{"filings":[{"id":93912,"accession_number":"0001104659-26-055242","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2026-05-05T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q1 net loss $53.5M ($0.85/share); AMT-130 UK MAA on track for Q3","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $53.5M vs $43.6M YoY; revenue $3.6M up from $1.6M on license revenue.","Cash $586.6M; runway into H2 2029; R&D down 19% to $29.2M, SG&A up 84% to $20.1M.","FDA Type B meeting scheduled Q2 2026 for AMT-130; UK MAA submission expected Q3 2026.","AMT-260 cohort 2 enrollment on track mid-2026; data from first cohort at June 2026 conference.","AMT-191 dosing paused at mid/high dose due to liver enzyme DLTs; all 11 patients off ERT."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.85,"consensus_revenue_estimate":null,"consensus_revenue_actual":3562000.0,"consensus_period":"2026-Q1","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1557607545.9960268,"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":93911,"accession_number":"0001104659-26-052112","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2026-04-30T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.","Expected MAA submission in Q3 2026 based on Phase I/II three-year data showing 75% slowing of disease progression at high dose.","FDA Type B meeting granted in Q2 2026 to discuss potential Phase III design and four-year analysis plan.","Actively pursuing additional ex-US regulatory pathways for AMT-130; updates expected H2 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":0.6,"calibrated_materiality_score":0.6,"market_cap_usd":1557607545.9960268,"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":105907,"accession_number":"0001104659-26-021890","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2026-03-02T23:59:59+00:00","items":["2.02","7.01","9.01"],"status":"ready","headline":"FDA rejects AMT-130 Phase I/II data as sufficient for approval; recommends randomized sham-controlled study","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.","Cash and investments $622.5M, expected to fund operations into H2 2029.","FDA stated Phase I/II data vs external control insufficient for marketing application; strongly recommends prospective, randomized, double-blind, sham surgery-controlled study.","Company plans to request Type B meeting in Q2 2026 to discuss Phase III study design.","AMT-260 MTLE Phase I/IIa enrollment completed in first cohort; data expected H1 2026."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":1.0,"calibrated_materiality_score":1.0,"market_cap_usd":1557607545.9960268,"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":105906,"accession_number":"0001104659-26-003075","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2026-01-13T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure updates corporate presentation; no specific new details disclosed in limited filing text","summary_kind":"llm","event_type":"other_material","confidence":"low","bullets":["Company furnished an updated corporate presentation as Exhibit 99.1.","Full presentation content not included in the filing; only cover and disclaimer visible.","Material changes, if any, cannot be determined from the provided exhibit text.","Filing is a routine Regulation FD disclosure with no new financial or strategic events stated."],"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":1557607545.9960268,"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":105905,"accession_number":"0001104659-26-002317","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2026-01-09T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure schedules Type A FDA meeting for accelerated approval of AMT-130 in Huntington's disease","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Type A meeting with FDA scheduled to discuss BLA data package for accelerated approval of AMT-130 (Huntington's disease gene therapy).","CEO Matt Kapusta emphasized commitment to constructive dialogue and timely resolution for patients with high unmet need.","Regulatory update expected after receipt of official meeting minutes from the FDA."],"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":1557607545.9960268,"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":122169,"accession_number":"0001104659-25-118292","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-12-04T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA says uniQure's AMT-130 Phase I/II data unlikely to support BLA submission","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA final meeting minutes from Oct 29 pre-BLA meeting: Phase I/II data for AMT-130 unlikely to support BLA submission.","uniQure plans to request follow-up FDA meeting in Q1 2026 to discuss path forward.","AMT-130 targets Huntington's disease; company evaluating FDA feedback.","CEO Matt Kapusta reaffirms commitment to advancing AMT-130."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":1557607545.9960268,"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":122168,"accession_number":"0001104659-25-108802","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-11-10T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q3 net loss $80.5M; FDA creates uncertainty for AMT-130 BLA","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss of $80.5M ($1.38 loss per share) vs $44.4M loss in Q3 2024; revenue $3.7M (+$1.4M YoY).","Cash, cash equivalents and investments $694.2M as of Sept 30, 2025; raised ~$323.7M net from public offering.","AMT-130 Phase I/II topline: 75% slowing in cUHDRS (p=0.003), 60% in TFC (p=0.033) at 36 months vs external control.","Pre-BLA meeting with FDA: FDA no longer agrees Phase I/II data vs external control may support BLA; submission timing unclear.","R&D expenses $34.4M (+$3.8M YoY) driven by $6.6M in BLA preparation; SG&A $19.4M (+$7.8M YoY)."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.9,"consensus_revenue_estimate":null,"consensus_revenue_actual":10530000.0,"consensus_period":"2025-Q3","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1557607545.9960268,"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":122167,"accession_number":"0001104659-25-105223","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-11-03T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"FDA no longer considers AMT-130 Phase I/II vs external control adequate for BLA","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["Pre-BLA meeting feedback: FDA believes data from Phase I/II of AMT-130 vs external control may not serve as primary evidence for BLA.","This reverses prior FDA guidance from multiple Type B meetings over past year and Breakthrough Therapy designation in April 2025.","BLA submission timing for AMT-130 in Huntington's disease is now unclear.","Company expects final meeting minutes within 30 days and plans to urgently engage FDA.","uniQure also plans to pursue parallel discussions with EU and UK regulators."],"consensus_eps_estimate":null,"consensus_eps_actual":null,"consensus_revenue_estimate":null,"consensus_revenue_actual":null,"consensus_period":null,"consensus_source":null,"sentiment":"negative","materiality_score":0.9,"calibrated_materiality_score":0.9,"market_cap_usd":1557607545.9960268,"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":138898,"accession_number":"0001104659-25-094011","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-09-29T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"uniQure prices upsized $300M public offering of ordinary shares and pre-funded warrants","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Pricing of 5,789,473 shares at $47.50/share plus pre-funded warrants for 526,316 shares.","Underwriters' option exercised in full for 947,368 additional shares; total gross proceeds ~$300M.","Net proceeds estimated at ~$323.75M after underwriting discounts and expenses.","Closing expected on or about September 29, 2025.","Leerink Partners, Stifel, Guggenheim Securities, Van Lanschot Kempen act as bookrunners."],"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":1557607545.9960268,"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":138897,"accession_number":"0001104659-25-092750","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-09-24T23:59:59+00:00","items":["1.01","2.03","9.01"],"status":"ready","headline":"uniQure secures $175M loan facility from Hercules Capital; draws $50M to refinance debt","summary_kind":"llm","event_type":"debt","confidence":"high","bullets":["$175M 2025 Term Loan from Hercules Capital; $50M drawn on Sept 22, 2025 to refinance existing $50M outstanding.","Additional $100M available upon raising >$150M and BLA approval for AMT-130 by mid-2027; another $25M subject to Hercules committee approval.","Interest rate at greater of 9.45% or prime+2.45%; maturity Oct 1, 2030; amortization starts Oct 2028 (or Oct 2029 if milestone met).","Prepayment penalty 1.50% within first 30 months, 0.75% thereafter.","No amortization if revenue targets for AMT-130 met before Dec 31, 2028."],"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":1557607545.9960268,"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":138896,"accession_number":"0001104659-25-092740","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-09-24T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"uniQure AMT-130 Phase I/II meets primary endpoint: 75% HD progression slowing at 36 months","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["High-dose AMT-130 showed 75% slowing on cUHDRS (p=0.003) vs external control; key secondary TFC endpoint also met (60% slowing, p=0.033).","Mean CSF NfL reduced 8.2% from baseline at 36 months, supporting potential disease modification.","No new drug-related serious adverse events since Dec 2022; manageable safety profile.","Company plans pre-BLA meeting with FDA later 2025, BLA submission targeted for Q1 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":0.95,"calibrated_materiality_score":0.95,"market_cap_usd":1557607545.9960268,"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":138895,"accession_number":"0001558370-25-009692","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-07-29T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure reports Q2 loss of $37.7M; FDA agrees on AMT-130 BLA pathway for Q1 2026 submission","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Revenue $5.3M, down from $11.1M YoY; net loss $37.7M ($0.69/share).","FDA alignment on SAP and CMC for AMT-130 BLA; topline three-year data in Sept 2025.","AMT-260 first patient showed 92% seizure reduction at 5 months with no serious AEs.","Cash $377M expected to fund operations into H2 2027.","Appointed Kylie O’Keefe as Chief Customer and Strategy Officer."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.49,"consensus_revenue_estimate":null,"consensus_revenue_actual":6829000.0,"consensus_period":"2025-Q2","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1557607545.9960268,"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":138894,"accession_number":"0001104659-25-071441","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-07-29T23:59:59+00:00","items":["1.01","9.01"],"status":"ready","headline":"uniQure enters $200M ATM equity offering agreement with Leerink Partners","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Entered Sales Agreement with Leerink Partners for at-the-market offering of up to $200M of ordinary shares.","Leerink to receive commission of up to 3.0% of gross proceeds from sales as agent.","Sales may be made on Nasdaq or other U.S. trading markets; no obligation to sell shares.","ATM program effective immediately; terminates upon sale of all shares or agreement termination."],"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":1557607545.9960268,"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":156375,"accession_number":"0001558370-25-008627","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-06-13T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"uniQure shareholders approve 2.4M share increase to 2014 incentive plan","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Shareholders approved amendment to the 2014 Share Incentive Plan to increase shares reserved by 2,400,000.","Reappointed executive director Matthew Kapusta and non-executive directors Robert Gut and Jeremy Springhorn.","Appointed KPMG Accountants N.V. as external auditor for fiscal year 2025.","Advisory say-on-pay resolution passed with ~87% of votes cast in favor.","All 11 proposals on the agenda were approved by shareholders."],"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":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":1557607545.9960268,"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":156374,"accession_number":"0001104659-25-055242","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-06-02T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure reaches FDA alignment on AMT-130 BLA for Huntington's disease; submission by Q1 2026","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA supports cUHDRS as accelerated approval endpoint; primary analysis uses 3-year cUHDRS change vs propensity score-weighted ENROLL-HD external control.","CMC validation: FDA agrees to use prior HEMGENIX knowledge, plus additional AMT-130 GMP batches and one PPQ batch; potency assay plan accepted pending qualification.","BLA submission targeting Q1 2026 with request for priority review; pre-BLA meeting in Q4 2025; Phase I/II topline data in Q3 2025.","Type B meetings held in Q1 and Q2 2025 on CMC and SAP; FDA aligned on statistical analysis plan including sensitivity analyses using TRACK-HD and PREDICT-HD datasets."],"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":1557607545.9960268,"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":156373,"accession_number":"0001558370-25-007065","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-05-09T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q1 net loss per share $0.82; AMT-130 granted FDA Breakthrough Therapy designation","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $43.6M ($0.82 per share) vs $65.6M ($1.36) in Q1 2024; revenue down to $1.6M from $8.5M.","Cash and investments $409M as of Mar 31, 2025; expects funding into H2 2027.","AMT-130 for Huntington's disease granted FDA Breakthrough Therapy designation in Apr 2025.","BLA submission guidance for AMT-130 expected in Q2 2025 after official meeting minutes.","Initial AMT-260 epilepsy data to be presented May 29, 2025; AMT-191 Fabry data in H2 2025."],"consensus_eps_estimate":null,"consensus_eps_actual":-0.82,"consensus_revenue_estimate":null,"consensus_revenue_actual":1567000.0,"consensus_period":"2025-Q1","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.75,"calibrated_materiality_score":0.75,"market_cap_usd":1557607545.9960268,"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":156372,"accession_number":"0001558370-25-004867","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-04-16T23:59:59+00:00","items":["5.02","9.01"],"status":"ready","headline":"uniQure amends CEO Matthew Kapusta's employment agreement; base salary $676,700, 60% target bonus","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Annual base salary set at $676,700, subject to review; target annual bonus 60% of base salary.","Eligible for long-term cash or equity incentives under 2014 Share Incentive Plan at Board discretion.","Severance without cause/good reason: 18 months base salary, COBRA, pro-rata bonus, 1.5x target bonus, equity acceleration.","Change-in-control termination: lump sum 2x salary + 2x target bonus, COBRA, pro-rata bonus, equity acceleration.","Subject to confidentiality, non-competition, non-solicitation, and mutual non-disparagement covenants."],"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":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":1557607545.9960268,"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":174813,"accession_number":"0001558370-25-001693","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-02-27T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure secures FDA Accelerated Approval pathway for AMT-130; 2024 net loss $239.6M","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["FDA agreed data from Phase I/II AMT-130 studies vs external control may support BLA; cUHDRS as intermediate endpoint, NfL as supportive.","Cash and equivalents $367.5M at Dec 31, 2024; plus $80.7M net from public offering, funds operations into H2 2027.","Net loss $239.6M ($4.92 loss per share) for 2024, vs $308.5M loss in 2023; revenues $27.1M up from $15.8M.","Completed enrollment in third cohort of AMT-130 Phase I/II; initial safety update expected Q2 2025.","Restructuring and sale of Lexington facility reduced workforce by ~65%, cut cash burn ~$70M/year."],"consensus_eps_estimate":null,"consensus_eps_actual":-4.92,"consensus_revenue_estimate":null,"consensus_revenue_actual":27119000.0,"consensus_period":"2024-FY","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1557607545.9960268,"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":174812,"accession_number":"0001104659-25-002043","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2025-01-08T23:59:59+00:00","items":["1.01","8.01","9.01"],"status":"ready","headline":"uniQure prices $75M public offering of 4.4M shares at $17.00 per share","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Offering of 4,411,764 ordinary shares at $17.00/share; expected gross proceeds ~$75M.","Net proceeds estimated at ~$70.1M (~$80.7M if underwriters exercise 30-day overallotment of 661,764 shares).","Leerink Partners, Stifel, and Guggenheim Securities act as bookrunning managers.","Closing expected on or about January 10, 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":"negative","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1557607545.9960268,"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":191763,"accession_number":"0001558370-24-016106","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-12-10T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure reaches FDA alignment on Accelerated Approval pathway for AMT-130 in Huntington's disease","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA agrees data from ongoing Phase I/II studies vs natural history external control may serve as primary basis for BLA under Accelerated Approval.","FDA agrees cUHDRS may serve as intermediate clinical endpoint; reductions in CSF NfL provide supportive evidence of benefit.","Company initiated BLA readiness activities; plans to discuss statistical analysis plan and CMC requirements with FDA in H1 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":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":1557607545.9960268,"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":191762,"accession_number":"0001558370-24-015883","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-11-21T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure doses first patient in Phase I/IIa trial of AMT-260 for refractory temporal lobe epilepsy","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First patient dosed in GenTLE Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy (MTLE).","AMT-260 uses AAV9 vector to deliver miRNAs that reduce GluK2 protein subunit expression, targeting seizure triggers.","Trial includes two dose cohorts of six patients each across 10 U.S. sites; two more sites expected by end of 2024.","CMO Walid Abi-Saab notes 1/3 of focal seizure patients lack effective treatment, highlighting potential for AMT-260.","Preclinical studies showed dose-dependent seizure reduction; program updates expected in 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":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":1557607545.9960268,"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":191761,"accession_number":"0001558370-24-014334","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-11-05T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q3 net loss $44.4M; cash runway through 2027; FDA meeting for Huntington gene therapy","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $44.4M ($0.91/share) vs $89.6M ($1.88) in Q3 2023; revenue $2.3M (up from $1.4M).","Cash $435.2M as of Sep 30; retired $50M debt; expects cash runway through end of 2027.","Sold Lexington facility and restructured, cutting ~65% of roles (300) and reducing cash burn by $70M/year.","Type B FDA meeting scheduled late Nov 2024 to discuss accelerated pathway for AMT-130 in Huntington's disease.","Positive interim data at 24 months: AMT-130 high dose showed significant slowing of disease progression (p=0.007) and NfL reduction (p=0.02)."],"consensus_eps_estimate":null,"consensus_eps_actual":-3.42,"consensus_revenue_estimate":null,"consensus_revenue_actual":21898000.0,"consensus_period":"2024-Q3","consensus_source":"xbrl_only","sentiment":"positive","materiality_score":0.8,"calibrated_materiality_score":0.8,"market_cap_usd":1557607545.9960268,"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":191760,"accession_number":"0001558370-24-013276","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-10-15T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure doses first patient in Phase I/II trial of AMT-162 gene therapy for SOD1-ALS","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First patient dosed in EPISOD1 Phase I/II open-label trial of AMT-162 for SOD1-ALS, a rare inherited progressive motor neuron disease.","Trial has three dose-escalating cohorts; up to four patients per cohort receiving intrathecal AMT-162 with immunosuppression.","AMT-162 is an AAVrh10-based gene therapy expressing miRNA to knock down mutated SOD1 protein; granted Orphan Drug and Fast Track FDA designations.","Four active U.S. sites; plans to activate seven additional sites by Q1 2025.","Trial will assess safety, tolerability, and exploratory efficacy via neurofilament light chain and SOD1 protein biomarkers."],"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":1557607545.9960268,"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":208240,"accession_number":"0001558370-24-012941","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-09-23T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure receives FDA Orphan Drug Designation for AMT-191 gene therapy for Fabry disease","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA granted Orphan Drug Designation to AMT-191 for Fabry disease on Sep 23, 2024.","AMT-191 is a one-time IV AAV5-based gene therapy delivering a GLA transgene.","First patient dosed in Aug 2024 in a U.S. multi-center open-label Phase I/IIa trial.","Designation provides tax credits, fee waivers, and 7-year US market exclusivity if approved.","Initial Phase I/IIa clinical data expected in 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":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1557607545.9960268,"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":208239,"accession_number":"0001558370-24-012295","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-08-15T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure doses first patient in Phase I/IIa AMT-191 Fabry disease trial","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["First patient dosed in open-label, two-cohort Phase I/IIa trial of AMT-191 gene therapy for Fabry disease.","Low-dose cohort: 6e10^13 gc/kg; high-dose: 3e10^14 gc/kg; one-time IV infusion; 24-month follow-up.","AMT-191 uses same AAV5 delivery as HEMGENIX; targets liver to produce GLA protein.","CEO cites catalysts: FDA engagement for AMT-130 (Huntington's), new trials in epilepsy and SOD1-ALS.","Cash runway extended through end of 2027 from cost reduction initiatives."],"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":1557607545.9960268,"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":208238,"accession_number":"0001558370-24-010529","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-08-01T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q2 net loss $56.3M; restructures to cut 65% of workforce, burn by $75M/yr","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $56.3M ($1.16 EPS) vs $68.5M ($1.44 EPS) in Q2 2023; revenue $11.1M up from $2.4M.","Restructuring: 65% headcount reduction (~300 roles), sale of Lexington facility, $75M annual cash burn cut including $50M debt retirement.","Cash $524M as of June 30, expected to fund operations through end 2027.","FDA granted RMAT designation for AMT-130 in Huntington's; interim data showed dose-dependent slowing of disease progression and reduced NfL.","Patient screening started for three new Phase I/II trials (AMT-260 mTLE, AMT-191 Fabry, AMT-162 SOD1 ALS); enrollment expected Q3 2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-2.51,"consensus_revenue_estimate":null,"consensus_revenue_actual":19611000.0,"consensus_period":"2024-Q2","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.85,"calibrated_materiality_score":0.85,"market_cap_usd":1557607545.9960268,"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":208237,"accession_number":"0001558370-24-009957","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-07-23T23:59:59+00:00","items":["1.01","2.01","5.02","7.01","9.01"],"status":"ready","headline":"uniQure closes sale of Lexington facility to Genezen for $25M; $40M annual cash burn savings","summary_kind":"llm","event_type":"m_and_a","confidence":"high","bullets":["Sold Lexington, MA manufacturing facility to Genezen for $12.5M in Series C stock and $12.5M convertible note (total $25M).","Prepaid $50M of $100M Hercules debt; remaining $50M matures Jan 2027; expects $40M annual reduction in cash burn.","COO Pierre Caloz exits as role eliminated; Amin Abujoub appointed Chief Technical Operations Officer.","CEO Matt Kapusta joins Genezen board; Genezen to supply HEMGENIX under commercial supply agreement.","Transaction closed July 22, 2024; uniQure becomes meaningful shareholder in Genezen."],"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":1557607545.9960268,"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":208236,"accession_number":"0001558370-24-009696","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-07-09T23:59:59+00:00","items":["7.01","8.01","9.01"],"status":"ready","headline":"uniQure announces positive interim Phase I/II data for AMT-130: 80% slowing of Huntington's progression at high dose","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["High-dose AMT-130 showed 80% slowing of cUHDRS decline vs. external control at 24 months (p=0.007).","CSF neurofilament light chain reduced 11% from baseline at 24 months in treated patients (p=0.02).","AMT-130 received first-ever RMAT designation for Huntington's disease from FDA.","Company expects to meet with FDA in H2 2024 to discuss expedited development and accelerated approval.","No new AMT-130-related serious adverse events; safety profile manageable at both doses."],"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":1557607545.9960268,"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":208235,"accession_number":"0001104659-24-076568","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-07-01T23:59:59+00:00","items":["1.01","7.01","9.01"],"status":"ready","headline":"uniQure sells Lexington manufacturing facility to Genezen for $25M, reduces cash burn $40M/year","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Consideration $25M: $12.5M of Series C preferred stock and $12.5M convertible note (8%, 63-month maturity).","Genezen to manufacture HEMGENIX commercial supply; CEO Matt Kapusta joins Genezen board after close.","Company expects to reduce annual cash burn by ~$40M and repay $50M debt, saving interest expense.","Majority of Lexington employees offered jobs at Genezen; transaction expected to close early Q3 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":1557607545.9960268,"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":225836,"accession_number":"0001558370-24-009305","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-06-20T23:59:59+00:00","items":["5.02","5.07","9.01"],"status":"ready","headline":"UniQure shareholders approve share plan amendment and reappoint directors","summary_kind":"llm","event_type":"other_material","confidence":"high","bullets":["Shareholders approved an amendment to the 2014 Share Incentive Plan, increasing reserved shares by 1,500,000 to a total of 2,615,146.","All 10 proposals passed, including reappointment of non-executive directors Rachelle Jacques and David Meek.","KPMG Accountants N.V. appointed as external auditor for the 2024 financial year.","Approximately 32.7 million shares voted (~67% of 48.5 million entitled); advisory say-on-pay approved."],"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":0.4,"calibrated_materiality_score":0.4,"market_cap_usd":1557607545.9960268,"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":225835,"accession_number":"0001558370-24-008845","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-06-03T23:59:59+00:00","items":["7.01","9.01"],"status":"ready","headline":"uniQure receives FDA RMAT designation for gene therapy AMT-130 in Huntington's disease","summary_kind":"llm","event_type":"regulatory","confidence":"high","bullets":["FDA granted RMAT designation for AMT-130 based on 24-month Phase I/II data vs. natural history cohort.","First RMAT designation ever for a Huntington's disease therapy, enabling fast track and breakthrough therapy benefits.","Designation allows increased collaboration with FDA on accelerated approval pathways and expedited development.","uniQure expects to provide updated interim data from Phase I/II studies in mid-2024, including up to 3-year follow-up on 29 patients."],"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":1557607545.9960268,"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":225834,"accession_number":"0001558370-24-006916","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-05-07T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure Q1 net loss narrows to $65.6M; cash $555.7M; advancing AMT-130 regulatory path","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $65.6M ($1.36/sh) vs $77.2M ($1.63) in Q1 2023; revenue $8.5M vs $5.3M.","Cash $555.7M (down from $617.9M Dec 2023); expects to fund operations into Q2 2027.","On track for FDA interaction for AMT-130 in Q2 2024; clinical update mid-2024 with up to 3-year data on 29 patients.","New Phase I/II trials: Fabry disease (AMT-191) enrollment begins Q2 2024; SOD1-ALS and MTLE expected Q3 2024.","Comprehensive operational review to reduce expenses underway, completion expected mid-2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-1.36,"consensus_revenue_estimate":null,"consensus_revenue_actual":8485000.0,"consensus_period":"2024-Q1","consensus_source":"xbrl_only","sentiment":"neutral","materiality_score":0.65,"calibrated_materiality_score":0.65,"market_cap_usd":1557607545.9960268,"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":225833,"accession_number":"0001558370-24-004994","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-04-12T23:59:59+00:00","items":["5.02"],"status":"ready","headline":"Non-executive director Paula Soteropoulos not standing for re-election at uniQure's 2024 annual meeting","summary_kind":"llm","event_type":"leadership","confidence":"high","bullets":["Paula Soteropoulos notified the Board on April 9, 2024, that she will not stand for re-election.","Her current term expires at the 2024 annual meeting of shareholders.","Decision not due to any disagreement with the Company, management, Board, or committees.","No replacement named; the Board will proceed with the annual meeting election process."],"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":1557607545.9960268,"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":244945,"accession_number":"0001104659-24-028484","cik":1590560,"company_name":"uniQure N.V.","ticker":"QURE","form_type":"8-K","filed_at":"2024-02-28T23:59:59+00:00","items":["2.02","9.01"],"status":"ready","headline":"uniQure reports $308.5M net loss in FY2023; cash $617.9M; pipeline programs advancing","summary_kind":"llm","event_type":"earnings","confidence":"high","bullets":["Net loss $308.5M ($6.47 per share) vs $126.8M ($2.71) in FY2022; revenue $15.8M vs $106.5M.","Cash and investments $617.9M as of Dec 31, 2023; expects to fund operations into Q2 2027.","Strategic reorganization expected to deliver $180M in cost savings over three years.","FDA clearance received for IND applications for AMT-260 (mTLE) and AMT-191 (Fabry); enrollment in Phase I/II trials expected H1 2024.","Regulatory interactions for AMT-130 (Huntington's) approval pathway expected in 2024; interim data update in mid-2024."],"consensus_eps_estimate":null,"consensus_eps_actual":-6.47,"consensus_revenue_estimate":null,"consensus_revenue_actual":15843000.0,"consensus_period":"2023-FY","consensus_source":"xbrl_only","sentiment":"negative","materiality_score":0.7,"calibrated_materiality_score":0.7,"market_cap_usd":1557607545.9960268,"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}