Every 8-K that Mineralys Therapeutics, Inc. (MLYS) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow MLYS and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full MLYS filings page.
Mineralys Therapeutics, Inc. reported second-quarter 2026 results and corporate updates centered on its lead candidate lorundrostat. The FDA is reviewing the New Drug Application for lorundrostat for hypertension with a PDUFA target date of December 22, 2026, and commercial launch preparations are described as on track.
The company strengthened lorundrostat economics by eliminating its royalty obligations to Tanabe through a $200.0 million upfront cash payment and up to $100.0 million in new commercial milestones, leaving total remaining potential Tanabe milestones of up to $255.0 million plus up to $10.0 million for a second indication. Mineralys also completed a follow-on offering of 5,660,378 shares for approximately $150.0 million in gross proceeds and entered a senior secured term loan facility of up to $500.0 million, drawing an initial $100.0 million tranche.
Cash, cash equivalents and investments were $661.4 million as of June 30, 2026, and the company expects this to fund operations, including a potential lorundrostat launch, into 2028. Second-quarter 2026 net loss widened to $241.1 million, driven mainly by the Tanabe upfront payment, with higher R&D and G&A expenses as Mineralys scales toward commercialization. The Board appointed James J. “Terry” Ferguson III, M.D., as Chief Medical Officer, while former CMO David Rodman, M.D., transitions to a full-time Strategic Advisor role.
Mineralys Therapeutics, Inc. entered into an underwriting agreement for a primary offering of 5,660,378 shares of common stock at $26.50 per share. Underwriters will purchase the shares at $25.3075 per share, and net proceeds to Mineralys are expected to be about $142.5 million after fees and expenses.
The offering is expected to close on or about June 4, 2026, subject to customary conditions, and is being conducted under an effective shelf registration statement and prospectus supplement. In its press release, Mineralys stated it intends to use the net proceeds to help fund a $200.0 million upfront payment to repurchase a royalty obligation under its license agreement with Tanabe Pharma Corporation, alongside a previously announced $500 million committed debt facility from funds managed by Pharmakon Advisors.
Mineralys Therapeutics amended its license with Tanabe Pharma to eliminate future royalties on lorundrostat and reshape its payment obligations. The amendment grants Mineralys an exclusive, worldwide, royalty-free, sublicensable, perpetual license and removes diligence requirements for development and commercialization.
Mineralys will pay Tanabe a one-time $200.0 million cash payment and potential commercial milestone payments of up to $255.0 million, plus up to $10.0 million for a second indication. The company also entered a senior secured term loan facility of up to $500.0 million, with a $100.0 million Tranche A drawn at closing and additional tranches contingent on FDA approval of the lorundrostat NDA and specified net sales milestones.
Mineralys Therapeutics, Inc. held its 2026 annual stockholder meeting on May 21, 2026, where two proposals were voted on. Stockholders elected three Class III directors to three-year terms ending at the 2029 annual meeting and ratified Ernst & Young LLP as independent registered public accounting firm for the fiscal year ending December 31, 2026. Both proposals received the requisite affirmative vote of the company’s common stockholders.
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.
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 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 8‑K stating it issued a press release announcing financial results for the quarter ended September 30, 2025 and provided a corporate update. The press release is furnished as Exhibit 99.1.
Consistent with Item 2.02 treatment and General Instruction B.2, the information, including Exhibit 99.1, is furnished and not deemed filed or subject to Section 18 liabilities, and is not incorporated by reference except as specifically set forth.
Mineralys Therapeutics entered into an underwriting agreement to sell 9,803,921 shares of common stock at a public offering price of $25.50 per share, with the underwriters purchasing the shares from the company at $23.97 per share. The company expects net proceeds of approximately $234.7 million, or about $269.9 million if the underwriters' 30-day option to buy an additional 1,470,588 shares is exercised in full. The offering is expected to close on September 4, 2025, subject to customary closing conditions.
The transaction is being conducted under previously declared Form S-3 registration statements and is accompanied by customary representations, indemnities and closing conditions. The filing includes the underwriting agreement and counsel opinion as exhibits. The company also included a forward-looking statements caution noting that actual results may differ due to market conditions and closing risks.
Mineralys Therapeutics, Inc. reported that on September 2, 2025 it delivered written notice to BofA Securities and Evercore Group suspending its use of, and terminating, the April 11, 2024 prospectus supplement for its at-the-market (ATM) equity offering program. This prospectus supplement had covered sales of common stock under the ATM Equity Offering Sales Agreement dated March 21, 2024.
The company stated it will not make any sales of common stock under the Sales Agreement unless and until a new prospectus supplement is filed with the SEC. The underlying Sales Agreement with BofA Securities and Evercore remains in full force and effect.
Mineralys Therapeutics, Inc. furnished a press release announcing its financial results for the quarter ended June 30, 2025 and provided a corporate update; the press release is attached to this Form 8-K as Exhibit 99.1. The Form 8-K states the exhibit is furnished and therefore not deemed "filed" for purposes of Section 18 of the Exchange Act and is not incorporated by reference in other filings except as expressly noted.
The filing confirms the company’s common stock trades under MLYS on Nasdaq and indicates the registrant qualifies as an emerging growth company. No financial tables or numerical results are included in the 8-K text itself; readers must consult Exhibit 99.1 for the full financial details and corporate update.