Welcome to our dedicated page for Mineralys Therapeutics SEC filings (Ticker: MLYS), a comprehensive resource for investors and traders seeking official regulatory documents including 10-K annual reports, 10-Q quarterly earnings, 8-K material events, and insider trading forms.
The Mineralys Therapeutics, Inc. (Nasdaq: MLYS) SEC filings page on Stock Titan provides access to the company’s regulatory disclosures as it advances lorundrostat, a proprietary, orally administered, highly selective aldosterone synthase inhibitor, through clinical development. As a clinical-stage biopharmaceutical company focused on hypertension, chronic kidney disease (CKD), obstructive sleep apnea (OSA) and other aldosterone-driven diseases, Mineralys uses SEC filings to report financial results, capital-raising activities and other material events.
Current and prospective investors can review Form 8-K filings where Mineralys reports quarterly financial results and corporate updates, as well as transactions such as underwritten public offerings of common stock and changes to at-the-market equity programs. These documents often reference the company’s clinical progress with lorundrostat, including pivotal trials like Launch-HTN and Advance-HTN, Phase 2 programs such as Explore-CKD and Explore-OSA, and steps toward a potential New Drug Application (NDA) with the U.S. Food and Drug Administration.
Over time, the filings set is expected to include annual reports on Form 10-K, quarterly reports on Form 10-Q, and additional 8-Ks that elaborate on risk factors, liquidity, research and development spending, and the company’s dependence on the success of lorundrostat and key licensing arrangements. Investors may also monitor registration statements and prospectus supplements related to equity offerings, as reflected in referenced Form S-3 filings.
Stock Titan enhances these SEC documents with AI-powered summaries that highlight key points, such as trial-related disclosures, financing terms and forward-looking statements. Real-time updates from EDGAR, combined with tools to track items like material events and offering details, help users quickly understand how Mineralys Therapeutics’ regulatory and financial reporting aligns with its clinical and regulatory strategy for lorundrostat.
Mineralys Therapeutics Chief Medical Officer Rodman David Malcom reported option exercises and share sales in Mineralys Therapeutics, Inc. common stock. On March 12–13, 2026, he exercised stock options for a total of 14,057 shares of common stock at exercise prices of $1.08, $10.20, and $14.25 per share. He then sold 20,406 shares in open-market transactions at weighted-average prices between approximately $25.77 and $27.92, executed under a pre-arranged Rule 10b5-1 trading plan adopted on October 6, 2025. Following these transactions, he directly holds 76,140 shares of Mineralys Therapeutics common stock.
Mineralys Therapeutics reports multiple sales of Common Stock by David Rodman. The filings list a series of dispositions between 01/02/2026 and 03/12/2026, including transfers of 192,715 shares on 01/05/2026 and smaller tranches through March.
Transactions are characterized as cash or broker‑assisted cashless exercises and list per‑trade share counts and proceeds, indicating routine insider dispositions over the stated period.
Mineralys Therapeutics outlines its strategy to develop lorundrostat, an oral, highly selective aldosterone synthase inhibitor aimed at treating hypertension and related cardiorenal conditions such as CKD and OSA. The company has completed multiple Phase 2 and Phase 3 trials showing clinically meaningful blood pressure reductions and generally favorable safety.
In December 2025, Mineralys submitted a new drug application for lorundrostat for hypertension in combination with other antihypertensive drugs, which the FDA accepted with a PDUFA target action date of December 22, 2026. The report highlights strong Launch-HTN and Advance-HTN pivotal results, positive Explore-CKD data, mixed but BP‑positive Explore-OSA findings, substantial patent and licensing protections, and emphasizes that future performance and revenue depend heavily on successfully obtaining approval and commercializing lorundrostat while securing additional funding.
Mineralys Therapeutics (MLYS) reported insider dispositions. David Rodman reported multiple sales of Common Stock over January–March 2026, including a broker-assisted cashless exercise reported on 03/12/2026 covering 6,348 shares. The filing lists several prior dispositions in the three months before that date with individual sale dates and share counts.
Mineralys Therapeutics reported fourth quarter and full-year 2025 results and highlighted major regulatory progress for its lead drug lorundrostat. The FDA accepted the company’s New Drug Application for lorundrostat in adults with hypertension in combination with other drugs, assigning a PDUFA target decision date of December 22, 2026.
Cash, cash equivalents and investments rose to $656.6 million as of December 31, 2025, from $198.2 million a year earlier, which the company expects to fund operations into 2028. For 2025, research and development expenses fell to $132.0 million and net loss narrowed to $154.7 million, reflecting completion of pivotal lorundrostat trials and higher interest income.
Mineralys Therapeutics Chief Medical Officer David Malcom Rodman exercised stock options for 2,171 shares of common stock at $16.00 per share and on the same day sold 2,171 shares at $26.84 per share in an open-market transaction. The filing describes these moves as an exercise or conversion of derivative securities followed by a sale. After the transactions, he directly owned 82,489 shares of common stock and held stock options covering 23,876 shares. The company notes that these transactions were carried out under a pre-arranged Rule 10b5-1 trading plan adopted on October 6, 2025, indicating they were scheduled in advance.
Mineralys Therapeutics insider transactions: David Rodman reported multiple sales of common stock, including a sale of 192,715 shares on 01/05/2026 for $6,749,100.06. The filing also shows numerous smaller open‑market sales in January–February 2026 and a broker‑assisted cashless exercise of 2,171 shares on 03/09/2026.
Mineralys Therapeutics reports that the U.S. FDA has accepted its New Drug Application (NDA) for lorundrostat to treat adult patients with hypertension in combination with other antihypertensive drugs. The FDA set a Prescription Drug User Fee Act (PDUFA) target action date of December 22, 2026.
Topline data from the Phase 2 Explore-OSA exploratory trial in 48 overweight or obese adults with moderate-to-severe obstructive sleep apnea (OSA) and hypertension showed lorundrostat 50 mg did not improve apnea-hypopnea index (AHI), the primary endpoint, versus placebo after four weeks. However, lorundrostat produced an 11.1 mmHg systolic blood pressure reduction versus 1.0 mmHg with placebo and a 6.2 mmHg placebo-adjusted reduction in crossover analysis, with a favorable safety profile and no serum potassium above 5.5 mmol/L.
Mineralys Therapeutics, Inc. filed an initial ownership report for Chief Commercial Officer Warren Eric. It shows direct holdings of stock options covering 357,000 shares and another 51,300-share option, plus 38,400 shares of common stock. Footnotes describe restricted stock units granted for no cash consideration that vest over four years starting on February 19, 2026. One option grant vests 25% on the first anniversary of April 21, 2025, with the rest vesting in 36 monthly installments, while another vests in 48 equal monthly installments beginning after February 19, 2026.
RA CAPITAL MANAGEMENT, L.P. reported acquisition or exercise transactions in this Form 4 filing.
Mineralys Therapeutics, Inc. reported an insider equity award arrangement involving RA Capital–affiliated entities. A partner of RA Capital Management serving on Mineralys’ board received 6,200 restricted stock units and a stock option for 8,300 shares of common stock, both granted for no additional cash consideration.
The RSUs vest in one annual installment after the grant date, while the option vests in 12 substantially equal monthly installments. According to the disclosures, these awards are held for the benefit of RA Capital Healthcare Fund and RA Capital Nexus Fund III, with any shares or cash received offsetting advisory fees owed to RA Capital Management. The reporting persons disclaim beneficial ownership of the option and underlying common stock except to the extent of their pecuniary interest. Indirect holdings also include 5,456,521 shares of common stock held directly by the fund and 1,867,229 shares held directly by Nexus Fund III.