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
31
Latest filing
June 3, 2026, 4:07 PM ET
Top materiality
0.90
Event mix
other_material ×15 · earnings ×10 · other ×3
Sentiment
10 pos · 0 neg · 21 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 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 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 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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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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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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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 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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Net loss of $71.9M for FY 2023 vs $29.8M in 2022; R&D expenses increased to $70.4M.
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.
Earnings & guidance
Materiality & sentiment trend
Max materiality 0.90 · Median 0.65 · Most common event other_material