Highest-materiality recent filing
uniQure Q1 net loss $53.5M ($0.85/share); AMT-130 UK MAA on track for Q3
Net loss of $53.5M vs $43.6M YoY; revenue $3.6M up from $1.6M on license revenue.
uniQure plans UK MAA submission for AMT-130 in Q3 2026 after successful MHRA meeting
Successful MHRA pre-submission meeting for AMT-130 gene therapy in Huntington's disease.
Net loss of $199.0M for 2025 vs $239.6M in 2024; revenue $16.1M down 41% YoY.
uniQure updates corporate presentation; no specific new details disclosed in limited filing text
Company furnished an updated corporate presentation as Exhibit 99.1.
uniQure schedules Type A FDA meeting for accelerated approval of AMT-130 in Huntington's disease
Type A meeting with FDA scheduled to discuss BLA data package for accelerated approval of AMT-130 (Huntington's disease gene therapy).
FDA says uniQure's AMT-130 Phase I/II data unlikely to support BLA submission
FDA final meeting minutes from Oct 29 pre-BLA meeting: Phase I/II data for AMT-130 unlikely to support BLA submission.
uniQure Q3 net loss $80.5M; FDA creates uncertainty for AMT-130 BLA
Net loss of $80.5M ($1.38 loss per share) vs $44.4M loss in Q3 2024; revenue $3.7M (+$1.4M YoY).
FDA no longer considers AMT-130 Phase I/II vs external control adequate for BLA
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.
uniQure prices upsized $300M public offering of ordinary shares and pre-funded warrants
Pricing of 5,789,473 shares at $47.50/share plus pre-funded warrants for 526,316 shares.
uniQure AMT-130 Phase I/II meets primary endpoint: 75% HD progression slowing at 36 months
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).
uniQure secures $175M loan facility from Hercules Capital; draws $50M to refinance debt
$175M 2025 Term Loan from Hercules Capital; $50M drawn on Sept 22, 2025 to refinance existing $50M outstanding.
uniQure enters $200M ATM equity offering agreement with Leerink Partners
Entered Sales Agreement with Leerink Partners for at-the-market offering of up to $200M of ordinary shares.
uniQure reports Q2 loss of $37.7M; FDA agrees on AMT-130 BLA pathway for Q1 2026 submission
Revenue $5.3M, down from $11.1M YoY; net loss $37.7M ($0.69/share).
uniQure shareholders approve 2.4M share increase to 2014 incentive plan
Shareholders approved amendment to the 2014 Share Incentive Plan to increase shares reserved by 2,400,000.
uniQure reaches FDA alignment on AMT-130 BLA for Huntington's disease; submission by Q1 2026
FDA supports cUHDRS as accelerated approval endpoint; primary analysis uses 3-year cUHDRS change vs propensity score-weighted ENROLL-HD external control.
uniQure Q1 net loss per share $0.82; AMT-130 granted FDA Breakthrough Therapy designation
Net loss $43.6M ($0.82 per share) vs $65.6M ($1.36) in Q1 2024; revenue down to $1.6M from $8.5M.
uniQure amends CEO Matthew Kapusta's employment agreement; base salary $676,700, 60% target bonus
Annual base salary set at $676,700, subject to review; target annual bonus 60% of base salary.
uniQure secures FDA Accelerated Approval pathway for AMT-130; 2024 net loss $239.6M
FDA agreed data from Phase I/II AMT-130 studies vs external control may support BLA; cUHDRS as intermediate endpoint, NfL as supportive.
uniQure prices $75M public offering of 4.4M shares at $17.00 per share
Offering of 4,411,764 ordinary shares at $17.00/share; expected gross proceeds ~$75M.
uniQure reaches FDA alignment on Accelerated Approval pathway for AMT-130 in Huntington's disease
FDA agrees data from ongoing Phase I/II studies vs natural history external control may serve as primary basis for BLA under Accelerated Approval.
uniQure doses first patient in Phase I/IIa trial of AMT-260 for refractory temporal lobe epilepsy
First patient dosed in GenTLE Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy (MTLE).
uniQure Q3 net loss $44.4M; cash runway through 2027; FDA meeting for Huntington gene therapy
Net loss $44.4M ($0.91/share) vs $89.6M ($1.88) in Q3 2023; revenue $2.3M (up from $1.4M).
uniQure doses first patient in Phase I/II trial of AMT-162 gene therapy for SOD1-ALS
First patient dosed in EPISOD1 Phase I/II open-label trial of AMT-162 for SOD1-ALS, a rare inherited progressive motor neuron disease.
uniQure receives FDA Orphan Drug Designation for AMT-191 gene therapy for Fabry disease
FDA granted Orphan Drug Designation to AMT-191 for Fabry disease on Sep 23, 2024.
uniQure doses first patient in Phase I/IIa AMT-191 Fabry disease trial
First patient dosed in open-label, two-cohort Phase I/IIa trial of AMT-191 gene therapy for Fabry disease.
uniQure Q2 net loss $56.3M; restructures to cut 65% of workforce, burn by $75M/yr
Net loss $56.3M ($1.16 EPS) vs $68.5M ($1.44 EPS) in Q2 2023; revenue $11.1M up from $2.4M.
uniQure closes sale of Lexington facility to Genezen for $25M; $40M annual cash burn savings
Sold Lexington, MA manufacturing facility to Genezen for $12.5M in Series C stock and $12.5M convertible note (total $25M).
High-dose AMT-130 showed 80% slowing of cUHDRS decline vs. external control at 24 months (p=0.007).
uniQure sells Lexington manufacturing facility to Genezen for $25M, reduces cash burn $40M/year
Consideration $25M: $12.5M of Series C preferred stock and $12.5M convertible note (8%, 63-month maturity).
UniQure shareholders approve share plan amendment and reappoint directors
Shareholders approved an amendment to the 2014 Share Incentive Plan, increasing reserved shares by 1,500,000 to a total of 2,615,146.
uniQure receives FDA RMAT designation for gene therapy AMT-130 in Huntington's disease
FDA granted RMAT designation for AMT-130 based on 24-month Phase I/II data vs. natural history cohort.
uniQure Q1 net loss narrows to $65.6M; cash $555.7M; advancing AMT-130 regulatory path
Net loss $65.6M ($1.36/sh) vs $77.2M ($1.63) in Q1 2023; revenue $8.5M vs $5.3M.
Paula Soteropoulos notified the Board on April 9, 2024, that she will not stand for re-election.
uniQure reports $308.5M net loss in FY2023; cash $617.9M; pipeline programs advancing
Net loss $308.5M ($6.47 per share) vs $126.8M ($2.71) in FY2022; revenue $15.8M vs $106.5M.
In connection with the closing of the Lexington Transaction, on July 22, 2024, the Company notified Pierre Caloz, the Company’s Chief Operating Officer, that his employment was being terminated consistent with the terms of the employment agreement by and between uniQure biopharma B.V. and Mr. Caloz, dated May 17, 2021.
On April 9, 2024, Paula Soteropoulos notified the board of directors (the “ Board ”) of uniQure N.V. (the “ Company ”) that she will not stand for re-election as a non-executive director when her current term expires at Company’s 2024 annual meeting of shareholders.
Max materiality 1.00 · Median 0.75 · Most common event other_material