and Topline Explore-OSA Trial Results - The FDA assigned a PDUFA target action date of
Mineralys Therapeutics announced the FDA's acceptance of their New Drug Application for lorundrostat, aimed at treating adults with hypertension. This follows positive data from clinical trials indicating effective blood pressure reduction and a favorable safety profile. Although the Explore-OSA trial did not significantly reduce the apnea-hypopnea index, it still showed clinically meaningful blood pressure reductions. The FDA has set a target action date of December 22, 2026, signaling a pivotal moment for the company's development in addressing uncontrolled hypertension.
Read more →MLYS▼ -6.4%on this news
Mineralys Therapeutics Reports Inducement Awards Under Nasdaq Listing Rule 5635(c)(4) - February 11, 2026
Mineralys Therapeutics announced the granting of inducement stock option and restricted stock unit awards to two new non-executive employees. The awards, covering a total of 58,632 shares, are part of the company's 2025 Employment Inducement Incentive Award Plan. This initiative aims to attract talent as Mineralys continues to focus on developing treatments for hypertension and related comorbidities.
Read more →MLYSMineralys Therapeutics Provides Corporate Update and Announces Participation in Upcoming LifeSci Partners Corporate Access Event in January 2026 RADNOR, PA
Mineralys Therapeutics has issued a corporate update highlighting recent advancements and upcoming milestones in the development of lorundrostat, their primary drug candidate targeting hypertension and related conditions. The company has filed a New Drug Application with the FDA and completed several successful clinical trials, including positive results from the Explore-CKD and pivotal Launch-HTN trials. Management will also participate in the LifeSci Partners Corporate Access event in January 2026, where further insights into lorundrostat's performance are anticipated.
Read more →MLYSMineralys Therapeutics’ Phase 3 Launch-HTN Trial of Lorundrostat Recognized in Inaugural Journal of the American Medical Association (JAMA) “Research of the Year” Roundup
Mineralys Therapeutics' Phase 3 Launch-HTN trial of lorundrostat was recognized in JAMA's inaugural 'Research of the Year Roundup' for its significant impact on uncontrolled hypertension. The trial showcased lorundrostat's potential in reducing systolic blood pressure when added to existing treatments, highlighting a novel mechanism of action that targets aldosterone production. The trial recruited a diverse population and reported a favorable safety profile, emphasizing the clinical need for innovative treatments in this area.
Read more →MLYSMineralys Therapeutics Reports Inducement Award Under Nasdaq Listing Rule 5635(c)(4)
Mineralys Therapeutics, Inc. has announced the grant of an inducement stock option award covering 146,000 shares to a new non-executive employee. This award is part of the company's 2025 Employment Inducement Incentive Award Plan and will vest over four years, promoting employee retention. This initiative aligns with Nasdaq Listing Rule 5635(c)(4) and shows the company's dedication to strengthening its workforce while it develops treatments for hypertension and related conditions.
Read more →MLYS▲ +5.9%on this news
Mineralys Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update
Mineralys Therapeutics reported its third quarter 2025 financial results, highlighting plans to submit a New Drug Application for lorundrostat by early 2026. The company completed enrollment in the Explore-OSA trial, with topline results expected in Q1 2026. Financially, Mineralys holds $593.6 million in cash, sufficient to fund operations until 2028.
Read more →MLYS▲ +17%on this newsshared move
Data for Lorundrostat in Chronic Kidney Disease and Hypertension Presented at American Society of Nephrology (ASN) Kidney Week 2025
Mineralys Therapeutics presented promising clinical data for lorundrostat at ASN Kidney Week 2025. The Phase 2 Explore-CKD trial demonstrated significant reductions in blood pressure and albuminuria in patients with chronic kidney disease. Additionally, the pivotal Phase 3 Launch-HTN trial was recognized for its efficacy in managing uncontrolled hypertension. These results position lorundrostat favorably for a potential FDA New Drug Application submission.
Read more →MLYS▼ -6.7%on this news· ran to +19% by day 3shared move
Mineralys Therapeutics to Participate in Upcoming Investor Conferences
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will participate in several upcoming investor conferences. Senior management will engage in fireside chats to discuss their innovative approaches to treating hypertension and related conditions. Their lead product candidate, lorundrostat, targets aldosterone dysregulation, highlighting the company's commitment to addressing critical health challenges.
Read more →MLYSMineralys Therapeutics to Announce Third Quarter 2025 Financial Results and Host Conference Call on Monday, November 10, 2025
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has announced that it will release its financial results for the third quarter of 2025 on November 10, 2025. The results will be available after the market closes, followed by a conference call for investors. The company specializes in developing treatments for hypertension and comorbidities, with a focus on its candidate product, lorundrostat. A live webcast of the call will also be accessible through their Investor Relations website.
Read more →MLYSMineralys Therapeutics Announces Late-Breaking Presentation of Phase 2 Explore-CKD Trial of Lorundrostat at American Society of Nephrology (ASN) Kidney Week 2025
Mineralys Therapeutics announced that data from its Phase 2 Explore-CKD trial of lorundrostat will be presented at the ASN Kidney Week 2025. The trial evaluates lorundrostat's safety and efficacy in patients with hypertension and chronic kidney disease. Additionally, data from the Phase 3 Launch-HTN trial will also be showcased during the event, highlighting the company's focus on addressing hypertension-related conditions.
Read more →MLYSMineralys Therapeutics Completes Enrollment in Phase 2 EXPLORE-OSA Trial of Lorundrostat in Obstructive Sleep Apnea and Hypertension
Mineralys Therapeutics has completed participant enrollment in its Phase 2 EXPLORE-OSA trial, which evaluates lorundrostat for treating obstructive sleep apnea and hypertension. The trial aims to assess the efficacy and safety of lorundrostat, with top-line results expected in the first quarter of 2026. This development is crucial for expanding treatment options for patients with these comorbidities.
Read more →MLYS▲ +5.1%on this news· ran to +16% by day 3
Mineralys Therapeutics Presents Subgroup Analyses of Phase 3 Launch-HTN Trial Demonstrating Efficacy and Safety of Lorundrostat in Hypertension Participants with High Unmet Medical Need
Mineralys Therapeutics presented new subgroup analyses from the Phase 3 Launch-HTN trial, highlighting the efficacy and safety of lorundrostat in treating hypertension among high-risk populations. The trial demonstrated significant blood pressure reductions across diverse subgroups, including older adults and those with obesity. The favorable safety profile reinforces lorundrostat's potential as a transformative treatment for uncontrolled hypertension.
Read more →MLYS▲ +5.1%on this news· ran to +16% by day 3shared move
Mineralys Therapeutics Announces Closing of Upsized $287.5 Million Underwritten Public Offering of Common Stock Including Full Exercise of Underwriters’ Option to Purchase Additional Shares
Mineralys Therapeutics has successfully closed an upsized public offering, raising approximately $287.5 million by selling 11,274,509 shares of common stock at $25.50 each. The proceeds will be used to support the clinical development of lorundrostat, along with other corporate purposes. The offering was managed by several prominent financial institutions.
Read more →MLYSMineralys Therapeutics Announces Pricing of Upsized $250.0 Million Underwritten Public Offering of Common Stock
Mineralys Therapeutics has announced the pricing of an upsized public offering of 9,803,921 shares at $25.50 each, aiming to raise approximately $250 million. The proceeds will be utilized for the clinical development of lorundrostat and other corporate purposes. The offering is expected to close around September 4, 2025.
Read more →MLYSMineralys Therapeutics Announces Proposed Public Offering of Common Stock
Mineralys Therapeutics has announced a proposed public offering of $175 million in common stock to support the clinical development of its hypertension treatment, lorundrostat. The company may also allow underwriters to purchase an additional $26.25 million in shares. The offering is contingent on market conditions and is part of a broader strategy to fund research and general corporate purposes.
Read more →MLYSMineralys Therapeutics Reports Second Quarter 2025 Financial Results and Provides Corporate Update - Presented and published the positive results from both the Launch-HTN and Advance-HTN pivotal trials at scientific meet
Mineralys Therapeutics has reported its second quarter 2025 financial results, highlighting positive outcomes from pivotal trials for lorundrostat in treating uncontrolled hypertension. Both the Launch-HTN and Advance-HTN trials met their primary endpoints, affirming the drug's efficacy and safety profile. The company is preparing for a pre-NDA meeting with the FDA in the fourth quarter of 2025, while also reporting a net loss of $43.3 million for the quarter. Despite the financial loss, Mineralys demonstrated strong cash reserves that will support ongoing clinical trials and operations into 2027.
Read more →MLYSMineralys Therapeutics to Announce Second Quarter 2025 Financial Results and Host Conference Call on Tuesday, August 12, 2025
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, is set to announce its financial results for the second quarter of 2025 on August 12, 2025, following the market's closure. The announcement emphasizes the company's commitment to addressing hypertension and related health issues. Investors can join a conference call to discuss the results, with details provided in the release.
Read more →MLYSMineralys Therapeutics Announces Journal of the American Medical Association (JAMA) Publication of Pivotal Phase 3 Launch-HTN Trial for Lorundrostat
Mineralys Therapeutics has published positive results from its pivotal Phase 3 Launch-HTN trial in the Journal of the American Medical Association. The trial, which involved 1,083 participants with uncontrolled or treatment-resistant hypertension, indicated that lorundrostat significantly reduced systolic blood pressure after 6 and 12 weeks of treatment. The drug demonstrated a favorable safety profile, with mostly mild and transient adverse events reported. This publication highlights the potential of lorundrostat as a best-in-class treatment option for hypertension, particularly for patients not adequately managed by existing therapies.
Read more →MLYSMineralys Therapeutics Announces Positive Topline Results from Phase 2 Explore-CKD Trial of Lorundrostat for the Treatment of Hypertension in Subjects with CKD and Albuminuria - Explore-CKD met its primary endpoint lorun
Mineralys Therapeutics reported positive topline results from its Phase 2 Explore-CKD trial, demonstrating that lorundrostat significantly reduced systolic blood pressure and urine albumin-to-creatinine ratio in patients with chronic kidney disease and hypertension. The trial met its primary endpoint, achieving a 9.3 mmHg reduction in systolic BP compared to placebo. Lorundrostat also exhibited a favorable safety profile, with few treatment-emergent adverse events. These findings enhance the evidence supporting lorundrostat's potential in treating hypertension and related kidney issues.
Read more →MLYSMineralys Therapeutics Announces Late-Breaking Presentation of Data from the Launch-HTN Pivotal Trial of Lorundrostat in Uncontrolled or Resistant Hypertension at 34th European Meeting on Hypertension and Cardiovascular Protection (ESH 2025)
Mineralys Therapeutics presented results from the pivotal Phase 3 Launch-HTN trial of lorundrostat, showing significant efficacy for patients with uncontrolled or resistant hypertension. In over 1,000 participants, lorundrostat 50 mg demonstrated clinically meaningful reductions in systolic blood pressure at both Week 6 and Week 12. The trial also highlighted the drug's favorable safety and tolerability profile, positioning lorundrostat as a promising new option for managing hypertension. These results were announced at the 34th European Meeting on Hypertension and Cardiovascular Protection.
Read more →MLYS▲ +5.1%on this news
Mineralys Therapeutics Announces Late-Breaking Presentation of Phase 3 Launch-HTN Trial at 34th European Meeting on Hypertension and Cardiovascular Protection
Mineralys Therapeutics announced a late-breaking presentation of data from its Phase 3 Launch-HTN trial, which evaluates lorundrostat for treating uncontrolled and resistant hypertension. The presentation will take place at the 34th European Meeting on Hypertension and Cardiovascular Protection in Milan. Lorundrostat has previously demonstrated significant efficacy in reducing plasma aldosterone levels and blood pressure in a Phase 2 trial. However, there are safety concerns regarding potential side effects and the dependency on trial outcomes for future development.
Read more →MLYSMineralys Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update - Pivotal Advance-HTN and Launch-HTN trials successfully achieved statistical significance in primary efficacy endpoints a
Mineralys Therapeutics reported positive results for its pivotal clinical trials, Advance-HTN and Launch-HTN, demonstrating lorundrostat's efficacy in treating uncontrolled hypertension. The company also announced upcoming trial data from Explore-CKD and initiation of the Explore-OSA trial. Financial results for Q1 2025 showed a net loss rise, but a strong cash position of $343 million supports upcoming clinical efforts. Management is optimistic about future regulatory submissions and the commercial potential of lorundrostat.
Read more →MLYSMineralys Therapeutics to Announce First Quarter 2025 Financial Results and Host Conference Call on Monday, May 12, 2025
Mineralys Therapeutics, Inc. has announced that it will report its financial results for the first quarter of 2025 on May 12, 2025, following the close of financial markets. The company specializes in developing treatments for conditions influenced by aldosterone dysregulation, including hypertension and chronic kidney disease. A conference call will be hosted on the same date to discuss these results. Interested parties can participate via phone or webcast.
Read more →MLYSMineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
Mineralys Therapeutics has announced the publication of pivotal Phase 2 Advance-HTN trial results in the New England Journal of Medicine, highlighting the efficacy of lorundrostat for patients with uncontrolled hypertension. The trial demonstrated a significant reduction in 24-hour ambulatory blood pressure and showed promise in both male and female patients, as well as across different racial groups. These findings support the role of dysregulated aldosterone in hypertension, indicating lorundrostat may provide a much-needed treatment option. Additional data from a Phase 3 trial will be presented at an upcoming medical conference.
Read more →MLYS▲ +8.3%on this news
Mineralys Therapeutics Announces Late-Breaking Data from Advance-HTN Pivotal Trial of Lorundrostat in Uncontrolled and Resistant Hypertension Presented at the American College of Cardiology's Annual Scientific Session Ex
Mineralys Therapeutics presented late-breaking data from the Advance-HTN pivotal trial of lorundrostat at the American College of Cardiology's Annual Scientific Session. The trial demonstrated a 15.4 mmHg absolute reduction in blood pressure for patients taking lorundrostat, along with a favorable safety profile. This data supports lorundrostat's potential as a best-in-class treatment for uncontrolled and resistant hypertension, particularly for patients typically treated in specialist settings. The results are significant as they capture a diverse patient population historically underrepresented in hypertension trials.
Read more →MLYSMineralys Therapeutics to Host KOL Call to Discuss Clinical Data from Launch-HTN and Advance-HTN Pivotal Trials Tuesday, April 1, 2025, at 8:00 AM ET
Mineralys Therapeutics, Inc. announced a conference call and webinar scheduled for April 1, 2025, to discuss the results from its pivotal clinical trials, Advance-HTN and Launch-HTN. Dr. Luke Laffin of the Cleveland Clinic will provide insights on the persistent medical needs in resistant hypertension and the implications of lorundsrostat as a potential treatment. The call underscores Mineralys' commitment to addressing hypertension and related conditions.
Read more →MLYS▲ +8.5%on this news· ran to +19% by day 3
Mineralys Therapeutics Announces Closing of Underwriters’ Option to Purchase Additional Shares in Connection with Public Offering of Common Stock
Mineralys Therapeutics has successfully completed a public offering, closing the sale of an additional 1,944,444 shares at $13.50 each, totaling approximately $201.2 million in gross proceeds. The funds will be allocated toward the clinical development of its lead candidate, lorundrostat, focusing on research, manufacturing, and pre-commercial activities. The underwriters for this offering included prominent financial institutions such as BofA Securities and Goldman Sachs. This move significantly bolsters the company's financial resources for pursuing its development goals.
Read more →MLYSMineralys Therapeutics Announces Data from the Phase 2 Advance-HTN Trial of Lorundrosat for the Treatment of Hypertension Has Been Accepted as a Late-Breaking Presentation at the 2025 American College of Cardiology’s Annual Scientific Session & Expo
Mineralys Therapeutics announced that data from its Phase 2 Advance-HTN trial on lorundrostat for uncontrolled hypertension has been accepted for a late-breaking presentation at the American College of Cardiology's Annual Scientific Session & Expo in March 2025. Lorundrostat, a selective aldosterone synthase inhibitor, demonstrated clinically meaningful blood pressure reductions in earlier trials. The session presentation is expected to bolster awareness and interest in the company's innovative approach to treating hypertension and related conditions. However, there are some risks highlighted, including possible adverse effects and regulatory uncertainties surrounding the drug's development and approval process.
Read more →MLYS▼ -8.3%on this newsshared move
Mineralys Therapeutics Announces Pricing of $175.0 Million Underwritten Public Offering of Common Stock
Mineralys Therapeutics has announced the pricing of a public offering of 12,962,962 shares at $13.50 per share, expected to raise approximately $175.0 million. These proceeds will be used to fund the clinical development of lorundrostat, along with research, manufacturing, and working capital. The offering is expected to close around March 13, 2025, pending customary conditions. Key financial firms are involved as underwriters for this public offering.
Read more →MLYS▲ +42.2%on this newsshared move
Mineralys Therapeutics Announces Positive Topline Results from Launch-HTN and Advance-HTN Pivotal Trials of Lorundrostat for the Treatment of Uncontrolled or Resistant Hypertension - Launch-HTN met its primary endpoint w
Mineralys Therapeutics reported positive topline results from the Launch-HTN and Advance-HTN pivotal trials of lorundrostat, targeting uncontrolled hypertension. The Launch-HTN trial showed a statistically significant reduction in systolic blood pressure, meeting all predefined primary endpoints. Similarly, Advance-HTN achieved its primary endpoint, indicating the drug's efficacy. Both trials demonstrated a favorable safety and tolerability profile, leading to optimism about lorundrostat's potential regulatory approval and market value.
Read more →MLYS▲ +42.2%on this newsshared move
Mineralys Therapeutics Announces Proposed Public Offering of Common Stock RADNOR, PA
Mineralys Therapeutics has announced a proposed public offering of $250 million of common stock to fund clinical development and commercialization activities related to its product lorundrostat. The offering includes a potential additional $37.5 million option for underwriters. Major financial institutions, including BofA Securities and Goldman Sachs, are involved in this underwritten offering, signaling a significant investment interest. However, market conditions could affect the actual completion and terms of the offering.
Read more →MLYSMineralys Therapeutics to Announce Topline Data from Launch-HTN and Advance-HTN Pivotal Trials Monday, March 10, 2025, at 8:00 AM ET
Mineralys Therapeutics, Inc. will announce topline results from its pivotal trials, Launch-HTN and Advance-HTN, on March 10, 2025. The trials investigate lorundrostat, a selective aldosterone inhibitor, for treating uncontrolled hypertension as an add-on therapy. The company aims to address hypertension and other cardiorenal conditions driven by dysregulated aldosterone. The announcement will be made via a conference call and webcast, ensuring transparency with stakeholders.
Read more →MLYS▲ +10%on this news
Mineralys Therapeutics Reports Fourth Quarter and Full Year 2024 Financial Results and Provides Corporate Update - Anticipate topline data from pivotal Advance-HTN trial in March 2025 and pivotal Phase 3 Launch-HTN trial
Mineralys Therapeutics reported its financial results for Q4 and full year 2024, alongside a corporate update highlighting pivotal trials for its candidate lorundrostat. The company anticipates topline data from its Advance-HTN trial in March 2025 and a subsequent Launch-HTN trial in the first half of 2025. Additionally, enrollment for the Explore-CKD Phase 2 trial is complete, with expected data release in Q2 2025. Despite substantial cash reserves, the company is facing increasing R&D expenses and notable net losses from the previous year.
Read more →MLYSMineralys Therapeutics to Announce Fourth Quarter and Full Year 2024 Financial Results and Host Conference Call on Wednesday, February 12, 2025
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will announce its fourth quarter and full year 2024 financial results on February 12, 2025. The company specializes in developing medicines for health conditions driven by dysregulated aldosterone, including hypertension and chronic kidney disease. A conference call will follow the announcement, offering insights into the company's performance. This event underscores Mineralys's commitment to transparency and engagement with its investors.
Read more →MLYSMineralys Therapeutics Completes Enrollment in Explore-CKD Phase 2 Trial of Lorundrostat for the Treatment of Hypertension in Subjects with Stage 2 to 3b CKD and Albuminuria - Continues to anticipate announcing topline d
Mineralys Therapeutics has announced the completion of enrollment in the Explore-CKD Phase 2 trial, which is evaluating lorundrostat for treating hypertension in patients with Stage 2 to 3b CKD and albuminuria. The company intends to release topline data from the trial in the second quarter of 2025. This trial adds to the company's ongoing research initiatives targeting high-risk hypertension patients. Lorundrostat is particularly focused on patients whose conditions remain poorly controlled despite existing treatments.
Read more →MLYS▼ -13.7%on this news· ran to -30% by day 3
Mineralys Therapeutics Announces Phase 2 Clinical Trial of Lorundrostat for Obstructive Sleep Apnea in Patients with Hypertension - Estimated 54 million people suffer from obstructive sleep apnea in the U.S. including 30
Mineralys Therapeutics has announced the initiation of a Phase 2 clinical trial for lorundrostat, aimed at treating moderate-to-severe obstructive sleep apnea in hypertensive patients. The FDA has approved the necessary IND application, and the company expects to start the trial in Q1 2025. This trial aligns with Mineralys' strategy to target diseases influenced by dysregulated aldosterone. The study will compare lorundrostat's efficacy against placebo and assess its potential in mitigating the severity of obstructive sleep apnea and nocturnal hypertension.
Read more →MLYS▲ +6.3%on this news
Mineralys Therapeutics Reports Third Quarter 2024 Financial Results and Provides Corporate Update - Completed enrollment in pivotal Advance-HTN trial and anticipate topline data in March 2025 - - Completed enrollment ahe
Mineralys Therapeutics has reported its third-quarter financial results for 2024, highlighting the completion of enrollment in pivotal trials for its hypertension treatment, lorundrostat. The company expects to deliver topline data from these trials in the first half of 2025, which is seen as pivotal for future FDA submissions. Despite a significant increase in net losses, the company maintains a strong cash position, estimating sufficient funding for its clinical studies through 2026.
Read more →MLYSMineralys Therapeutics to Announce Third Quarter 2024 Financial Results and Host Conference Call on Monday, November 11, 2024
Mineralys Therapeutics, a clinical-stage biopharma company, announced it will report its third quarter 2024 financial results on November 11, 2024, after market close. The company specializes in medicines targeting hypertension and chronic kidney disease, driven by dysregulated aldosterone. A conference call with investors will follow the financial results announcement, allowing further discussion about the company's progress and future plans.
Read more →MLYSMineralys Therapeutics Completes Enrollment Ahead of Schedule in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension - Topline data now anticipated in mid first half of 2025 - - Managem
Mineralys Therapeutics has successfully completed enrollment ahead of schedule for the Launch-HTN trial, which evaluates lorundrostat as a treatment for uncontrolled hypertension. The company anticipates topline data from the trial to be available in the first half of 2025. This pivotal trial focuses on patients who have not achieved their blood pressure goals with existing medications. A virtual event is scheduled to discuss the ongoing clinical program and the unmet needs in hypertension treatment.
Read more →MLYSMineralys to Host Virtual KOL Event on the Unmet Medical Need in Uncontrolled and Resistant Hypertension, and Lorundrostat as a Potential Treatment on October 30, 2024
Mineralys Therapeutics announced a virtual event scheduled for October 30, 2024, focusing on the unmet medical need in uncontrolled and resistant hypertension. Key opinion leaders will discuss the potential impact of lorundrostat, a selective aldosterone synthase inhibitor currently under investigation. The event will also overview ongoing pivotal trials like Advance-HTN and Launch-HTN. Preliminary trial results indicate that lorundrostat could significantly aid patients not responding to existing hypertension treatments.
Read more →MLYSMineralys Therapeutics Completes Target Enrollment in Pivotal Advance-HTN Trial of Lorundrostat for the Treatment of Hypertension - On track to announce topline data in Q1 2025 - - Virtual KOL event scheduled on October
Mineralys Therapeutics has announced the completion of target enrollment in the pivotal Advance-HTN trial for lorundrostat, aimed at treating uncontrolled and resistant hypertension. A total of 261 subjects have been enrolled, and topline data is anticipated in the first quarter of 2025. The trial is designed to evaluate the drug as an add-on therapy combined with standard antihypertensive treatments. A virtual event on October 30 will discuss hypertension management and the trial's progress.
Read more →MLYSMineralys Therapeutics to Participate in the Wells Fargo Healthcare Conference
Mineralys Therapeutics, a clinical-stage biopharmaceutical company focused on hypertension and chronic kidney disease, will participate in the Wells Fargo Healthcare Conference from September 4-6, 2024. Management will engage in a fireside chat on September 5 at 1:30pm EDT, which will also be available via live webcast. The company aims to promote its work on lorundrostat, a drug candidate targeting conditions driven by dysregulated aldosterone.
Read more →MLYSMineralys Therapeutics Reports Second Quarter 2024 Financial Results and Provides Corporate Update - Advance-HTN trial is approximately 90% enrolled trial is anticipated to deliver topline data in Q1 2025 - - Enrollment
Mineralys Therapeutics has reported its financial results for the second quarter of 2024, highlighting advancements in its clinical trials. The Advance-HTN trial is nearing completion with 90% enrollment, and topline data is expected in Q1 2025. The Launch-HTN trial is also on track for data delivery in 2H 2025. Despite a significant increase in net loss and R&D expenses, the company maintains a strong cash position to support ongoing clinical programs.
Read more →MLYS▼ -5.7%on this news
Mineralys Therapeutics to Announce Second Quarter 2024 Financial Results and Host Conference Call on Tuesday, August 13, 2024
Mineralys Therapeutics has announced that it will report its financial results for the second quarter of 2024 on August 13, 2024, after market close. The company focuses on developing medicines targeting hypertension and chronic kidney disease. A conference call is scheduled for the same day, and will be available via a live webcast. Mineralys is known for its lead candidate, lorundrostat, aimed at addressing cardiorenal conditions affected by aldosterone dysregulation.
Read more →MLYSMineralys Therapeutics Appoints Biopharmaceutical Executive Alexander M. Gold, M.D. to its Board of Directors
Mineralys Therapeutics has appointed Dr. Alexander M. Gold to its Board of Directors, effective June 13, 2024. Dr. Gold, a cardiologist with over 20 years of biopharmaceutical experience, will contribute to the late-stage clinical development of lorundrostat, targeting hypertension and related conditions. The company also announced the resignation of Dr. Olivier Litzka, thanking him for his contributions. Lorundrostat is an investigational therapy showing significant promise in treating uncontrolled hypertension, though its development faces regulatory and safety challenges.
Read more →MLYSMineralys Therapeutics to Participate in the Goldman Sachs 45th Annual Global Healthcare Conference
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has announced its participation in the Goldman Sachs 45th Annual Global Healthcare Conference scheduled for June 10-13, 2024, in Miami, FL. The company's management will engage in a fireside chat on June 11, 2024, at 4:00 PM EDT. This event aims to enhance visibility and interaction with investors and stakeholders regarding its focus on developing treatments for hypertension and chronic kidney disease, among other conditions driven by dysregulated aldosterone.
Read more →MLYSMineralys Therapeutics Reports First Quarter 2024 Financial Results and Provides Corporate Update - Advance-HTN trial of lorundrostat for the treatment of uHTN or rHTN is anticipated to deliver topline data in Q4 2024 -
Mineralys Therapeutics has reported its first-quarter financial results for 2024, highlighting significant progress in its clinical trials for lorundrostat, aimed at treating uncontrolled hypertension and chronic kidney disease. The company anticipates topline data from the Advance-HTN trial in Q4 2024 and the Launch-HTN trial in 2H 2025. Financially, Mineralys boasts $338.6 million in cash but reported a net loss increase, raising concerns about future expenses. Overall, there's optimism about lorundrostat's potential impact in treating hypertension and related conditions.
Read more →MLYSMineralys Therapeutics to Announce First Quarter 2024 Financial Results and Host Conference Call on Thursday, May 9, 2024
Mineralys Therapeutics, Inc. has announced it will report its financial results for the first quarter of 2024 on May 9, 2024. The conference call will occur at 8:30 a.m. ET, with a live webcast available for participants. The company focuses on developing treatments for hypertension and chronic kidney disease, with an emphasis on their clinical-stage product candidate, lorundrostat. They are based in Radnor, Pennsylvania and are actively engaging with investors and stakeholders through conference calls.
Read more →MLYSMineralys Therapeutics Reports Fourth Quarter and Full Year 2023 Financial Results and Provides Corporate Update - Enrollment in the two pivotal trials of lorundrostat for the treatment of uHTN or rHTN is on track, with
Mineralys Therapeutics has reported its financial results for Q4 and the full year 2023, highlighting notable progress in clinical trials for lorundrostat, aimed at treating hypertension. Enrollment in pivotal trials is on schedule, with topline data anticipated in Q4 2024 and 2H 2025. The company also completed a successful private placement financing, boosting its financial position. However, it faced an increased net loss of $71.9 million for the year, attributed to rising research and development expenses.
Read more →MLYSMineralys Therapeutics to Announce Fourth Quarter and Full Year 2023 Financial Results and Host Conference Call on Thursday, March 21, 2024
Mineralys Therapeutics, Inc. will disclose its fourth quarter and full-year financial results for 2023 on March 21, 2024, prior to market opening. The announcement highlights the company’s focus on developing treatments for hypertension and chronic kidney disease. Participants can join the conference call using specific dial-in information and access a live webcast. Mineralys is noted for its product candidate, lorundrostat, targeting cardiorenal conditions related to elevated aldosterone levels.
Read more →MLYS▲ +12.5%on this news
Mineralys Therapeutics Announces $120 Million Private Placement Financing RADNOR, Pa.
Mineralys Therapeutics has announced a $120 million private placement financing to enhance its development efforts for lorundrostat, targeting conditions linked to elevated aldosterone. The funding, led by TCGX and supported by existing investors such as RA Capital Management, will support research and general corporate purposes. The private placement is set to close on February 12, 2024, contingent upon customary closing conditions. This financing comes as Mineralys continues to focus on treatments for hypertension and chronic kidney disease.
Read more →MLYS▲ +6.2%on this news· ran to +23% by day 3
Mineralys Therapeutics to Participate in the Guggenheim Securities 6th Annual Biotechnology Conference
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, announced that 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 event aims to highlight the company's efforts in developing treatments for hypertension and chronic kidney disease. A live webcast of the chat will be available on their Investor Relations website, with a replay accessible for 90 days following the event. Mineralys is focused on their proprietary product candidate, lorundrostat, which targets diseases driven by elevated aldosterone levels.
Read more →MLYSMineralys Therapeutics Appoints Minji Kim, Ph.D. as Chief Business Officer RADNOR, PA
Mineralys Therapeutics has appointed Dr. Minji Kim as Chief Business Officer as part of an organizational restructuring. This decision allows the company to enhance its focus on its late-stage clinical development of lorundrostat, which targets hypertension and chronic kidney disease. Dr. Kim brings significant experience in business development and strategic leadership, and the company anticipates several clinical milestones for lorundrostat in the upcoming months. The addition of Dr. Kim is seen as a positive step forward for the company as it continues to develop treatments for diseases related to elevated aldosterone levels.
Read more →MLYSMineralys Therapeutics Announces First Subject Dosed in Launch-HTN, the Second Pivotal Trial of Lorundrostat for the Treatment of Hypertension - Topline data from confirmatory Launch-HTN trial expected in 2H 2025 - - Top
Mineralys Therapeutics has announced the dosing of the first subject in the Launch-HTN pivotal trial, the second essential study evaluating the efficacy of lorundrostat for treating uncontrolled hypertension. This initiative aims to assess lorundrostat as an add-on therapy for patients not achieving their blood pressure goals with existing treatments. The company anticipates topline results from its first pivotal trial, Advance-HTN, in the second half of 2024, highlighting ongoing progress toward addressing hypertension through targeted therapies. However, challenges related to clinical trial timelines and regulatory approvals remain a concern.
Read more →MLYSMineralys Therapeutics Further Defines Endotype-Specific, Targeted Approach to Treatment of Uncontrolled or Resistant Hypertension with Lorundrostat Data at AHA Scientific Sessions 2023 - New analysis on serum leptin lev
Mineralys Therapeutics presented new findings on lorundrostat at the AHA Scientific Sessions 2023, highlighting its potential for treating uncontrolled hypertension, particularly in obese patients. Data from the Target-HTN Phase 2 trial indicated that higher serum leptin levels, associated with increased BMI, could serve as a biomarker for responsiveness to lorundrostat treatment. The study underscores the importance of targeted therapies tailored to specific hypertension endotypes. This research could influence clinical practices in managing resistant hypertension and improve outcomes for affected patients.
Read more →MLYS▼ -9.3%on this news· ran to -21% by day 1shared move
Mineralys Therapeutics to Participate in Three Upcoming Conferences
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will participate in three upcoming conferences: the Stifel Healthcare Conference in New York, the Jefferies London Healthcare Conference, and the Evercore ISI 6th Annual HealthCONx Conference in Miami. These events are scheduled for mid to late November 2023. Their participation is expected to highlight their focus on developing treatments for hypertension and chronic kidney disease. A live webcast of the presentations will be available on their website.
Read more →MLYS▲ +8%on this news· ran to -20% by day 3shared move
Mineralys Therapeutics Reports Third Quarter 2023 Financial Results and Provides Corporate Update - On track to initiate planned Phase 3 pivotal Launch-HTN trial of lorundrostat to treat patients with uncontrolled or res
Mineralys Therapeutics reported significant advancements in its clinical programs during Q3 2023, including plans to initiate two pivotal trials for lorundrostat targeting uncontrolled hypertension and chronic kidney disease. The company's financial performance reflects a cash reserve increase to approximately $265.9 million, although it also posted a net loss of $22.8 million for the quarter. Among notable accomplishments, the publication of the Target-HTN trial results in JAMA and presentations at ASN's Kidney Week underscore lorundrostat's potential efficacy. Upcoming milestones include the anticipated initiation of the Launch-HTN trial by the end of 2023.
Read more →MLYSMineralys Therapeutics Presents New Post-Hoc Analysis from Target-HTN Phase 2 Trial of Lorundrostat in Late-Breaking Poster Session at ASN Kidney Week 2023 Meeting - Analysis further supports obesity-associated dysregula
Mineralys Therapeutics presented a post-hoc analysis from its Target-HTN Phase 2 trial at ASN Kidney Week 2023, highlighting the effectiveness of lorundrostat in patients with uncontrolled and treatment-resistant hypertension. The analysis demonstrated a median blood pressure reduction of 32 mmHg among responders, correlating positively with higher BMI. The company is moving forward with its pivotal Advance-HTN trial to further evaluate the hypertensive endotype. Lorundrostat shows promise as a precision medicine approach to treating hypertension linked to obesity.
Read more →MLYSMineralys Therapeutics to Announce Third Quarter 2023 Financial Results and Host Conference Call on Tuesday, November 7, 2023
Mineralys Therapeutics, Inc. has announced that it will report its financial results for the third quarter of 2023 on November 7, 2023, after market close. The clinical-stage biopharmaceutical company specializes in developing therapies aimed at conditions driven by elevated aldosterone, such as hypertension and chronic kidney disease. The financial report will be followed by a conference call, which will also be available via live webcast. This event is anticipated to shed light on the company's performance and future direction.
Read more →MLYS▲ +5.6%on this news
Mineralys Therapeutics Announces Upcoming Poster Presentations at Two Scientific Conferences in November 2023
Mineralys Therapeutics announced upcoming poster presentations at ASN's Kidney Week 2023 and AHA's Scientific Sessions 2023 in November 2023. At ASN, the focus will be on lorundrostat's treatment effects for hypertension, while the AHA presentation will highlight its potential for obesity-related hypertension. These presentations aim to showcase lorundrostat's therapeutic value and may attract further clinical attention.
Read more →MLYSMineralys Therapeutics Expands its Board of Directors with Appointments of Glenn Sblendorio and Daphne Karydas
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has appointed Glenn Sblendorio and Daphne Karydas to its Board of Directors. Both individuals bring extensive experience in biotechnology and biopharmaceuticals, which is expected to offer strong support in developing novel medicines for hypertension and chronic kidney disease. Additionally, the company announced that Takeshi Takahashi has stepped down from the Board. These changes signal Mineralys's commitment to enhancing its leadership and expertise in the life sciences sector.
Read more →MLYSMineralys Therapeutics to Participate in the Cantor Fitzgerald Global Healthcare Conference on Thursday, September 28, 2023
Mineralys Therapeutics, Inc. will participate in the Cantor Fitzgerald Global Healthcare Conference on September 28, 2023. CEO Jon Congleton and CFO Adam Levy are scheduled to engage in a fireside chat at 9:10 a.m. ET. The event will be accessible via a live webcast on the company’s website, with a replay available for 90 days. The company specializes in developing medications for hypertension and chronic kidney disease.
Read more →MLYSMineralys Therapeutics Announces JAMA Publication of Full Target-HTN Phase 2 Trial Results for Lorundrostat in Uncontrolled and Treatment-Resistant Hypertension
Mineralys Therapeutics announced the publication of its full results from the Target-HTN Phase 2 trial for lorundrostat, a new aldosterone synthase inhibitor, in patients with uncontrolled and treatment-resistant hypertension. The trial demonstrated significant reductions in systolic blood pressure, especially in individuals with elevated body mass index, highlighting the drug's potential as a new treatment option. These promising results have led to plans for a pivotal clinical development program. However, some adverse events were noted, including hyponatremia, and the company faces potential regulatory challenges.
Read more →MLYSMineralys Therapeutics Presents Target-HTN Phase 2 Trial Results in Late-Breaking Science Session at 2023 AHA Hypertension Scientific Sessions
Mineralys Therapeutics recently presented encouraging outcomes from the Target-HTN Phase 2 trial of lorundrostat, an aldosterone synthase inhibitor aimed at treating uncontrolled and resistant hypertension. The trial showed a statistically significant reduction in systolic blood pressure in participants, particularly in those with elevated body mass index. These results were shared at the 2023 AHA Hypertension Scientific Sessions and are anticipated to serve as a foundation for future clinical trials for lorundrostat, including the ongoing Advance-HTN trial projected to report topline data in 2024.
Read more →MLYS▼ -5.6%on this news
Mineralys Therapeutics Selected for Oral Poster Presentation of Target-HTN Phase 2 Trial Results at 2023 AHA Hypertension Scientific Sessions
Mineralys Therapeutics has been selected to present the results of its Target-HTN Phase 2 trial for lorundrostat at the 2023 AHA Hypertension Scientific Sessions. This drug, which targets uncontrolled hypertension by inhibiting aldosterone synthase, demonstrated about a 70% reduction in plasma aldosterone levels. The results will be presented by Dr. Luke Laffin, with the presentation scheduled for September 10. The company cautions that there are various risks and uncertainties associated with the drug's development and regulatory approval processes.
Read more →MLYSMineralys Therapeutics to Participate in the Wells Fargo Securities Healthcare Conference on Thursday, September 7, 2023
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, will participate in the Wells Fargo Securities Healthcare Conference on September 7, 2023. CEO Jon Congleton and CFO Adam Levy will engage in a fireside chat to discuss the company's developments. Mineralys is focused on treating diseases associated with elevated aldosterone, and its lead candidate, lorundrostat, aims to address cardiorenal conditions. The event offers a platform to increase awareness of their innovative treatments.
Read more →MLYS▼ -6%on this news
Mineralys Therapeutics Reports Second Quarter 2023 Financial Results and Provides Corporate Update - Continue enrolling subjects in ongoing pivotal Advance-HTN trial of lorundrostat, for the treatment of patients with un
Mineralys Therapeutics announced its second quarter 2023 financial results, highlighting ongoing enrollment in the pivotal Advance-HTN trial for lorundrostat, aimed at treating uncontrolled hypertension. The company plans to initiate the Phase 3 Launch-HTN trial in the latter half of 2023 and has expanded its Phase 2 trial for patients with chronic kidney disease (CKD). Financially, the company reported a cash position of $282.8 million but also noted a net loss of $12.1 million for the quarter, which raised concerns about future profitability.
Read more →MLYSMineralys Therapeutics to Announce Second Quarter 2023 Financial Results and Host Conference Call on Monday, August 7, 2023
Mineralys Therapeutics, a clinical-stage biopharmaceutical firm, will announce its financial results for Q2 2023 on August 7, 2023, after market close. The company focuses on developing treatments for diseases associated with high levels of aldosterone. The conference call is scheduled for 4:30 p.m. ET, allowing investors and analysts to discuss the results. The company's lead product candidate targets cardiorenal conditions like hypertension and chronic kidney disease.
Read more →MLYSMineralys Therapeutics Announces Expansion of Planned Phase 2 Trial of Lorundrostat Alone and in Combination with SGLT2 Inhibitor to Treat Patients with Chronic Kidney Disease (CKD) - Plan to initiate a Phase 2 proof of
Mineralys Therapeutics has expanded its Phase 2 clinical trial for lorundrostat, targeting patients with Stage 2 to 4 chronic kidney disease (CKD). The trial will evaluate lorundrostat alone and in combination with an SGLT2 inhibitor, aiming to demonstrate safety and efficacy. Enrollment is expected to begin in the latter half of 2023, with results anticipated between Q4 2024 and Q1 2025. This initiative builds upon previous findings that highlight the role of aldosterone in CKD progression.
Read more →MLYSMineralys Therapeutics to Participate in the Jefferies Healthcare Conference
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, announced its participation in the Jefferies Healthcare Conference set for June 9, 2023. CEO Jon Congleton and CFO Adam Levy will present at 9:30 a.m. ET. The company specializes in developing treatments for diseases linked to elevated aldosterone levels, with its primary candidate, lorundrostat, targeting uncontrolled hypertension. The conference serves as an opportunity for the company to connect with investors and showcase its innovative approach.
Read more →MLYSMineralys Therapeutics Reports First Quarter 2023 Financial Results and Provides Corporate Update - Commenced patient dosing in lorundrostat pivotal clinical program, for the treatment of patients with uncontrolled or re
Mineralys Therapeutics reported its first quarter 2023 financial results, highlighting the commencement of patient dosing in the pivotal Advance-HTN trial for lorundrostat. The company plans to initiate further pivotal trials and recently presented positive outcomes from earlier studies. Despite increasing net losses and R&D expenses, Mineralys maintains a solid financial position with sufficient cash reserves to support ongoing clinical studies through mid-2025.
Read more →MLYSMineralys Therapeutics Announces First Patient Dosed in the ADVANCE-HTN Pivotal Trial of Lorundrostat for the Treatment of Uncontrolled and Resistant Hypertension
Mineralys Therapeutics has announced the first patient dosed in its ADVANCE-HTN trial, evaluating lorundrostat for uncontrolled hypertension. This pivotal trial is part of a broader program aimed at addressing the significant unmet need for effective hypertension treatments. Encouraging results are anticipated in the first half of 2024, alongside plans for a Phase 2 trial focusing on chronic kidney disease patients. The company emphasizes the importance of lorundrostat, particularly for patients with obesity, in managing hypertension driven by abnormal aldosterone levels.
Read more →MLYSMineralys Therapeutics to Announce First Quarter 2023 Financial Results and Host Conference Call on Monday, May 15, 2023
Mineralys Therapeutics, Inc. has announced it will report its first quarter financial results for 2023 on May 15, 2023, after market close. Following the report, the company's management will host a conference call to discuss the results. The company is known for its development of drugs targeting diseases associated with elevated aldosterone. Its lead candidate, lorundrostat, is aimed at treating uncontrolled hypertension.
Read more →MLYSMineralys Therapeutics to Participate in the Bank of America Securities 2023 Health Care Conference on Wednesday, May 10, 2023
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, is set to participate in the Bank of America Securities 2023 Health Care Conference on May 10, 2023. The company's CEO, Jon Congleton, and CFO, Adam Levy, will engage in a fireside chat during the event. This highlights Mineralys' focus on developing treatments targeting diseases related to elevated aldosterone levels, particularly their candidate lorundrostat for uncontrolled hypertension. The event indicates the company's ongoing commitment to engaging with investors and the healthcare community.
Read more →MLYSMineralys Therapeutics Reports Fourth Quarter and Full Year 2022 Financial Results and Provides Corporate Update - Lorundrostat pivotal clinical program, for the treatment of patients with uncontrolled hypertension, expe
Mineralys Therapeutics has announced its financial results for Q4 and the full year of 2022 while providing an update on its pivotal clinical program for lorundrostat, aimed at treating uncontrolled hypertension. The company completed its IPO in February 2023, raising approximately $202 million to support its clinical development efforts. Positive results from the Phase 2 Target-HTN trial have led to plans for a pivotal program, scheduled to start in the first half of 2023. Despite a reported net loss of $29.8 million for 2022, the company's financial position strengthened with the IPO proceeds.
Read more →MLYSMineralys Therapeutics Presents Positive Lorundrostat Results from the Phase 2 Target-HTN Trial at ACC.23/WCC
Mineralys Therapeutics announced positive results from the Phase 2 Target-HTN trial for lorundrostat, an aldosterone synthase inhibitor aimed at treating uncontrolled hypertension. The results highlighted a significant placebo-adjusted reduction in systolic blood pressure among obese participants, with improvements seen from both 50mg and 100mg dosing regimens. The company plans to initiate an additional clinical trial in the first half of 2023, underscoring its commitment to advancing lorundrostat's development. This drug may offer a new treatment option as the prevalence of uncontrolled hypertension continues to rise.
Read more →MLYSMineralys Therapeutics to Announce Fourth Quarter 2022 Financial Results and Host Conference Call on Wednesday, March 15, 2023
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, announced that it will report its fourth quarter financial results for 2022 on March 15, 2023. A conference call will follow the release to discuss these results and provide updates on the company's lead product candidate, lorundrostat. The ongoing development of medicines targeting elevated aldosterone reflects the company's commitment to addressing uncontrolled hypertension in patients.
Read more →MLYSMineralys Therapeutics Abstracts Selected to be Presented at the American College of Cardiology Annual Scientific Session & Expo Together with the World Congress of Cardiology (ACC.23/WCC) in March 2023
Mineralys Therapeutics announced that abstracts featuring lorundrostat clinical data will be presented at the ACC.23/WCC in March 2023. The presentations will include a moderated poster and a poster detailing its efficacy in lowering blood pressure in patients with obesity and RAAS dysregulation. Lorundrostat is a selective aldosterone synthase inhibitor, aimed at treating uncontrolled hypertension. Despite some reported adverse effects, the data indicates its potential effectiveness in addressing this condition.
Read more →MLYSMineralys Therapeutics Announces Closing of Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares
Mineralys Therapeutics, Inc. has successfully closed its initial public offering, securing gross proceeds of $220.8 million from the sale of 13.8 million shares, including an additional 1.8 million shares purchased by underwriters. The offering was priced at $16.00 per share and is part of the company’s strategy to advance its focus on developing treatments targeting diseases related to elevated aldosterone levels. The stock is now listed on the Nasdaq under the ticker MLYS.
Read more →MLYSMineralys Therapeutics Announces Pricing of Upsized Initial Public Offering
Mineralys Therapeutics, a clinical-stage biopharmaceutical company, has announced the pricing of its upsized initial public offering, raising $192.0 million. The offering consists of 12 million shares priced at $16.00 each, with trading on the Nasdaq beginning February 10, 2023. The company focuses on developing treatments targeting diseases driven by elevated aldosterone, including its product candidate lorundrostat for uncontrolled hypertension. The offering closes on February 14, 2023, pending customary closing conditions.
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