Highest-materiality recent filing
Mineralys Q2 net loss $241M; lorundrostat PDUFA Dec 22, 2026; new CMO appointed
Q2 2026 net loss $241.1M vs $43.3M in Q2 2025; R&D $221.4M incl $200M Tanabe upfront payment.
Mineralys prices $150M common stock offering at $26.50/sh; proceeds to fund royalty repurchase
5,660,378 shares at $26.50/share; gross proceeds ~$150M, net ~$142.5M.
Mineralys terminates lorundrostat royalties, secures up to $500M debt facility
Amended Tanabe license: $200M one-time payment; royalties eliminated; license perpetual; up to $365M in milestones remain.
Mineralys Therapeutics Q1 net loss $39.3M; FDA accepts lorundrostat NDA with Dec 22, 2026 PDUFA
Net loss $39.3M for Q1 2026 vs $42.2M Q1 2025; cash $646.1M, sufficient into 2028.
Mineralys Therapeutics reports Q4/FY2025 results; FDA accepts lorundrostat NDA, PDUFA Dec 22, 2026
FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.
FDA accepts Mineralys' NDA for hypertension drug lorundrostat; PDUFA Dec 22, 2026
FDA accepted NDA for lorundrostat for hypertension in combination with other antihypertensives; PDUFA target date December 22, 2026.
Mineralys files NDA for lorundrostat, expects Explore-OSA data Q1 2026
Filed new drug application for lorundrostat with FDA in late 2025.
Mineralys Therapeutics Q3 net loss $36.9M; NDA planned late-2025/Q1 2026; cash $593.6M
Net loss $36.9M for Q3 2025 vs $56.3M YoY; R&D expenses fell to $31.5M from $54.0M.
Mineralys prices upsized $250M public offering at $25.50/share
9,803,921 shares at $25.50/share; total gross proceeds ~$250M.
Mineralys Therapeutics Q2 net loss $43.3M; cash $324.9M; pre-NDA meeting set for Q4 2025
Net loss $43.3M vs $41.0M in Q2 2024; R&D expenses $38.3M, G&A $8.5M.
Positive Phase 2 Explore-CKD results for lorundrostat; primary endpoint met
Lorundrostat 25 mg reduced systolic BP by 9.3 mmHg (–7.5 mmHg placebo-adjusted, p=0.0024) in hypertensive CKD patients.
Mineralys reports positive pivotal trial results; Q1 net loss $42.2M; cash $343M
Launch-HTN: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction at week 6 (p<0.0001).
Lorundrostat 50 mg achieved a 7.9 mmHg placebo-adjusted reduction in 24-hour SBP at week 12 (p=0.001).
Mineralys prices $175M public offering (12.96M shares at $13.50); net proceeds ~$164.2M
Offering of 12,962,962 shares at $13.50; gross proceeds $175M; net proceeds ~$164.2M.
Launch-HTN Phase 3: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction (p<0.0001) at week 6 and 11.7 mmHg at week 12.
Mineralys reports FY2024 net loss $177.8M; cash $198.2M; pivotal data expected Q1-Q2 2025
Net loss for FY2024 was $177.8M vs $71.9M in FY2023; R&D spend $168.6M vs $70.4M.
FDA cleared IND for Phase 2 trial of lorundrostat in moderate-to-severe OSA with hypertension.
Mineralys Q3 net loss widens to $56.3M; pivotal trial enrollments complete, data due H1 2025
Net loss of $56.3M for Q3 2024 vs $22.8M in Q3 2023; R&D expense rose to $54.0M from $22.5M.
Mineralys completes Launch-HTN enrollment ahead of schedule; topline data mid-H1 2025
Enrollment completed ahead of schedule in global Phase 3 Launch-HTN trial of lorundrostat for uncontrolled or resistant hypertension.
Mineralys completes enrollment of 261 subjects in pivotal Advance-HTN trial; topline Q1 2025
Target enrollment of 261 subjects achieved in Phase 2 Advance-HTN trial of lorundrostat for uncontrolled or resistant hypertension.
FDA agreed to change Launch-HTN primary endpoint to automated office systolic BP at 6 weeks, pooled 50 mg QD; topline data expected H2 2025.
Mineralys Q1 net loss $31.5M; cash $338.6M; Advance-HTN topline due Q4 2024
Net loss of $31.5M for Q1 2024, up from $12.6M in Q1 2023; R&D expenses $30.8M.
Net loss of $71.9M for FY 2023 vs $29.8M in 2022; R&D expenses increased to $70.4M.
Mineralys Therapeutics raises $120M in private placement; funds lorundrostat development
PIPE of ~8.9M shares/pre-funded warrants at $13.50/share; gross proceeds ~$120M.
Mineralys doses first subject in Phase 3 Launch-HTN trial; topline data expected 2H 2025
First subject dosed in Launch-HTN (NCT06153693), a global Phase 3 trial enrolling up to ~1,000 patients.
Mineralys Therapeutics presents new leptin analysis from Target-HTN trial of lorundrostat
Elevated BMI (>30 kg/m²) predicted enhanced systolic BP reduction: placebo-adjusted drops of 16.7 mmHg (50 mg) and 12.3 mmHg (100 mg).
Mineralys presents post-hoc analysis linking BMI to enhanced BP reduction with lorundrostat
Post-hoc analysis from Target-HTN Phase 2 trial: median systolic BP reduction of 32 mmHg in responder population.
Mineralys Therapeutics Q2 net loss $12.1M; cash $282.8M; Advance-HTN enrollment on track
Net loss of $12.1M for Q2 2023 vs $6.5M in Q2 2022, driven by increased R&D and G&A spend.
Mineralys first patient dosed in ADVANCE-HTN pivotal trial of lorundrostat for hypertension
ADVANCE-HTN trial to enroll up to 300 adults with uncontrolled or resistant hypertension.
Mineralys FY2022 net loss $29.8M; cash $110.1M plus $202M IPO; lorundrostat pivotal trials H1 2023
Net loss for FY2022 was $29.8M vs $19.4M in FY2021, driven by higher R&D and G&A costs.
Mineralys Therapeutics closes IPO of 13.8M shares at $16, raising $220.8M
Completed IPO of 13,800,000 shares (including full exercise of underwriters' option) at $16.00 per share.
On October 16, 2026, the Board of Directors (the Board) of Mineralys Therapeutics, Inc. (the Company) appointed Kristine Peterson and Lonnel Coats to the Board effective as of October 19, 2026, increasing the size of the Board from seven to nine directors.
Mr. Coats was appointed as a Class II director, with a term expiring at the Company’s 2028 annual meeting of stockholders, and was also appointed to serve as a member of the Compensation Committee.
Olivier Litzka, Ph.D. informed the Board of his decision to resign from the Board, effective June 13, 2024.
the Board appointed Alexander M. Gold, M.D. as a member of the Board and the Nominating and Corporate Governance Committee of the Board.
On March 29, 2024, Alexander Asam, Ph.D. informed the Board of Directors (the “Board”) of Mineralys Therapeutics, Inc. (the “Company”) of his decision not to stand for re-election to the Board when his current term expires at the Company’s 2024 annual meeting of stockholders.
As a result, effective January 4, 2024, Adam Levy no longer serves as the Company’s Chief Business Officer.
On January 4, 2024, in connection with the appointment of Minji Kim, Ph.D., as Chief Business Officer, the Board of Directors of Mineralys Therapeutics, Inc. (the “Company”) approved splitting the functions of Chief Financial Officer and Chief Business Officer into two roles.
On September 12, 2023, Takeshi Takahashi, M.B.A., resigned from the Board of Directors (the "Board") of Mineralys Therapeutics, Inc. (the "Company").
the Board appointed Daphne Karydas and Glenn P. Sblendorio as members of the Board.
the Board appointed Daphne Karydas and Glenn P. Sblendorio as members of the Board.
Max materiality 0.90 · Median 0.65 · Most common event other_material