FDA accepts Mineralys (Nasdaq: MLYS) NDA for lorundrostat, sets Dec 2026 PDUFA
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
Mineralys Therapeutics reported first quarter 2026 results and a major regulatory milestone for its lead drug, lorundrostat. The FDA accepted the New Drug Application for lorundrostat in adults with hypertension in combination with other drugs and set a PDUFA target date of December 22, 2026.
For the quarter ended March 31, 2026, net loss was $39.3 million, slightly improved from $42.2 million a year earlier, as research and development expenses fell to $24.4 million from $37.9 million after completion of the pivotal program. General and administrative expenses increased to $21.0 million from $6.6 million, reflecting higher professional fees and headcount. Cash, cash equivalents and investments totaled $646.1 million, and the company believes this will fund planned activities and operations into 2028.
Positive
- FDA accepted lorundrostat’s NDA and set a December 22, 2026 PDUFA target date, advancing the company’s lead hypertension candidate into formal late-stage regulatory review.
- Cash, cash equivalents and investments of $646.1 million as of March 31, 2026 are expected to fund planned clinical, regulatory and corporate activities into 2028.
Negative
- None.
Insights
FDA NDA acceptance and strong cash runway highlight Mineralys’ Q1 2026 update.
Mineralys Therapeutics secured FDA acceptance of its lorundrostat NDA for hypertension, with a PDUFA target date of December 22, 2026. This moves the program into formal late-stage regulatory review, a key step toward potential commercialization if the data package is deemed sufficient.
Financially, Q1 2026 net loss was $39.3 million versus $42.2 million a year earlier. R&D fell to $24.4 million as pivotal studies concluded, while G&A rose to $21.0 million, reflecting pre-commercial spending. Cash, cash equivalents and investments of $646.1 million are expected to fund operations into 2028, supporting ongoing regulatory work and launch preparation.
Execution now depends on the FDA’s review process through the December 22, 2026 PDUFA date and on continued pre-commercial build-out. Future updates on regulatory interactions and any additional data releases will shape the outlook for lorundrostat’s potential approval and launch trajectory.
8-K Event Classification
2 items: 2.02, 9.01
2 items
Item 2.02
Results of Operations and Financial Condition
Financial
Disclosure of earnings results, typically an earnings press release or preliminary financials.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
PDUFA target date: December 22, 2026
Net loss: $39.3 million
Net loss prior year: $42.2 million
+5 more
8 metrics
PDUFA target date
December 22, 2026
FDA review timeline for lorundrostat NDA
Net loss
$39.3 million
Quarter ended March 31, 2026
Net loss prior year
$42.2 million
Quarter ended March 31, 2025
R&D expenses
$24.4 million
Quarter ended March 31, 2026
R&D expenses prior year
$37.9 million
Quarter ended March 31, 2025
G&A expenses
$21.0 million
Quarter ended March 31, 2026
Cash, cash equivalents and investments
$646.1 million
As of March 31, 2026
Net loss per share
$0.47
Basic and diluted, quarter ended March 31, 2026
Key Terms
New Drug Application (NDA), PDUFA target date, aldosterone synthase inhibitor, uncontrolled or resistant hypertension, +1 more
5 terms
New Drug Application (NDA) regulatory
"Lorundrostat New Drug Application (NDA) – The U.S. Food and Drug Administration (FDA) accepted the NDA"
A new drug application (NDA) is a formal request submitted to regulatory authorities to gain approval for a new medication to be sold and used by the public. It is a comprehensive review process that examines the drug’s safety, effectiveness, and manufacturing quality. For investors, an NDA approval can signal a potential breakthrough product and influence a company's stock value.
PDUFA target date regulatory
"and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026"
A PDUFA target date is the deadline set by the U.S. Food and Drug Administration (FDA) for deciding whether to approve or reject a new medical product. It acts like a firm due date for a decision, which can influence investor expectations and market movements, as approval can lead to product launch and revenue opportunities. This date helps investors anticipate potential news and plan their strategies accordingly.
aldosterone synthase inhibitor medical
"lorundrostat is a proprietary, orally administered, highly selective aldosterone synthase inhibitor"
Aldosterone synthase inhibitors are drugs that reduce production of the hormone aldosterone, which helps control salt, water balance, and blood pressure. Think of them as turning down a faucet that feeds excess blood pressure and fluid buildup; by lowering aldosterone they can ease strain on the heart and kidneys. Investors track these drugs because trial results, regulatory approval, and safety can materially affect a developer’s revenue outlook and stock value.
uncontrolled or resistant hypertension medical
"being developed for the treatment of uncontrolled hypertension (uHTN) or resistant hypertension (rHTN)"
Uncontrolled or resistant hypertension is high blood pressure that does not fall to safe levels despite standard treatment or lifestyle changes; think of it as a leak that won't stop even after several patches. For investors, it signals a sizable unmet medical need and potential market opportunity for new drugs, devices, or care models, while also affecting healthcare costs, regulatory scrutiny and the commercial prospects of therapies targeting hard-to-treat patients.
open-label extension trial medical
"The Company’s ongoing open-label extension trial, which supported the NDA submission"
Earnings Snapshot
Net loss: $39.3 million
Q1 2026
Net loss
$39.3 million
vs $42.2 million in Q1 2025
R&D expenses
$24.4 million
vs $37.9 million in Q1 2025
G&A expenses
$21.0 million
vs $6.6 million in Q1 2025
Cash, cash equivalents and investments
$646.1 million
vs $656.6 million at December 31, 2025
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported): May 6, 2026
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☒
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Item 2.02 Results of Operations and Financial Condition.
On May 6, 2026, Mineralys Therapeutics, Inc. issued a press release announcing its financial results for the quarter ended March 31, 2026 and provided a corporate update. A copy of the press release is attached hereto as Exhibit 99.1 and is incorporated herein by reference.
In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the Exchange Act), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits
| Exhibit No. | Description | |||||||
99.1 | Press Release Issued on May 6, 2026 | |||||||
| 104 | Cover Page Interactive Data File (embedded within the Inline XBRL document) | |||||||
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Dated: May 6, 2026 | MINERALYS THERAPEUTICS, INC. | |||||||
| By: | /s/ Adam Levy | |||||||
| Name: | Adam Levy | |||||||
| Title: | Chief Financial Officer and Secretary | |||||||
Exhibit 99.1
 | ||
Mineralys Therapeutics Reports First Quarter 2026 Financial Results and Provides Corporate Update
– NDA for lorundrostat in adults with hypertension accepted by FDA; assigned PDUFA target date of December 22, 2026 –
– Conference call today at 4:30 p.m. ET –
RADNOR, PA – May 6, 2026 – Mineralys Therapeutics, Inc. (Nasdaq: MLYS), a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other diseases driven by dysregulated aldosterone, today announced financial results for the first quarter ended March 31, 2026, and provided a corporate update.
“We continue to make strong progress advancing lorundrostat toward potential approval, moving closer towards our goal of delivering what we believe has the potential to be a best-in-class aldosterone synthase inhibitor for patients with uncontrolled or resistant hypertension,” said Jon Congleton, Chief Executive Officer of Mineralys Therapeutics. “The FDA’s acceptance of our NDA in the first quarter marks a significant milestone for Mineralys. We continue to advance pre-commercial activities to support a successful launch of lorundrostat while maintaining strategic flexibility.”
Recent Clinical Highlights and Upcoming Milestones
•Lorundrostat New Drug Application (NDA) – The U.S. Food and Drug Administration (FDA) accepted the NDA for lorundrostat for the treatment of hypertension in combination with other antihypertensive drugs and assigned a Prescription Drug User Fee Act (PDUFA) target date of December 22, 2026. The NDA submission included the diverse dataset the Company has built with lorundrostat across five positive clinical trials that demonstrated clinically meaningful blood pressure (BP) reduction, 24-hour control and a favorable safety profile in adults with uncontrolled or resistant hypertension.
•Transform-HTN Open-Label Extension Trial – The Company’s ongoing open-label extension trial, which supported the NDA submission, enables participants to continue to receive lorundrostat and allows the Company to gather additional long-term safety and efficacy data.
•Pre-Commercial Activities Underway – The Company is executing on its pre-commercial activities in preparation for the December 22, 2026 PDUFA target date for lorundrostat. This includes engaging in market access discussions, expanded medical advocacy through communications efforts in the field to support broader education of the unmet need in uncontrolled or resistant hypertension, and sales and marketing activities preparing lorundrostat for a successful launch.
First Quarter 2026 Financial Highlights
Cash, cash equivalents and investments were $646.1 million as of March 31, 2026, compared to $656.6 million as of December 31, 2025. The Company believes that its current cash, cash equivalents and investments will be sufficient to fund its planned clinical trials and regulatory activities, as well as support corporate operations, into 2028.
Research and development (R&D) expenses for the quarter ended March 31, 2026 were $24.4 million, compared to $37.9 million for the quarter ended March 31, 2025. The decrease in R&D expenses was primarily driven by a $15.5 million reduction in preclinical and clinical costs following the conclusion of the lorundrostat pivotal program in the second quarter of 2025. This decrease was partially offset by $1.1 million of increased clinical supply, manufacturing and regulatory costs and $0.8 million of increased personnel-related expenses resulting from headcount growth and increased compensation.
General and administrative (G&A) expenses were $21.0 million for the quarter ended March 31, 2026, compared to $6.6 million for the quarter ended March 31, 2025. The increase in G&A expenses was primarily driven by $7.9 million of higher professional fees, $6.1 million of increased personnel-related expenses resulting from headcount growth and increased compensation and $0.4 million of other general and administrative expenses.
Total other income, net was $6.0 million for the quarter ended March 31, 2026, compared to $2.2 million for the quarter ended March 31, 2025. The increase reflects higher interest earned on investments in money market funds and U.S. Treasuries due to higher average cash balances invested during the quarter ended March 31, 2026.
Net loss was $39.3 million for the quarter ended March 31, 2026, compared to $42.2 million for the quarter ended March 31, 2025. The decrease was primarily attributable to the factors impacting the Company’s expenses described above.
Conference Call
The Company’s management team will host a conference call at 4:30 p.m. ET today, May 6, 2026. To access the call, please dial 1-877-704-4453 in the United States or 1-201-389-0920 outside the United States. A live webcast of the conference call may be found at (click here). A replay of the call will be available on the “News & Events” page in the Investors section of the Mineralys Therapeutics website (click here).
About Hypertension
Having sustained, elevated blood pressure (BP) (or hypertension) increases the risk of heart disease, heart attack and stroke, which are leading causes of death in the United States. In 2022, more than 685,000 deaths in the United States included hypertension as a primary or contributing cause. Hypertension and related health issues resulted in an estimated annual economic burden of about $219 billion in the United States in 2019.
Less than 50% of hypertension patients achieve their BP 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 uncontrolled hypertension (uHTN) or resistant hypertension (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, has an observed half-life of 10-12 hours and demonstrated a 40-70% reduction in plasma aldosterone concentration in hypertensive participants.
The Company has now completed six late-stage clinical trials of lorundrostat supporting its efficacy and safety profile while also validating aldosterone as an integral therapeutic target in uHTN and rHTN. The clinical program includes two pivotal, registrational trials, the Phase 3 Launch-HTN trial and Phase 2 Advance-HTN trial, which support the robust, durable and clinically meaningful reductions in systolic BP by lorundrostat. Lorundrostat was well tolerated in both trials with a favorable safety profile.
About Mineralys
Mineralys Therapeutics is a biopharmaceutical company focused on developing medicines to target hypertension and related comorbidities such as CKD, OSA and other diseases driven by dysregulated aldosterone. Its initial product candidate, lorundrostat, is a proprietary, orally administered, highly selective aldosterone synthase inhibitor. Mineralys is based in Radnor, Pennsylvania, and was founded by Catalys Pacific. For more information, please visit https://mineralystx.com. Follow Mineralys on LinkedIn, Twitter and Bluesky.
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 anticipated timing of the FDA’s review of our accepted NDA and any subsequent regulatory approval of lorundrostat; the planned future clinical development of lorundrostat and the timing thereof; and the sufficiency of our cash, cash equivalents and investments to fund our operations. 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; any delays in the FDA’s review of our accepted NDA, including as a result of a government shutdown or reductions in agency funding or personnel, 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 regulatory approval of lorundrostat; later developments with the FDA may be inconsistent with the feedback from prior meetings, including whether the proposed pivotal
program will support registration of lorundrostat following the FDA’s review of our NDA submission; 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; 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; macroeconomic trends and uncertainty with regard to high interest rates, elevated inflation, tariffs and other trade policies, and the potential for a local and/or global economic recession; our ability to maintain undisrupted business operations due to any pandemic or future public health concerns; regulatory developments in the United States and foreign countries; our reliance on our exclusive license with Tanabe Pharma Corporation 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 Relations
investorrelations@mineralystx.com
Media Relations
Melyssa Weible
Elixir Health Public Relations
Email: mweible@elixirhealthpr.com
Mineralys Therapeutics, Inc.
Condensed Statements of Operations
(in thousands, except share and per share data)
(unaudited)
| Three Months Ended | |||||||||||
| March 31, | |||||||||||
| 2026 | 2025 | ||||||||||
| Operating expenses: | |||||||||||
| Research and development | $ | 24,365 | $ | 37,879 | |||||||
| General and administrative | 20,975 | 6,568 | |||||||||
| Total operating expenses | 45,340 | 44,447 | |||||||||
| Loss from operations | (45,340) | (44,447) | |||||||||
| Interest income, net | 5,996 | 2,239 | |||||||||
| Other income (expense) | 5 | (3) | |||||||||
| Total other income, net | 6,001 | 2,236 | |||||||||
| Net loss | $ | (39,339) | $ | (42,211) | |||||||
| Net loss per share attributable to common stockholders, basic and diluted | $ | (0.47) | $ | (0.79) | |||||||
| Weighted-average shares used in computing net loss per share attributable to common stockholders, basic and diluted | 82,834,752 | 53,163,551 | |||||||||
Mineralys Therapeutics, Inc.
Selected Financial Information
Condensed Balance Sheet Data
(amounts in thousands)
(unaudited)
| March 31, | December 31, | ||||||||||
| 2026 | 2025 | ||||||||||
| Cash, cash equivalents and investments | $ | 646,060 | $ | 656,635 | |||||||
| Total assets | $ | 652,862 | $ | 661,806 | |||||||
| Total liabilities | $ | 14,718 | $ | 15,113 | |||||||
| Total stockholders’ equity | $ | 638,144 | $ | 646,693 | |||||||
FAQ
What did Mineralys Therapeutics (MLYS) announce about lorundrostat in this update?
Mineralys reported that the FDA accepted its New Drug Application for lorundrostat to treat hypertension in combination with other drugs. The agency set a PDUFA target decision date of December 22, 2026, moving the program into formal late-stage regulatory review.
How much cash does Mineralys Therapeutics (MLYS) have and how long will it last?
Mineralys held $646.1 million in cash, cash equivalents and investments as of March 31, 2026, down slightly from $656.6 million at December 31, 2025. The company believes this balance will fund planned clinical, regulatory and corporate operations into 2028, including pre-commercial activities.
How did Mineralys’ research and development and G&A expenses change year over year?
Research and development expenses fell to $24.4 million in Q1 2026 from $37.9 million in Q1 2025, mainly due to lower preclinical and clinical costs after the pivotal lorundrostat program concluded. General and administrative expenses rose to $21.0 million from $6.6 million, driven by higher professional fees and personnel costs.
What clinical data support Mineralys’ NDA for lorundrostat?
The lorundrostat NDA includes a dataset from five positive clinical trials showing clinically meaningful blood pressure reductions, 24‑hour control and a favorable safety profile in adults with uncontrolled or resistant hypertension. It is also supported by an ongoing Transform‑HTN open‑label extension trial collecting long‑term safety and efficacy data.
What is lorundrostat and what conditions is Mineralys targeting?
Lorundrostat is an orally administered, highly selective aldosterone synthase inhibitor designed to lower aldosterone by inhibiting CYP11B2. Mineralys is developing it for uncontrolled or resistant hypertension and related comorbidities such as chronic kidney disease and obstructive sleep apnea, where dysregulated aldosterone plays a key role.