Mineralys Therapeutics Announces Publication of Pivotal Phase 2 Advance-HTN Results in the New England Journal of Medicine (NEJM)
– Detailed results from the second pivotal Phase 3 Launch-HTN trial to be presented at an upcoming medical conference and published in a peer-reviewed publication –
RADNOR, Pa., April 23, 2025 (GLOBE NEWSWIRE) -- Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced that the New England Journal of Medicine (NEJM) published the detailed results from the Company's pivotal Phase 2 Advance-HTN trial, the first of two pivotal trials evaluating lorundrostat in patients with uncontrolled hypertension (uHTN) or resistant hypertension (rHTN). The full manuscript is titled, 'Lorundrostat Efficacy and Safety in Patients with Uncontrolled Hypertension,' and is featured in the April 23, 2025 issue of NEJM.
The key data from the publication showed that lorundrostat 50 mg demonstrated a 15.4 mmHg absolute reduction and a 7.9 mmHg placebo-adjusted reduction (p=0.001), in 24-hour ambulatory blood pressure at week 12. Lorundrostat worked equally well in those taking two baseline medications and those taking three or more, and in both men and women as well as in white and black patients. Lorundrostat demonstrated a favorable safety and tolerability profile, with modest changes in potassium, sodium and eGFR.
'The publication of our Advance-HTN trial results in the New England Journal of Medicine is a significant milestone that underscores both the strength of our clinical data and the potentially transformative nature of this new class of medicines that could help address dysregulated aldosterone, an unaddressed, key driver of hypertension,' stated Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. 'Prior studies have shown that even modest reductions in systolic blood pressure can lead to a substantial decrease in the incidence of major cardiovascular events. The blood pressure reductions with lorundrostat observed in the Advance-HTN trial are particularly meaningful given the well-established correlation between elevated blood pressure, dysregulated aldosterone production and cardiovascular risk.'
'The significant blood pressure lowering with lorundrostat 50 mg in the Advance-HTN trial was seen in patients treated by specialists who were taking an optimized standardized antihypertensive regimen – those patients with true uncontrolled or resistant hypertension that desperately need new options to lower their blood pressure,' stated Luke Laffin, M.D., co-director of the Center for Blood Pressure Disorders in the Heart, Vascular & Thoracic Institute at Cleveland Clinic and the study's lead author. 'Currently available therapies to treat hypertension do not decrease aldosterone production in the body, and we know aldosterone dysregulation is a driving factor in the blood pressure elevation of many of our patients. The findings reinforce the critical role of aldosterone in the pathogenesis of hypertension and the potential of lorundrostat to address unmet medical needs facing patients with uncontrolled or treatment-resistant disease.'
The NEJM publication of the detailed Advance-HTN results follows a late-breaking presentation of the data at the American College of Cardiology's Annual Scientific Session & Expo (ACC.25) in Chicago on March 29, 2025, and the announcement of positive topline results from both Advance-HTN and Launch-HTN earlier in March.
Mineralys plans to provide additional data from the pivotal Phase 3 Launch-HTN at an upcoming medical conference and in a peer-reviewed publication. Additionally, the ongoing Transform-HTN open-label extension trial allows subjects to continue to receive lorundrostat and obtain additional safety and efficacy data.
About Hypertension
Having sustained, elevated blood pressure (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the U.S. In 2020, more than 670,000 deaths in the U.S. included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an average annual economic burden of about $219 billion in the U.S. in 2019.
Less than 50% of hypertension patients achieve their blood pressure goal with currently available medications. Dysregulated aldosterone levels are a key factor in driving hypertension in approximately 30% of all hypertensive patients.
About Lorundrostat
Lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor being developed for the treatment of uHTN or rHTN, as well as CKD and OSA. Lorundrostat was designed to reduce aldosterone levels by inhibiting CYP11B2, the enzyme responsible for its production. Lorundrostat has 374-fold selectivity for aldosterone-synthase inhibition versus cortisol-synthase inhibition in vitro, an observed half-life of 10-12 hours and demonstrated approximately a 70% reduction in plasma aldosterone concentration in hypertensive subjects.
In a Phase 2, proof-of-concept trial (Target-HTN) in uncontrolled or resistant hypertensive subjects, once-daily lorundrostat demonstrated statistically significant and clinically meaningful blood pressure reduction in both automated office blood pressure measurement and 24-hour ambulatory blood pressure monitoring. Adverse events observed were a modest increase in serum potassium, decrease in estimated glomerular filtration rate, urinary tract infection and hypertension with one serious adverse event possibly related to study drug being hyponatremia.
About Advance-HTN
The Advance-HTN trial (NCT05769608) was a randomized, double-blind, placebo-controlled Phase 2 clinical trial that evaluated the efficacy and safety of lorundrostat for the treatment of uHTN or rHTN, when used as an add-on therapy to a standardized background treatment of two or three antihypertensive medications in adult subjects. Subjects who met screening criteria had their existing hypertension medications discontinued and started on a standard regimen of an angiotensin II receptor blocker (ARB) and a diuretic, if previously on two medications, or a standard regimen of ARB, diuretic and calcium channel blocker if previously on three to five medications. Subjects who remained hypertensive despite the standardized regimen were then randomized into three cohorts and treated for twelve weeks: lorundrostat 50 mg once-daily (QD), lorundrostat 50 mg QD and an option to titrate to 100 mg QD at week four based on defined criteria, or placebo. The trial's primary endpoint was the change in 24-hour ambulatory systolic blood pressure at week twelve from baseline for active cohorts versus placebo.
About Mineralys
Mineralys Therapeutics is a clinical-stage biopharmaceutical company focused on developing medicines to target hypertension, CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor that Mineralys Therapeutics is developing for the treatment of cardiorenal conditions affected by dysregulated aldosterone, including hypertension, CKD and OSA. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn and Twitter.
Forward Looking Statements
Mineralys Therapeutics cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. The forward-looking statements are based on our current beliefs and expectations and include, but are not limited to, statements regarding: the potential therapeutic benefits of lorundrostat; the Company's expectation that Advance-HTN and Launch-HTN may serve as pivotal trials in any submission of a new drug application (NDA) to the United States Food and Drug Administration (FDA); the Company's ability to evaluate lorundrostat as a potential treatment for CKD, OSA, uHTN or rHTN; and the planned future clinical development of lorundrostat and the timing thereof. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in our business, including, without limitation: topline results that we report are based on a preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the clinical trial and such topline data may not accurately reflect the complete results of a clinical trial; our future performance is dependent entirely on the success of lorundrostat; potential delays in the commencement, enrollment and completion of clinical trials and nonclinical studies; later developments with the FDA may be inconsistent with the feedback from the completed end of Phase 2 meeting, including whether the proposed pivotal program will support registration of lorundrostat which is a review issue with the FDA upon submission of an NDA; the results of our clinical trials, including the Advance-HTN and Launch-HTN trials, may not be deemed sufficient by the FDA to serve as the basis for an NDA submission or regulatory approval of lorundrostat; our dependence on third parties in connection with manufacturing, research and clinical and nonclinical testing; unexpected adverse side effects or inadequate efficacy of lorundrostat that may limit its development, regulatory approval and/or commercialization; unfavorable results from clinical trials and nonclinical studies; results of prior clinical trials and studies of lorundrostat are not necessarily predictive of future results; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Mitsubishi Tanabe Pharma to provide us with intellectual property rights to develop and commercialize lorundrostat; and other risks described in our filings with the Securities and Exchange Commission (SEC), including under the heading 'Risk Factors' in our annual report on Form 10-K, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Contact:Investor Relationsinvestorrelations@mineralystx.com
Media RelationsTom WeibleElixir Health Public RelationsPhone: (1) 515-707-9678Email: tweible@elixirhealthpr.comSign in to access your portfolio
Hashtags
Try Our AI Features
Explore what Daily8 AI can do for you:
Comments
No comments yet...
Related Articles
Yahoo
18 minutes ago
- Yahoo
AI drives new highs
By Jamie McGeever ORLANDO, Florida (Reuters) -TRADING DAY Making sense of the forces driving global markets By Jamie McGeever, Markets Columnist Key U.S. and global stock markets clocked fresh highs on Thursday as Alphabet's earnings lifted tech, while investors digested the European Central Bank's interest rate decision and the latest signals from the European Union on trade talks with the U.S. More on that below. In my column today I ask if the stock market euphoria around the incoming U.S. trade deals is warranted. Remember, tariffs will be the highest since the 1930s and are set to raise inflation and lower growth. If you have more time to read, here are a few articles I recommend to help you make sense of what happened in markets today. 1. ECB keeps rates steady as it awaits clarity over trade 2. Big central bank rate cuts slow with tariffs andpolitics in headlights 3. Conditions as loose as 2021 call into question more Fedcuts: Mike Dolan 4. Meme stock surge underlines market froth, mostlycentered on retail investors 5. In earnings season, it's AI good, everything else, notso much Today's Key Market Moves * S&P 500, Nasdaq, FTSE 100 and MSCI All Country all hit newhighs again. * But the Dow and Russell 2000, less tethered to the AIfrenzy, fall 0.7% and 1.4%, respectively. * Some big U.S. names post big share price declines on Q2earnings: Tesla -9%, IBM -8%, Honeywell -5%. * Oil snaps a four-day losing streak to rise over 1%. * China's yuan hits its strongest level this year againstthe U.S. dollar, both onshore and offshore. AI drives new highs In the absence of major economic data surprises, monetary policy changes or trade deal news on Thursday, world markets took their cue from corporate earnings, which continue to point to strength in artificial intelligence-related activity. Google's parent company Alphabet grabbed the spotlight, its second-quarter results highlighting that the heavy investment in AI is paying off. Indeed, a trend may be emerging from the earnings season that shows businesses focused on AI are massively outperforming companies like airlines, restaurants and food manufacturers that cater more to actual people. This isn't just a U.S. thing, it's global. Of course, this isn't a blanket rule but it will be worth keeping an eye on as the earnings season progresses. So far at least, investors are accentuating the positive and major indices are making new highs on a near daily basis. On the policy front, the ECB kept its deposit rate on hold at 2.0% as expected, biding its time while Brussels and Washington try to negotiate a trade deal that could ease tariff uncertainty. It appears that the bar to resume the easing cycle in September is a high one, and the euro closed the day little-changed around $1.1765. The U.S. economic data on Thursday were relatively upbeat, showing an acceleration in service sector activity and the lowest jobless claims figures in three months. With numbers like that, the S&P 500 at a record high and wider financial conditions loose, the Fed may not be in such a hurry to cut rates. And on that score, investors will be paying close attention to the readout from U.S. President Donald Trump's visit to the Fed late on Thursday. Fed Chair Jerome Powell is expected to be present during the visit. It will be an awkward meeting - Trump has repeatedly demanded that the Fed slash interest rates and has frequently raised the possibility of firing him. On Tuesday, he called Powell a "numbskull." Markets' trade deal euphoria ignores tariff reality The optimism sweeping world stock markets following news of emerging and expected U.S. trade deals is undeniable and understandable. But it is also puzzling. The S&P 500, Britain's FTSE 100 and the MSCI All Country index have powered to new highs this week, and other global benchmarks are not far behind. Analysts at Goldman Sachs and other big banks have recently been raising their year-end S&P 500 forecasts by as much as 10%. The catalyst is clear: baseline tariffs on imported goods into the U.S. will be much lower than the duties President Donald Trump had threatened previously. It emerged this week that the levy on Japanese goods will be 15%, not 25%, and indications are that a deal with the European Union will land on 15% too. That's half the rate Trump had threatened to impose. Suddenly, the picture is nowhere near as bleak as it looked a few months ago. Economists reckon that the final aggregate U.S. tariff rate will settle around 15-20% once deals with Brussels and Beijing are reached, a level markets are betting won't tip the economy into recession. This suggests that Trump's seemingly chaotic strategy – threaten mutually assured economic destruction, extract concessions and then pull back to limit the market damage – is paying off. But will it? SOMEONE MUST PAY Despite the market euphoria, the fact remains that on December 31 last year, the average aggregate U.S. tariff on imported goods was around 2.5%. So even if that ends up in the anticipated 15-20% range, it will still be at least six times what it was only a few months ago, and comfortably the highest it has been since the 1930s. U.S. Treasury Secretary Scott Bessent estimates that tariff revenues this year could reach $300 billion, which is the equivalent to around 1% of GDP. Extrapolating last year's goods imports of $3.3 trillion to next year, a 15% levy could raise close to $500 billion, or just over 1.5% of GDP. So who will pick up that tab? Is it the U.S. consumer, importers or the overseas exporters? Or a mixture of all three? The likelihood is it will mostly be split between U.S. consumers and companies, squeezing household spending and corporate profits. Either way, it's hard to see how this would not be detrimental to growth. We may not know for some time, as it will take months for the affected goods to come onshore and get onto U.S. shelves and for the tariff revenues to be collected. "We've got a ways to go before we can really say the U.S. economy is feeling the full effect of the tariff policies being announced," Bob Elliott, a former Bridgewater executive and founder of Unlimited, told CNBC on Wednesday. But in the meantime, equity investors appear to be ignoring all of this. SIGNS OF FROTH The market's short-term momentum is clear. The S&P 500 has closed above its 200-day moving average for 62 days in a row, the longest streak since 1997, according to Carson Group's Ryan Detrick. And the 'meme stock' craze is back too, another sign that risk appetite may be decoupling from fundamentals. Indeed, markets are priced for something approaching perfection. The consensus S&P 500 earnings growth for next year is 14%, according to LSEG I/B/E/S, barely changed from 14.5% on April 1, just before Trump's "Liberation Day" tariff salvo. Even the 2025 consensus of around 9% isn't that much lower than 10.5% on April 1. A Reuters poll late last year showed a 2025 year-end consensus estimate for the S&P 500 of 6,500. The index is nearly there already, and is trading at roughly the same multiple as it was on December 31, a 12-month forward price-to-earnings ratio of 22. Can these lofty expectations be supported by an economy whose growth rate next year is expected to be 2% or less? Possibly. But it will be a challenge for most firms, with the exception of the 'Magnificent Seven' tech giants whose size might better shield them from tariffs or slowing growth. Ultimately, this is all a huge experiment pitting protectionist trade policy and Depression-era tariffs against the economic orthodoxy of the past 40 years. And it's yet another example of equity investors' ability to find the silver lining in almost anything. As Brian Jacobsen, chief economist at Annex Wealth Management, says: "'It could have been worse' is not a good foundation for a market rally". What could move markets tomorrow? * Japan Tokyo CPI inflation (July) * Japan services PPI inflation (June) * UK GfK consumer confidence (July) * UK retail sales (June) * Germany Ifo business sentiment index (July) * U.S. durable goods (June) * U.S. Q2 earnings Want to receive Trading Day in your inbox every weekday morning? Sign up for my newsletter here. Opinions expressed are those of the author. They do not reflect the views of Reuters News, which, under the Trust Principles, is committed to integrity, independence, and freedom from bias. (By Jamie McGeever; Editing by Nia Williams) Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
18 minutes ago
- Yahoo
VeriSign (NASDAQ:VRSN) Reports Q2 In Line With Expectations
Domain name registry operator Verisign (NASDAQ:VRSN) met Wall Street's revenue expectations in Q2 CY2025, with sales up 5.9% year on year to $409.9 million. Its GAAP profit of $2.21 per share was 1.4% above analysts' consensus estimates. Is now the time to buy VeriSign? Find out in our full research report. VeriSign (VRSN) Q2 CY2025 Highlights: Revenue: $409.9 million vs analyst estimates of $411 million (5.9% year-on-year growth, in line) EPS (GAAP): $2.21 vs analyst estimates of $2.18 (1.4% beat) Operating Margin: 68.5%, in line with the same quarter last year Free Cash Flow Margin: 47.5%, down from 71% in the previous quarter Market Capitalization: $27.17 billion Company Overview While the company is not a domain registrar and does not directly sell domain names to end users, Verisign (NASDAQ:VRSN) operates and maintains the infrastructure to support domain names such as .com and .net. Revenue Growth Examining a company's long-term performance can provide clues about its quality. Even a bad business can shine for one or two quarters, but a top-tier one grows for years. Over the last three years, VeriSign grew its sales at a weak 5.2% compounded annual growth rate. This wasn't a great result compared to the rest of the software sector, but there are still things to like about VeriSign. This quarter, VeriSign grew its revenue by 5.9% year on year, and its $409.9 million of revenue was in line with Wall Street's estimates. Looking ahead, sell-side analysts expect revenue to grow 4% over the next 12 months, similar to its three-year rate. This projection is underwhelming and implies its products and services will see some demand headwinds. At least the company is tracking well in other measures of financial health. Today's young investors likely haven't read the timeless lessons in Gorilla Game: Picking Winners In High Technology because it was written more than 20 years ago when Microsoft and Apple were first establishing their supremacy. But if we apply the same principles, then enterprise software stocks leveraging their own generative AI capabilities may well be the Gorillas of the future. So, in that spirit, we are excited to present our Special Free Report on a profitable, fast-growing enterprise software stock that is already riding the automation wave and looking to catch the generative AI next. Customer Acquisition Efficiency The customer acquisition cost (CAC) payback period measures the months a company needs to recoup the money spent on acquiring a new customer. This metric helps assess how quickly a business can break even on its sales and marketing investments. VeriSign is very efficient at acquiring new customers, and its CAC payback period checked in at 25 months this quarter. The company's rapid recovery of its customer acquisition costs means it can attempt to spur growth by increasing its sales and marketing investments. Key Takeaways from VeriSign's Q2 Results Revenue was in line and EPS exceeded expectations by a small amount. Overall, this quarter didn't have too many surprises. The stock remained flat at $285 immediately after reporting. VeriSign underperformed this quarter, but does that create an opportunity to invest right now? The latest quarter does matter, but not nearly as much as longer-term fundamentals and valuation, when deciding if the stock is a buy. We cover that in our actionable full research report which you can read here, it's free. Sign in to access your portfolio
Yahoo
18 minutes ago
- Yahoo
Volcon Rebrands to Empery Digital, Launches $500M Bitcoin Treasury Strategy
By Daniella Parra Volcon (NASDAQ: VLCN) said it closed a $500 million private placement and will allocate over 95% of the proceeds to Bitcoin purchases. The company, which already holds 280.14 BTC, is rebranding as Empery Digital, Inc. with a new ticker symbol 'EMPD' and its powersports division will become Empery Mobility, they said. 'I look forward to fulfilling our promises to investors by operating a low cost, capital efficient, globally trusted bitcoin treasury strategy that will stand the test of time,' said Ryan Lane, co-founder and Principal of Empery Asset Management. 'The formation of this team reflects our strong conviction in Bitcoin as the digital store of value for the future and expresses our belief in the blockchain as a trusted network for many future applications.' READ MORE GameSquare Unveils $100M Ethereum Strategy, Raises $8M in Public Offering Never Miss Our Best Content Contact: Exec Edge Editor@ Click to follow us on LinkedIn Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
