Departed
Olivier Litzka
Director
MLYS ·
Mineralys Therapeutics, Inc.
Olivier Litzka, Ph.D. informed the Board of his decision to resign from the Board, effective June 13, 2024.
Ready 8-Ks
46
Latest filing
August 11, 2026, 4:08 PM ET
Top materiality
0.90
Event mix
other_material ×23 · earnings ×15 · leadership ×4
Sentiment
15 pos · 0 neg · 31 neu
Latest earnings
reported 2026-Q1
Executive change
recent →
Recent 8-K filings for MLYS
Highest-materiality recent filing
Lorundrostat meets primary endpoints in Launch-HTN Phase 3 & Advance-HTN Phase 2 with significant BP reduction
- 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.
- Advance-HTN Phase 2: 50 mg achieved 7.9 mmHg placebo-adjusted SBP reduction by 24hr ABPM at week 12 (p<0.0001).
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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.
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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.
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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.
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Mineralys Therapeutics 2026 annual meeting results: directors elected, auditor ratified
Elected three Class III directors to serve until 2029: Akkaraju (67.1M for), Slingsby (67.1M for), Karydas (66.6M for).
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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.
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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.
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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.
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Mineralys files NDA for lorundrostat, expects Explore-OSA data Q1 2026
Filed new drug application for lorundrostat with FDA in late 2025.
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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.
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Mineralys prices upsized $250M public offering at $25.50/share
9,803,921 shares at $25.50/share; total gross proceeds ~$250M.
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Mineralys Therapeutics terminates ATM prospectus supplement, halts sales until new filing
Delivered written notice to BofA Securities and Evercore terminating prospectus supplement dated April 11, 2024.
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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.
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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.
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Stockholders elect two Class II directors; ratify EY as auditor for FY2025
Glenn P. Sblendorio elected with 45.4M for (85.8% of votes cast) and Derek DiRocco with 45.3M for (85.6%).
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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).
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Lorundrostat 50 mg achieved a 7.9 mmHg placebo-adjusted reduction in 24-hour SBP at week 12 (p=0.001).
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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.
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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.
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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.
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Phase 2 trial evaluating lorundrostat for hypertension in Stage 2-3b CKD with albuminuria on stable ACEi/ARB and SGLT2i.
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FDA cleared IND for Phase 2 trial of lorundrostat in moderate-to-severe OSA with hypertension.
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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.
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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.
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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.
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Mineralys reports Q2 net loss $41M; Advance-HTN trial ~90% enrolled, on track for Q1 2025 data
Net loss of $41.0M for Q2 2024 vs $12.1M in Q2 2023; cash and investments of $311.1M as of June 30, 2024.
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Mineralys Therapeutics appoints Dr. Alexander Gold to board; Dr. Olivier Litzka resigns
Appointed Alexander M. Gold, M.D. as Class I director and to Nominating and Corporate Governance Committee, effective June 13, 2024.
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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.
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Mineralys files legal opinion for ATM equity offering with BofA and Evercore
Legal opinion filed regarding issuance of common stock under ATM offering agreement dated March 21, 2024.
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Proposal 1: Jon Congleton elected as Class I director with 26,418,385 votes for, 3,775,533 withheld, 1,838,014 broker non-votes.
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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.
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Director Alexander Asam not standing for re-election at 2024 annual meeting
Alexander Asam, Ph.D. informed the Board on March 29, 2024 of his decision.
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Net loss of $71.9M for FY 2023 vs $29.8M in 2022; R&D expenses increased to $70.4M.
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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.
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Mineralys Therapeutics appoints Minji Kim Ph.D. as CBO; splits CFO/CBO roles
Adam Levy remains CFO and Secretary; no longer serves as CBO as of Jan 4, 2024.
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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.
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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).
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Net loss $22.8M (Q3 2023) vs $6.7M (Q3 2022); R&D expenses $22.5M, up from $6.1M.
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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.
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Mineralys appoints Karydas and Sblendorio to board after Takahashi resignation
Takeshi Takahashi resigned from board on Sept 12; no disagreement cited.
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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.
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Mineralys expands lorundrostat Phase 2 trial to include SGLT2i combo for CKD, start H2 2023
Two-part Phase 2 trial: Part A (proof-of-concept) up to 100 subjects with mild-moderate CKD; Part B (safety) up to 20 subjects with moderate-severe CKD.
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Mineralys Q1 net loss $12.6M from $7.6M YoY; cash $301.8M; Lorundrostat pivotal trial dosed
Net loss $12.6M vs $7.6M in Q1 2022; R&D expense $12.3M (up from $6.8M) driven by $4.0M milestone payment to Mitsubishi Tanabe.
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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.
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Mineralys Therapeutics discloses 2022 executive bonuses and raises 2023 target bonus percentages
2022 bonuses: CEO Congleton $193.2k, CFO Levy $190.9k, CMO Rodman $190.8k.
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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.
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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.
Executive changes
Appointed
Alexander M. Gold
Class I director
MLYS ·
Mineralys Therapeutics, Inc.
the Board appointed Alexander M. Gold, M.D. as a member of the Board and the Nominating and Corporate Governance Committee of the Board.
Departed
Alexander Asam
Director
MLYS ·
Mineralys Therapeutics, Inc.
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.
Role change
Adam Levy
Chief Business Officer
MLYS ·
Mineralys Therapeutics, Inc.
As a result, effective January 4, 2024, Adam Levy no longer serves as the Company’s Chief Business Officer.
Appointed
Minji Kim
Chief Business Officer
MLYS ·
Mineralys Therapeutics, Inc.
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.
Departed
Takeshi Takahashi
Director
MLYS ·
Mineralys Therapeutics, Inc.
On September 12, 2023, Takeshi Takahashi, M.B.A., resigned from the Board of Directors (the "Board") of Mineralys Therapeutics, Inc. (the "Company").
Appointed
Glenn P. Sblendorio
Director
MLYS ·
Mineralys Therapeutics, Inc.
the Board appointed Daphne Karydas and Glenn P. Sblendorio as members of the Board.
Appointed
Daphne Karydas
Director
MLYS ·
Mineralys Therapeutics, Inc.
the Board appointed Daphne Karydas and Glenn P. Sblendorio as members of the Board.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.65 · Most common event other_material