{"filings":[{"id":2189600,"accession_number":"0001933414-26-000112","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-08-11T20:08:44+00:00","items":["2.02","5.02","9.01"],"status":"ready","headline":"Mineralys Q2 net loss $241M; lorundrostat PDUFA Dec 22, 2026; new CMO appointed","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q2 2026 net loss $241.1M vs $43.3M in Q2 2025; R&D $221.4M incl $200M Tanabe upfront payment.","Cash $661.4M at June 30; raised ~$150M offering and drew $100M tranche of $500M Pharmakon loan.","FDA PDUFA target date Dec 22, 2026 for lorundrostat NDA; commercial launch preparations on track.","Amended Tanabe license: $200M paid to eliminate royalties; remaining milestones up to $255M.","Appointed Dr. Terry Ferguson CMO effective Aug 10; David Rodman stays as Strategic Advisor."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":833638,"accession_number":"0001628280-26-040225","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-06-03T20:07:02+00:00","items":["8.01","9.01"],"status":"ready","headline":"Mineralys prices $150M common stock offering at $26.50/sh; proceeds to fund royalty repurchase","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["5,660,378 shares at $26.50/share; gross proceeds ~$150M, net ~$142.5M.","Proceeds to partially fund $200M upfront payment to repurchase royalty obligation from Tanabe Pharma.","Offering expected to close June 4, 2026; joint book-runners: BofA, Goldman Sachs, Evercore ISI.","Company separately announced a $500M committed debt facility with Pharmakon Advisors.","Underwriters purchased at $25.3075/share; shelf registration effective on filing."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":814959,"accession_number":"0001628280-26-040024","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-06-03T10:02:29+00:00","items":["1.01","2.03"],"status":"ready","headline":"Mineralys terminates lorundrostat royalties, secures up to $500M debt facility","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Amended Tanabe license: $200M one-time payment; royalties eliminated; license perpetual; up to $365M in milestones remain.","Secured $500M senior secured loan; $100M drawn; further tranches tied to FDA approval and net sales.","Loan matures 2031; interest SOFR+5.5% (floor 3.25%); secured by all assets including IP.","Change of control would accelerate $100M new milestone payments."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":611116,"accession_number":"0001933414-26-000090","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-05-22T20:50:14+00:00","items":["5.07"],"status":"ready","headline":"Mineralys Therapeutics 2026 annual meeting results: directors elected, auditor ratified","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Elected three Class III directors to serve until 2029: Akkaraju (67.1M for), Slingsby (67.1M for), Karydas (66.6M for).","Ratified Ernst & Young as independent auditor for fiscal year 2026 with 72.6M votes for, 9.5K against.","Broker non-votes of 5.6M shares on director election proposals; no non-votes on auditor ratification.","All proposals passed with requisite affirmative votes as described in the April 8, 2026 proxy statement."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":96789,"accession_number":"0001933414-26-000082","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-05-06T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics Q1 net loss $39.3M; FDA accepts lorundrostat NDA with Dec 22, 2026 PDUFA","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $39.3M for Q1 2026 vs $42.2M Q1 2025; cash $646.1M, sufficient into 2028.","FDA accepted NDA for lorundrostat in hypertension; PDUFA target date Dec 22, 2026.","R&D expenses $24.4M (down 36% YoY) due to conclusion of pivotal program; G&A $21.0M (up 218% YoY) on pre-commercial costs.","Pre-commercial activities underway: market access, medical advocacy, sales prep for potential launch.","Conference call at 4:30 p.m. ET today; webcast available on company website."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.47,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111027,"accession_number":"0001933414-26-000054","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-03-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics reports Q4/FY2025 results; FDA accepts lorundrostat NDA, PDUFA Dec 22, 2026","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["FDA accepted NDA for lorundrostat for hypertension; PDUFA target date December 22, 2026.","Cash, cash equivalents and investments totaled $656.6M at Dec 31, 2025, expected to fund operations into 2028.","Net loss for FY2025 was $154.7M vs $177.8M in FY2024; Q4 net loss $32.2M vs $48.9M.","Explore-OSA Phase 2 trial did not meet primary AHI endpoint at 4 weeks; showed clinically meaningful BP reduction.","R&D expenses fell to $132.0M in FY2025 from $168.6M in FY2024, driven by conclusion of pivotal program."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111026,"accession_number":"0001933414-26-000048","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-03-09T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA accepts Mineralys' NDA for hypertension drug lorundrostat; PDUFA Dec 22, 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA accepted NDA for lorundrostat for hypertension in combination with other antihypertensives; PDUFA target date December 22, 2026.","Phase 2 Explore-OSA trial did not meet primary endpoint; lorundrostat did not reduce apnea-hypopnea index vs placebo.","Lorundrostat showed 11.1 mmHg BP reduction vs 1.0 mmHg for placebo (p<0.0001) at week 4; placebo-adjusted reduction 6.2 mmHg (p<0.0003).","Safety favorable: no serum potassium >5.5 mmol/L; analysis ongoing for other endpoints.","Company believes lorundrostat has potential for resistant/uncontrolled hypertension; topline data from Explore-OSA reported."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":111025,"accession_number":"0001933414-26-000002","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2026-01-06T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys files NDA for lorundrostat, expects Explore-OSA data Q1 2026","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Filed new drug application for lorundrostat with FDA in late 2025.","Topline results from Phase 2 Explore-OSA trial in hypertension & moderate-severe OSA expected Q1 2026.","Phase 2 Explore-CKD met primary endpoint on systolic BP reduction and showed meaningful proteinuria reduction.","Phase 3 Launch-HTN and Advance-HTN trials both met primary endpoints in uncontrolled/resistant hypertension.","Management to participate in LifeSci Partners Corporate Access event Jan 12-14, 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":127653,"accession_number":"0001933414-25-000139","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-11-10T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics Q3 net loss $36.9M; NDA planned late-2025/Q1 2026; cash $593.6M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $36.9M for Q3 2025 vs $56.3M YoY; R&D expenses fell to $31.5M from $54.0M.","Cash, cash equivalents and investments $593.6M at Sep 30, 2025 (Dec 31, 2024: $198.2M) after $287.5M equity financing.","NDA submission for lorundrostat planned late 2025 or Q1 2026 following pre-NDA FDA feedback.","Enrollment complete in Explore-OSA Phase 2 trial; topline data anticipated Q1 2026.","Company expects current cash to fund planned clinical and regulatory activities into 2028."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.94,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144432,"accession_number":"0001933414-25-000120","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-09-03T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Mineralys prices upsized $250M public offering at $25.50/share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["9,803,921 shares at $25.50/share; total gross proceeds ~$250M.","Net proceeds ~$234.7M (~$269.9M if underwriters' option exercised).","Proceeds to fund lorundrostat clinical development, R&D, manufacturing, and pre-commercialization.","Underwriters: BofA, Evercore, Goldman, Stifel, Wells Fargo; closing expected Sept 4, 2025.","Upsized offering reflects strong demand; underwriters have 30-day option for 1.47M additional shares."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144431,"accession_number":"0001933414-25-000107","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-09-02T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Mineralys Therapeutics terminates ATM prospectus supplement, halts sales until new filing","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Delivered written notice to BofA Securities and Evercore terminating prospectus supplement dated April 11, 2024.","No further sales of common stock under the Sales Agreement will occur until a new prospectus supplement is filed.","The underlying ATM Equity Offering Sales Agreement (March 21, 2024) remains in full force and effect."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.1,"calibrated_materiality_score":0.1,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":144430,"accession_number":"0001933414-25-000088","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-08-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics Q2 net loss $43.3M; cash $324.9M; pre-NDA meeting set for Q4 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $43.3M vs $41.0M in Q2 2024; R&D expenses $38.3M, G&A $8.5M.","Cash, equivalents and investments $324.9M, sufficient to fund operations into 2027.","Explore-CKD Phase 2 met primary endpoints: 9.25 mmHg systolic BP reduction, 30.51% UACR reduction.","Pre-NDA meeting with FDA scheduled for Q4 2025; Explore-OSA top-line data expected in 1H 2026.","Pivotal Launch-HTN and Advance-HTN results published in JAMA and NEJM."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.44,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":162786,"accession_number":"0001933414-25-000070","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-06-17T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Positive Phase 2 Explore-CKD results for lorundrostat; primary endpoint met","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Lorundrostat 25 mg reduced systolic BP by 9.3 mmHg (–7.5 mmHg placebo-adjusted, p=0.0024) in hypertensive CKD patients.","UACR reduction of 31% (–25.6% placebo-adjusted, p=0.0015) suggests renal protective potential.","Favorable safety profile: 3% SAEs (lorundrostat), 5% hyperkalemia rate; 3% discontinuation due to TEAEs.","Data augment pivotal Phase 3 Launch-HTN and other trials; company plans NDA submission including these results."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":162785,"accession_number":"0001933414-25-000064","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-05-22T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"Stockholders elect two Class II directors; ratify EY as auditor for FY2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Glenn P. Sblendorio elected with 45.4M for (85.8% of votes cast) and Derek DiRocco with 45.3M for (85.6%).","Ernst & Young ratified as independent auditor for FY2025: 59.1M for, 5.9K against, 191K abstentions.","Over 6.3M broker non-votes on director elections; none on auditor ratification.","Annual meeting held May 22, 2025; all proposals passed with requisite majority."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.2,"calibrated_materiality_score":0.15,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":162784,"accession_number":"0001933414-25-000057","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-05-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys reports positive pivotal trial results; Q1 net loss $42.2M; cash $343M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Launch-HTN: 50 mg lorundrostat achieved 9.1 mmHg placebo-adjusted SBP reduction at week 6 (p<0.0001).","Advance-HTN: 50 mg cohort met primary endpoint; 7.9 mmHg placebo-adjusted SBP reduction (p=0.001).","Cash, equivalents and investments $343.0M as of March 31, 2025, vs $198.2M at Dec 31, 2024.","Net loss for Q1 2025 was $42.2M, up from $31.5M in Q1 2024; R&D expenses rose to $37.9M.","Appointed Eric Warren as Chief Commercial Officer; pre-NDA meeting with FDA expected Q4 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.79,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.88,"calibrated_materiality_score":0.88,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180756,"accession_number":"0001933414-25-000026","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-03-31T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys Therapeutics reports positive Phase 2 Advance-HTN trial results for lorundrostat in hypertension","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Lorundrostat 50 mg achieved a 7.9 mmHg placebo-adjusted reduction in 24-hour SBP at week 12 (p=0.001).","41% of lorundrostat patients achieved 24-hour SBP <125 mmHg at week 4 vs 18% on placebo (p<0.001).","Trial enrolled 53% Black and 40% female patients; safety showed low discontinuation and confirmed hyperkalemia rates of 2.1% and 3.2%.","Company plans to provide additional Phase 3 Launch-HTN data at an upcoming medical conference."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180755,"accession_number":"0001628280-25-012335","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-03-12T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"Mineralys prices $175M public offering (12.96M shares at $13.50); net proceeds ~$164.2M","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering of 12,962,962 shares at $13.50; gross proceeds $175M; net proceeds ~$164.2M.","Underwriters have 30-day option for additional 1,944,444 shares, adding up to $26.3M.","Proceeds to fund lorundrostat clinical development, R&D, manufacturing, and pre-commercialization.","Joint book-runners: BofA Securities, Evercore ISI, Goldman Sachs, Stifel, Wells Fargo.","Expected to close March 13, 2025; subject to customary conditions."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180754,"accession_number":"0001628280-25-011459","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-03-10T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Lorundrostat meets primary endpoints in Launch-HTN Phase 3 & Advance-HTN Phase 2 with significant BP reduction","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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).","Safety profile favorable: SAEs 2.2% (50 mg) vs 3.0% placebo; hyperkalemia (>6.0 mmol/L) 1.1% in Launch-HTN, 5.3% in Advance-HTN.","Diverse enrollment: Launch-HTN 47% women, 29% Black/African American; Advance-HTN 40% women, 50% Black/African American.","Full Advance-HTN results to be presented at ACC Scientific Sessions on March 29, 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.9,"calibrated_materiality_score":0.9,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180753,"accession_number":"0001933414-25-000008","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-02-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys reports FY2024 net loss $177.8M; cash $198.2M; pivotal data expected Q1-Q2 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss for FY2024 was $177.8M vs $71.9M in FY2023; R&D spend $168.6M vs $70.4M.","Cash, equivalents and investments $198.2M as of Dec 31, 2024; expected to fund operations through Q1 2026.","Topline data from pivotal Advance-HTN trial expected March 2025; Launch-HTN Phase 3 data in mid first half 2025.","Enrollment in Explore-CKD Phase 2 complete; topline data anticipated Q2 2025.","Initiating Phase 2 trial for lorundrostat in moderate-to-severe OSA and hypertension in Q1 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-3.66,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-FY","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180752,"accession_number":"0001933414-25-000006","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-02-04T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys completes enrollment in Explore-CKD Phase 2 trial of lorundrostat; topline data expected Q2 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Phase 2 trial evaluating lorundrostat for hypertension in Stage 2-3b CKD with albuminuria on stable ACEi/ARB and SGLT2i.","Primary endpoint: change from baseline in systolic BP at week 4 vs placebo; exploratory endpoint includes UACR change.","Third trial to recently complete enrollment, alongside Target-HTN, Advance-HTN, and Explore-OSA.","Topline data anticipated in Q2 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":180751,"accession_number":"0001933414-25-000002","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2025-01-08T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA clears IND for Mineralys' lorundrostat Phase 2 trial in obstructive sleep apnea with hypertension","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["FDA cleared IND for Phase 2 trial of lorundrostat in moderate-to-severe OSA with hypertension.","Trial to evaluate effect on apnea-hypopnea frequency & nocturnal hypertension; initiation expected Q1 2025.","Approximately 40 subjects, placebo-controlled crossover design at up to 40 sites.","Cash, cash equivalents & investments expected to fund operations through Q1 2026.","This is the third targeted indication for lorundrostat, following hypertension and CKD."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":197595,"accession_number":"0001933414-24-000056","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-11-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Q3 net loss widens to $56.3M; pivotal trial enrollments complete, data due H1 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $56.3M for Q3 2024 vs $22.8M in Q3 2023; R&D expense rose to $54.0M from $22.5M.","Cash & investments $263.6M; company believes sufficient to fund operations into 2026.","Advance-HTN pivotal trial fully enrolled; topline data expected March 2025.","Launch-HTN Phase 3 trial enrolled ahead of schedule; topline data anticipated mid first half 2025.","Explore-CKD Phase 2 trial enrollment ongoing; topline data expected Q2 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.68,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":197594,"accession_number":"0001933414-24-000050","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-10-30T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys completes Launch-HTN enrollment ahead of schedule; topline data mid-H1 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Enrollment completed ahead of schedule in global Phase 3 Launch-HTN trial of lorundrostat for uncontrolled or resistant hypertension.","Topline data now anticipated in mid first half of 2025, earlier than originally planned.","Trial randomized patients to placebo, lorundrostat 50 mg QD, or 50 mg titrated to 100 mg QD; primary endpoint SBP change at 6 weeks.","Company hosting virtual KOL event on Oct 30 to discuss unmet need and lorundrostat pivotal program."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":213819,"accession_number":"0001933414-24-000044","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-09-25T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys completes enrollment of 261 subjects in pivotal Advance-HTN trial; topline Q1 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Target enrollment of 261 subjects achieved in Phase 2 Advance-HTN trial of lorundrostat for uncontrolled or resistant hypertension.","Topline data expected Q1 2025; additional subjects in screening may enroll over next several weeks.","Trial is randomized, double-blind, placebo-controlled, add-on to standardized antihypertensive regimen.","Virtual KOL event scheduled for October 30, 2024 to discuss unmet need and clinical program."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":213818,"accession_number":"0001933414-24-000038","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-08-13T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys reports Q2 net loss $41M; Advance-HTN trial ~90% enrolled, on track for Q1 2025 data","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["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.","Advance-HTN pivotal trial ~90% enrolled; topline data expected Q1 2025 after FDA alignment on primary endpoint.","Launch-HTN Phase 3 enrollment ahead of schedule; topline data on track for 2H 2025.","Explore-CKD Phase 2 trial enrollment ramping; topline data expected 1H 2025.","Cash runway into 2026 covers planned clinical studies and corporate operations."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.54,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233039,"accession_number":"0001933414-24-000028","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-06-14T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Mineralys Therapeutics appoints Dr. Alexander Gold to board; Dr. Olivier Litzka resigns","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Appointed Alexander M. Gold, M.D. as Class I director and to Nominating and Corporate Governance Committee, effective June 13, 2024.","Dr. Gold received options to purchase 44,000 shares vesting over three years; cash compensation per non-employee director program.","Dr. Olivier Litzka resigned from board effective June 13, 2024, with no disagreement with company or management.","Board size decreased from eight to seven following resignation and prior departure of Alexander Asam, Ph.D. on May 22, 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233038,"accession_number":"0001933414-24-000025","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-06-10T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Mineralys revises primary endpoints for two pivotal hypertension trials; topline data expected Q4 2024 and H2 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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.","Plan similar revision for Advance-HTN (Phase 2) pending FDA alignment: 24-hour ambulatory systolic BP at 4 weeks, pooled 50 mg QD; topline Q4 2024.","Both trials evaluate lorundrostat for uncontrolled or resistant hypertension; no other design changes or operational impact.","Launch-HTN Phase 3 enrolls up to 1,000 subjects; Advance-HTN Phase 2 had 261 subjects."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233037,"accession_number":"0001933414-24-000024","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-05-31T23:59:59+00:00","items":["9.01"],"status":"ready","headline":"Mineralys files legal opinion for ATM equity offering with BofA and Evercore","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Legal opinion filed regarding issuance of common stock under ATM offering agreement dated March 21, 2024.","ATM agreement with BofA Securities and Evercore Group LLC remains in place.","Prospectus supplement for ATM program previously filed on March 21, 2024.","No new financial or operational disclosures; routine regulatory filing."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.05,"calibrated_materiality_score":0.05,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233036,"accession_number":"0001933414-24-000017","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-05-22T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"Stockholders elect Jon Congleton as Class I director and ratify Ernst & Young as auditor at 2024 annual meeting","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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.","Proposal 2: Ratification of Ernst & Young as independent auditor approved with 32,025,366 for, 1,187 against, 5,379 abstain.","Annual meeting held May 22, 2024; both proposals passed with requisite votes."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.15,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233035,"accession_number":"0001933414-24-000015","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-05-09T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Q1 net loss $31.5M; cash $338.6M; Advance-HTN topline due Q4 2024","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $31.5M for Q1 2024, up from $12.6M in Q1 2023; R&D expenses $30.8M.","Cash, equivalents and investments $338.6M as of March 31, 2024; private placement net ~$116M in Q1.","Advance-HTN pivotal trial topline data expected in Q4 2024.","Launch-HTN Phase 3 trial topline data anticipated in 2H 2025.","Explore-CKD Phase 2 topline data expected Q4 2024 to Q1 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.7,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":233034,"accession_number":"0001933414-24-000008","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-04-04T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Director Alexander Asam not standing for re-election at 2024 annual meeting","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Alexander Asam, Ph.D. informed the Board on March 29, 2024 of his decision.","He will not stand for re-election when his term expires at the 2024 annual meeting.","Asam stated the decision was not due to any disagreement with the Company or management."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.3,"calibrated_materiality_score":0.3,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":251200,"accession_number":"0001628280-24-012373","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-03-21T23:59:59+00:00","items":["1.01","2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics reports FY 2023 net loss of $71.9M; topline data expected Q4 2024 for Advance-HTN","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $71.9M for FY 2023 vs $29.8M in 2022; R&D expenses increased to $70.4M.","Cash, cash equivalents and investments $239.0M at Dec 31, 2023; subsequent private placement raised ~$120M.","Entered into ATM equity offering sales agreement to sell up to $100M of common stock.","Pivotal Advance-HTN trial topline data expected Q4 2024; Launch-HTN data in 2H 2025.","Explore-CKD Phase 2 trial design modified; topline data expected Q4 2024 to Q1 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":251199,"accession_number":"0001933414-24-000006","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-02-08T23:59:59+00:00","items":["1.01","3.02","7.01","9.01"],"status":"ready","headline":"Mineralys Therapeutics raises $120M in private placement; funds lorundrostat development","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["PIPE of ~8.9M shares/pre-funded warrants at $13.50/share; gross proceeds ~$120M.","Lead investors TCGX and RA Capital Management, joined by OrbiMed, Venrock, Samsara, and others.","Net proceeds to fund R&D of lorundrostat (aldosterone-driven hypertension/CKD) and general corporate purposes.","PIPE expected to close Feb 12, 2024; BofA Securities and Evercore as placement agents.","Registration statement to be filed within 60 days of closing for resale of shares and warrant shares."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":251198,"accession_number":"0001933414-24-000002","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2024-01-04T23:59:59+00:00","items":["5.02","7.01","9.01"],"status":"ready","headline":"Mineralys Therapeutics appoints Minji Kim Ph.D. as CBO; splits CFO/CBO roles","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Adam Levy remains CFO and Secretary; no longer serves as CBO as of Jan 4, 2024.","Dr. Kim brings >20 years biotech BD experience including Jounce Therapeutics and Curis.","Company expects clinical milestones for hypertension drug lorundrostat over next 12–18 months.","Role split supports expanded operations as Mineralys advances late-stage development."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":268774,"accession_number":"0001933414-23-000096","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-12-22T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys doses first subject in Phase 3 Launch-HTN trial; topline data expected 2H 2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First subject dosed in Launch-HTN (NCT06153693), a global Phase 3 trial enrolling up to ~1,000 patients.","Trial evaluates lorundrostat as add-on for uncontrolled or resistant hypertension on 2-5 background drugs.","Three arms: placebo, lorundrostat 50 mg QD, or 50 mg titrated to 100 mg QD at week 6.","Primary endpoint: change in systolic BP vs placebo at 12 weeks by automated office measurement.","Topline data from Advance-HTN (first pivotal trial) expected in 2H 2024; Transform-HTN OLE ongoing."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":268773,"accession_number":"0001933414-23-000090","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-11-13T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"Mineralys Therapeutics presents new leptin analysis from Target-HTN trial of lorundrostat","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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).","New analysis shows increased serum leptin correlates with higher BMI, suggesting leptin as a biomarker for responsive patients.","Target-HTN results support transition to late-stage development; Advance-HTN pivotal trial enrolling, Launch-HTN expected H2 2023.","Data presented at AHA Scientific Sessions 2023 in Philadelphia."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":268772,"accession_number":"0001933414-23-000085","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-11-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Q3 net loss $22.8M; cash $265.9M; Phase 3 Launch-HTN start on track for 2H2023, topline delayed to 2H2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $22.8M (Q3 2023) vs $6.7M (Q3 2022); R&D expenses $22.5M, up from $6.1M.","Cash, cash equivalents and investments $265.9M as of Sep 30, 2023; expected to fund operations through mid-2025.","Advance-HTN topline data revised from 1H2024 to 2H2024 due to protocol amendment and enrollment curve.","Phase 3 Launch-HTN trial remains on track to initiate in 2H2023; topline data now expected in 2H2025.","Explore-CKD Phase 2 trial expected to start in 2H2023 with topline data in Q4 2024–Q1 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.36,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2023-Q3","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":268771,"accession_number":"0001933414-23-000081","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-11-02T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Mineralys presents post-hoc analysis linking BMI to enhanced BP reduction with lorundrostat","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Post-hoc analysis from Target-HTN Phase 2 trial: median systolic BP reduction of 32 mmHg in responder population.","Enhanced response proportional to BMI; modeled reduction ~12 mmHg at BMI 30 and ~19 mmHg at BMI 40 kg/m².","Statistically significant linear regression association between BMI and systolic BP reduction (BMI 22.5-40 kg/m²).","Advance-HTN pivotal trial enrolling; Phase 3 Launch-HTN trial expected to start before end of 2023.","Data supports obesity-associated aldosterone-dependent hypertensive endotype as predictor of response."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":285882,"accession_number":"0001933414-23-000076","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-09-14T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Mineralys appoints Karydas and Sblendorio to board after Takahashi resignation","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Takeshi Takahashi resigned from board on Sept 12; no disagreement cited.","Board expanded to 8 members; appointed Daphne Karydas (Class III) and Glenn Sblendorio (Class II) effective Sept 13.","Karydas named audit committee chair; Sblendorio named compensation committee chair.","Each new director received options to purchase 44,000 shares vesting monthly over 3 years."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.5,"calibrated_materiality_score":0.5,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":285881,"accession_number":"0001933414-23-000054","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-08-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Therapeutics Q2 net loss $12.1M; cash $282.8M; Advance-HTN enrollment on track","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $12.1M for Q2 2023 vs $6.5M in Q2 2022, driven by increased R&D and G&A spend.","Cash, equivalents and investments $282.8M as of June 30, 2023, up from $110.1M at Dec 31, 2022.","R&D expenses $11.9M vs $5.6M YoY, reflecting initiation of lorundrostat pivotal program.","Advance-HTN Phase 2 trial enrollment ongoing; topline data expected 1H 2024.","Phase 3 Launch-HTN trial and Phase 2 CKD trial both expected to start in 2H 2023."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.77,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2023-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":285880,"accession_number":"0001933414-23-000048","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-07-17T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"Mineralys expands lorundrostat Phase 2 trial to include SGLT2i combo for CKD, start H2 2023","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["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.","Part A tests lorundrostat 50mg alone and in combination with dapagliflozin 10mg vs placebo over 12+12 weeks.","Part B is open-label dose escalation (25mg to 50mg) in renally compromised patients (eGFR 25-44).","Topline data expected between Q4 2024 and Q1 2025.","Program builds on aldosterone's role in CKD progression and positive Target-HTN trial results."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":305808,"accession_number":"0001933414-23-000035","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-05-15T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys Q1 net loss $12.6M from $7.6M YoY; cash $301.8M; Lorundrostat pivotal trial dosed","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["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.","Cash, equivalents & investments $301.8M as of Mar 31, 2023, up from $110.1M; expected to fund operations through mid-2025.","Initiated Advance-HTN Phase 2 pivotal trial (lorundrostat) in April 2023; topline data expected H1 2024.","Plans to initiate Launch-HTN Phase 3 (H2 2023) and a CKD Phase 2 trial (mid-2023); Launch-HTN data expected mid-2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.51,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2023-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.55,"calibrated_materiality_score":0.55,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":305807,"accession_number":"0001933414-23-000028","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-05-02T23:59:59+00:00","items":["8.01"],"status":"ready","headline":"Mineralys first patient dosed in ADVANCE-HTN pivotal trial of lorundrostat for hypertension","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["ADVANCE-HTN trial to enroll up to 300 adults with uncontrolled or resistant hypertension.","Primary endpoint: change in systolic BP vs placebo after 12 weeks (24-hr ambulatory monitoring).","Topline data from ADVANCE-HTN expected in first half of 2024.","Second pivotal Phase 3 trial to begin enrolling H2 2023, data anticipated mid-2025.","Phase 2 CKD trial for lorundrostat expected to start mid-2023, topline data H1 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":325111,"accession_number":"0001933414-23-000024","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-03-22T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Mineralys Therapeutics discloses 2022 executive bonuses and raises 2023 target bonus percentages","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["2022 bonuses: CEO Congleton $193.2k, CFO Levy $190.9k, CMO Rodman $190.8k.","2023 target bonuses increased: Congleton 50% of base salary, Rodman 45%, Levy 40%.","Revised Summary Compensation Table includes previously omitted 2022 bonus amounts.","Equity awards in 2022: Congleton $1.12M stock, Levy $483.5k stock, Rodman $492k options."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"neutral","materiality_score":0.25,"calibrated_materiality_score":0.25,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":325110,"accession_number":"0001933414-23-000009","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-03-15T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"Mineralys FY2022 net loss $29.8M; cash $110.1M plus $202M IPO; lorundrostat pivotal trials H1 2023","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss for FY2022 was $29.8M vs $19.4M in FY2021, driven by higher R&D and G&A costs.","Cash and marketable securities were $110.1M at Dec 31, 2022; Feb 2023 IPO raised net ~$202M.","Positive Phase 2 Target-HTN data presented; FDA end-of-Phase 2 meeting completed.","Pivotal ADVANCE-HTN Phase 2 trial planned H1 2023; Phase 3 trial planned H2 2023."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null},{"id":325109,"accession_number":"0001628280-23-003502","cik":1933414,"company_name":"Mineralys Therapeutics, Inc.","ticker":"MLYS","form_type":"8-K","filed_at":"2023-02-14T23:59:59+00:00","items":["5.03","8.01","9.01"],"status":"ready","headline":"Mineralys Therapeutics closes IPO of 13.8M shares at $16, raising $220.8M","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Completed IPO of 13,800,000 shares (including full exercise of underwriters' option) at $16.00 per share.","Gross proceeds of $220.8 million before underwriting discounts and offering expenses.","Filed amended charter increasing authorized common stock to 500M shares and authorizing 50M shares of preferred stock."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":2502579890.7924023,"market_cap_bucket":"not_microcap","market_cap_source":"finnhub_profile2","market_cap_as_of_date":"2026-05-28","daily_digest_date":null,"daily_digest_url":null,"daily_digest_rank":null}],"next_cursor":null}