{"filings":[{"id":758916,"accession_number":"0001213900-26-063125","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2026-06-01T10:20:20+00:00","items":["1.01"],"status":"ready","headline":"MoonLake Immunotherapeutics signs commercial supply and capacity agreements with Vetter for sonelokimab","summary_kind":"llm","event_type":"other_material","confidence":"medium","bullets":["Master Commercial Supply Agreement signed May 22, 2026 with Vetter for manufacturing pre-filled application systems.","Capacity Agreement commits MoonLake to binding annual minimum and maximum quantity orders; failure may trigger compensation.","Agreements include pricing adjustment provisions based on Vetter’s cost increases and change-of-control termination rights.","Sonelokimab is MoonLake’s key product candidate; deal supports potential commercialization."],"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":1373663394.4073873,"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":95822,"accession_number":"0001821586-26-000005","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2026-05-11T23:59:59+00:00","items":["2.02","7.01","9.01"],"status":"ready","headline":"MoonLake aligns with FDA on BLA for sonelokimab in HS; Q1 cash $357.9M","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA pre-BLA meeting positive; alignment on submission plans, adolescent data inclusion, and safety strategy.","BLA submission planned for end of Sep 2026; Priority Review decision expected within 60 days.","Proposed label includes ~43% HiSCR75 response and ~29pp delta-to-placebo from MIRA trial, highest in HS.","Cash $357.9M as of Mar 31, 2026; runway to end of 2027; up to $400M non-dilutive debt facility available.","R&D expenses $54.5M (stable); G&A $15.5M with $4.8M accelerated stock option cancellation."],"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":1373663394.4073873,"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":109150,"accession_number":"0001213900-26-018967","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2026-02-23T23:59:59+00:00","items":["1.01","2.02","2.03","5.02","7.01","8.01","9.01"],"status":"ready","headline":"MoonLake reports positive Phase 2 axSpA data: 81% ASAS40 at Week 12; amends Hercules loan for up to $400M","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Phase 2 S-OLARIS trial: 81% of SLK-treated patients achieved ASAS40 response at Week 12 (n=26, mNRI).","Over 80% achieved clinically important improvement per ASDAS-CRP; PET/MRI showed reduced inflammation and osteoblast activity.","Cash, equivalents and short-term marketable debt securities: $394M as of Dec 31, 2025; runway into H2 2027.","Amended Hercules Capital debt facility; drew $25M; up to $400M in future non-dilutive funding available.","Director Simon Sturge to resign effective Feb 28, 2026; Dr. Jorge Santos da Silva appointed Interim Chair."],"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":1373663394.4073873,"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":109149,"accession_number":"0001213900-26-002344","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2026-01-08T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"MoonLake gets FDA clarity on SLK in HS; no new trials needed for BLA submission","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA confirms MoonLake can establish substantial evidence of effectiveness using existing VELA-1, VELA-2, and MIRA trials; no additional HS trials required.","BLA submission for Sonelokimab in HS on track for H2 2026; Investor Day set for Feb 23, 2026 to discuss FDA feedback and new data.","FDA advised including VELA-2 results in BLA to inform safety profile, regardless of role in establishing effectiveness.","Upcoming milestones: Phase 2 S-OLARIS (axSpA) Q1 2026; Phase 3 IZAR-1 (PsA) mid-2026; VELA-TEEN adolescent HS readout mid-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":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":1373663394.4073873,"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":125646,"accession_number":"0001821586-25-000021","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-11-05T23:59:59+00:00","items":["2.02","7.01","9.01"],"status":"ready","headline":"MoonLake Q3 2025: $380.5M cash, positive Phase 2 PPP data for Sonelokimab","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Cash and equivalents $380.5M as of Sept 30, 2025; runway into H2 2027.","R&D expenses $60.6M (up from $49.8M) driven by trial ramp-up and BLA prep.","Phase 2 LEDA PPP: 64% mean PPPASI reduction, 39% PPPASI75 at week 16; no approved therapies.","VELA-TEEN interim: 46% HiSCR75 in adolescent HS at week 16 (n=11); BLA submission Q3/Q4 2026.","FDA Type B meeting Dec 15, 2025 to discuss SLK in HS evidence for BLA."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.61,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":1373663394.4073873,"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":125645,"accession_number":"0001213900-25-106723","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-11-05T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"MoonLake Immunotherapeutics raises $75M in equity offering of 7.1M shares at $10.50/share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering of 7,142,857 Class A ordinary shares at $10.50 per share for gross proceeds of $75M.","Underwriting agreement with Leerink Partners LLC; expected close on November 6, 2025.","Shares offered under existing shelf registration statement on Form S-3 (File No. 333-274286)."],"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":1373663394.4073873,"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":142367,"accession_number":"0001213900-25-092614","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-09-29T23:59:59+00:00","items":["8.01","9.01"],"status":"ready","headline":"MoonLake VELA Ph3: VELA-1 meets primary HiSCR75 (p<0.001); VELA-2 misses but shows significance on treatment policy","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["VELA-1 achieved HiSCR75 at week 16 with 34.8% vs 17.5% placebo, delta 17.3% (p<0.001).","VELA-2 primary composite analysis p=0.053; pre-specified treatment policy gave 35.9% vs 25.6% (p=0.033).","Combined: HiSCR75 35.4% vs 21.6% (p<0.001); all secondary endpoints significant (pain, DLQI, HiSQOL).","Safety favorable: no suicidal ideation, MACE; oral candidiasis 7.3% on sonelokimab vs 0.4% placebo.","Next milestones: Q4 2025 LEDA (PPP), Q1 2026 S-OLARIS (axSpA), Q2 2026 VELA 52-week data."],"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":1373663394.4073873,"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":142366,"accession_number":"0001821586-25-000016","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-08-05T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake Q2 cash $425M; Phase 3 HS readout expected Sept 2025","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["R&D expenses Q2 $49.8M (up from $36.5M Q1) on trial ramp-up and BLA preparation.","Cash & equivalents $425.1M; up to $500M non-dilutive debt facility from Hercules Capital.","Phase 3 VELA (HS) top-line readout on track for ~September 2025; BLA submission planned mid-2026.","Phase 2 LEDA (PPP) interim readout reported; primary readout expected Q4 2025.","Cash runway extended into 2028 to support sonelokimab launch in 2027."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.5,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1373663394.4073873,"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":160400,"accession_number":"0001213900-25-052140","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-06-06T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"MoonLake shareholders elect all director nominees and approve auditor and say-on-pay at AGM","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["All three Class III director nominees elected: Dr. Jorge Santos da Silva, Simon Sturge, Dr. Andrew Phillips with over 53M votes for each.","Ratification of Baker Tilly US, LLP as independent auditor approved: 59,310,209 for, 2,856 against, 8,438 abstentions.","Advisory vote on executive compensation passed with 53,464,199 for, 109,913 against, 8,983 abstentions, 5,738,408 broker non-votes.","Total shares entitled to vote: 63,474,253 Class A and 729,320 Class C ordinary shares as of record date April 10, 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":0.2,"calibrated_materiality_score":0.15,"market_cap_usd":1373663394.4073873,"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":160399,"accession_number":"0001821586-25-000009","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-05-12T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake reports Q1 2025 cash of $480.1M, secures up to $500M debt facility; Phase 3 HS enrollment complete","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Cash, cash equivalents and short-term marketable debt securities of $480.1M as of March 31, 2025.","Up to $500M non-dilutive debt facility with Hercules Capital; $75M drawn at close, extends cash runway into 2028.","Phase 3 VELA program in hidradenitis suppurativa fully enrolled; top-line results expected around September 2025.","R&D expenses $36.5M (similar to prior quarter); G&A expenses $11.0M (up from $9.2M).","Interim readout of Phase 2 LEDA trial in palmoplantar pustulosis presented; primary endpoint readout expected 2H 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.63,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1373663394.4073873,"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":160398,"accession_number":"0001213900-25-036363","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-04-29T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"MoonLake to post investor presentation for Capital Markets Day; no specific figures disclosed","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["MoonLake Immunotherapeutics will post an investor presentation for its Capital Markets Day on April 29, 2025.","Presentation covers financial position, near-term clinical catalysts, and strategic outlook; no numbers in this filing.","Presentation and webcast replays will be available on MoonLake's IR website at https://ir.moonlaketx.com."],"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":1373663394.4073873,"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":160397,"accession_number":"0001213900-25-028366","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-04-03T23:59:59+00:00","items":["1.01","2.03","7.01","9.01"],"status":"ready","headline":"MoonLake secures up to $500M non-dilutive loan from Hercules Capital; $75M drawn at close","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["Up to $500M non-dilutive term loan facility from Hercules Capital; $75M funded at close on March 31, 2025.","Additional tranches up to $125M upon VELA Phase 3 HS success; further tranches for PsA and BLA acceptance.","Facility matures April 1, 2030; interest rate prime+1.45% (floor 8.45%), 0.25% reduction on FDA BLA acceptance.","Company had $448M cash (from 10-K); combined facility expected to fund sonelokimab launch in 2027.","Capital Markets Update April 29, 2025: VELA baseline characteristics, primary endpoint readout timing, and Phase 2 LEDA interim data."],"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":0.78,"calibrated_materiality_score":0.78,"market_cap_usd":1373663394.4073873,"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":178665,"accession_number":"0001821586-25-000004","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2025-02-26T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake reports FY 2024 net loss of $121.2M, cash of $448M; advances sonelokimab to Phase 3","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss for 2024 was $121.2M, compared to $44.1M in 2023, driven by increased R&D spending.","R&D expenses rose to $112.8M in 2024 from $31.8M in 2023 as Phase 3 trials for HS and PsA started.","Cash and equivalents of $448.0M as of Dec 31, 2024, down from $493.9M in Q3 2024; runway to end of 2026.","Initiated Phase 3 VELA (HS), Phase 3 IZAR (PsA), plus Phase 2 trials in PPP, axSpA, and adolescent HS.","Capital Markets Update planned for Q2 2025 to discuss Phase 3 HS data and financials."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.89,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-FY","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1373663394.4073873,"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":195332,"accession_number":"0001213900-24-110169","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-12-18T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"MoonLake director resigns; CEO, CSO, CFO each to receive $4M equity grants in Jan 2025","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Dr. Kara Lassen resigns from Board effective Dec 31, 2024, due to new role at Roche Pharma; no dispute with Company.","Board approved long-term incentive program with annual equity grants; employees may elect restricted stock awards or stock options.","CEO Dr. Jorge Santos da Silva, CSO Dr. Kristian Reich, and CFO Matthias Bodenstedt each expected to receive $4M grant date fair value in Jan 2025, vesting over four years.","Board size reduced from 7 to 6 directors following resignation."],"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":1373663394.4073873,"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":195331,"accession_number":"0001821586-24-000028","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-11-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake Q3 cash $493.9M; Phase 3 HS readout on track for mid-2025","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Cash, equivalents and short-term debt securities of $493.9M as of Sep 30; runway to end of 2026.","R&D expenses of $35.7M in Q3, up from $23.7M prior quarter, driven by Phase 3 HS ramp-up.","Phase 3 VELA program in HS actively enrolling; primary endpoint readout anticipated as of mid-2025.","Phase 3 PsA program (IZAR-1 and IZAR-2) enrollment expected to commence imminently.","Additional Phase 2 trials in PPP, axSpA, and Phase 3 adolescent HS to start around year-end 2024."],"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":1373663394.4073873,"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":211585,"accession_number":"0001213900-24-077513","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-09-11T23:59:59+00:00","items":["7.01"],"status":"ready","headline":"MoonLake Immunotherapeutics posts investor presentation for Capital Markets Day on September 11, 2024","summary_kind":"llm","event_type":"other","confidence":"low","bullets":["Investor presentation covers financial position, near-term catalysts, and publication roadmap.","Presentation and webcast replay available on company's IR website at ir.moonlaketx.com.","No specific financial results or guidance disclosed in the 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":0.2,"calibrated_materiality_score":0.2,"market_cap_usd":1373663394.4073873,"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":211584,"accession_number":"0001821586-24-000024","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-08-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake reports $519.8M cash; initiates Phase 3 VELA in HS, positive FDA/EMA feedback for PsA Phase 3","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Q2 2024 cash, equivalents and short-term debt securities of $519.8M; cash runway to end-2026 unchanged.","R&D expenses $23.7M (up from $13.0M prior quarter) driven by new trial initiations; G&A $6.9M.","Phase 3 VELA program in hidradenitis suppurativa (HS) initiated; topline HiSCR75 primary endpoint expected mid-2025.","Positive FDA and EMA feedback on regulatory path for Phase 3 IZAR program in psoriatic arthritis; topline results expected end-2026.","Capital Markets Update on Sept 11; Phase 3 VELA TEEN in adolescent HS targeted for year-end 2024 initiation."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.6,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1373663394.4073873,"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":230285,"accession_number":"0001213900-24-051263","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-06-10T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA and EMA back MoonLake's Phase 3 program for sonelokimab in psoriatic arthritis","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA and EMA unanimously supported MoonLake's proposed Phase 3 IZAR program for sonelokimab in PsA.","Phase 3 design: ~1,500 patients across two trials (IZAR-1 bio-naïve, IZAR-2 TNF-IR with risankizumab reference).","Doses 60mg and 120mg; primary endpoint ACR50 at week 16; first patient Q4 2024, topline readout end-2026.","Follows positive FDA/EMA feedback for HS Phase 3 VELA program; Phase 3 HS recruitment already started.","Phase 2 ARGO data plus IZAR intended to support BLA and EU MAA for sonelokimab in PsA."],"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":1373663394.4073873,"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":230284,"accession_number":"0001213900-24-050194","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-06-06T23:59:59+00:00","items":["5.07"],"status":"ready","headline":"MoonLake Immunotherapeutics 2024 AGM: all director nominees elected, say-on-pay approved, annual frequency adopted","summary_kind":"llm","event_type":"other","confidence":"high","bullets":["Director nominees Catherine Moukheibir (50.4M for) and Dr. Ramnik Xavier (53.9M for) elected; 4.24M broker non-votes.","Baker Tilly ratified as independent auditor with 52.6M for vs 6.4M abstentions.","Advisory vote on executive compensation passed with 54.7M for (99.99% of votes cast).","Advisory vote on frequency: 54.2M chose 1 year; company will hold annual say-on-pay votes going forward."],"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":0.15,"calibrated_materiality_score":0.15,"market_cap_usd":1373663394.4073873,"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":230283,"accession_number":"0001821586-24-000019","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-05-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake Q1 cash $547.1M; positive FDA/EMA feedback for Phase 3 sonelokimab in HS","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Cash and equivalents $547.1M at March 31, 2024, expected to fund operations to end of 2026.","R&D expense $13.0M in Q1 (up from $8.1M prior Q) due to trial initiations; G&A $6.8M.","Positive FDA and EMA feedback for Phase 3 VELA program in HS; topline data expected mid-2025.","ARGO Phase 2 in PsA: up to 52% ACR50+PASI100 and 61% MDA at week 24, suggesting best-in-class profile.","Plans to initiate four additional trials in PPP, juvenile HS, seronegative spondyloarthritis in 2H 2024."],"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":1373663394.4073873,"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":248696,"accession_number":"0001213900-24-021233","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-03-11T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"MoonLake reports 24-week PsA data with ~60% ACR50; plans Phase 3 HS trials in Q2 2024","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["ARGO trial: ~60% ACR50 at week 24; ~40% ACR70; >80% PASI90; ~60% PASI100; low discontinuation ~5%.","Composite responses: ACR50+PASI100 up to 52%, MDA up to 61%; sonelokimab outperformed adalimumab.","Regulatory feedback from FDA/EMA supports Phase 3 HS program (VELA) enrolling 800 patients; top-line data expected mid-2025.","US real-world data: 2M diagnosed HS patients; market opportunity >$10B by 2035; low biologic penetration ~3%.","Four additional clinical trials imminent in new indications (palmo-plantar pustulosis, juvenile HS, seronegative SpA)."],"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":1373663394.4073873,"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":248695,"accession_number":"0001821586-24-000007","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-02-29T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"MoonLake FY 2023 net loss $44.1M; cash $511M; sonelokimab Phase 3 prep advances","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Cash, cash equivalents and short-term marketable debt securities $511.0M at Dec 31, 2023, up from $496M at Sep 30, 2023.","Net loss for FY 2023 $44.1M, improved from $64.5M in FY 2022.","R&D expenses $31.8M in FY 2023, down from $42.0M in FY 2022.","Completed positive Phase 2 data for sonelokimab in HS and PsA; FDA/EMA feedback supports Phase 3 VELA program in HS.","Raised $85M gross proceeds from at-the-market offerings; cash runway expected to end of 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.73,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":"2023-FY","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":1373663394.4073873,"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":248694,"accession_number":"0001213900-24-016737","cik":1821586,"company_name":"MoonLake Immunotherapeutics","ticker":"MLTX","form_type":"8-K","filed_at":"2024-02-26T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"MoonLake gets FDA & EMA support for Phase 3 sonelokimab in hidradenitis suppurativa","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA and EMA both support Phase 3 design for sonelokimab (SLK) in HS; trial named VELA.","Phase 3 will enroll 800 patients; single 120mg dose vs placebo over 16 weeks; primary endpoint HiSCR75.","First patient randomization expected Q2 2024; primary endpoint readout mid-2025.","Combined Phase 2 and Phase 3 data to support BLA and EU marketing application.","End-of-Phase 2 meeting for PsA with FDA expected Q2 2024; Phase 3 start Q4 2024."],"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":1373663394.4073873,"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}