Welcome to our dedicated page for Uniqure news (Ticker: QURE), a resource for investors and traders seeking the latest updates and insights on Uniqure stock.
uniQure N.V. reports company news on its gene therapy pipeline, regulatory interactions, clinical data, operating results, and capital structure. The company develops genetic medicines for severe diseases, with disclosed programs including AMT-130 for Huntington’s disease, AMT-260 for refractory mesial temporal lobe epilepsy, AMT-191 for Fabry disease, ALS programs, and an approved gene therapy for hemophilia B.
Recurring updates cover FDA and MHRA discussions, clinical-trial observations, exploratory efficacy and safety data, quarterly and annual financial results, debt financing arrangements, corporate presentations, and governance or shareholder matters tied to its Nasdaq-listed public-company status.
uniQure (NASDAQ: QURE) reported second quarter 2026 results and pipeline progress, highlighted by U.S. and U.K. regulatory paths for AMT-130 in Huntington’s disease. Following a June Type B FDA meeting, the agency agreed that an accelerated approval BLA based on existing data is reasonable, and discussions on the confirmatory study design are underway, with BLA submission targeted for the third quarter of 2026 and four-year Phase I/II data expected in September 2026.
The company reported early Phase I/IIa AMT-260 data in refractory mesial temporal lobe epilepsy, with three of six low-dose patients achieving 79%-100% reductions in disabling seizures and no treatment-related SAEs. AMT-191 Fabry data showed substantial, dose-dependent α-Gal A elevations, stable lyso-Gb3, withdrawal from ERT in all 11 dosed patients and manageable safety, though mid- and high-dose dosing remains paused for liver enzyme DLT evaluation. uniQure closed a $259 million follow-on offering, boosting cash, equivalents and current investments to $810.3 million and extending its projected cash runway into 2030. Q2 2026 revenue was $5.8 million and net loss widened to $81.1 million.
uniQure (NASDAQ: QURE) will release its second quarter 2026 financial results before the U.S. market opens on Wednesday, July 29, 2026. Management will host an earnings conference call the same day at 8:30 a.m. ET, with a live webcast available in the Events & Presentations section of the company’s website.
A replay of the webcast will be archived for 90 days. Analysts can join the Q&A session by dialing (646) 307-1963 or toll-free (800) 715-9871 and entering conference ID 5075555, and are advised to connect 15 minutes before the start time.
uniQure (Nasdaq: QURE) closed its upsized underwritten public offering of 5,686,813 ordinary shares at $45.50 per share, including full exercise of the underwriters’ option for 741,758 additional shares, raising approximately $259 million in gross proceeds.
Net proceeds will support AMT-130 commercialization readiness, a confirmatory study, other clinical programs, business development and general corporate purposes.
uniQure (Nasdaq:QURE) priced an upsized underwritten public offering of 4,945,055 ordinary shares at $45.50 per share, targeting approximately $225 million in gross proceeds before fees.
The company granted underwriters a 30-day option for up to 741,758 additional shares, with closing expected on or about June 25, 2026, subject to customary conditions.
uniQure (Nasdaq: QURE) commenced a proposed $150 million underwritten public offering of ordinary shares and, for certain investors, pre-funded warrants. All securities are offered by the company, with a planned 30-day option for underwriters to buy up to an additional $22.5 million in shares.
The deal is subject to market conditions and may not be completed. Leerink Partners and Stifel are bookrunning managers, and the offering uses uniQure’s effective shelf registration on Form S-3 filed in January 2025.
uniQure (NASDAQ: QURE) reported preliminary six-month data from the first, low-dose cohort in its Phase I/IIa trial of AMT-260 for refractory mesial temporal lobe epilepsy.
Three of six patients had 79%–100% reductions in disabling seizures; safety showed no related serious adverse events and only mild to moderate side effects.
Enrollment continues in a higher-dose cohort, with updated results expected in the first half of 2027.
uniQure (NASDAQ: QURE) announced that the FDA indicated the ~3-year analysis from its Phase I/II study of AMT-130 in Huntington’s disease can serve as the primary basis for a BLA for accelerated approval. uniQure plans to submit the BLA in the third quarter of 2026.
The FDA aims to align in advance on the required confirmatory study design, potentially using concurrent control on standard-of-care therapy instead of a sham procedure, and has said it will work expeditiously. AMT-130 holds RMAT, Breakthrough Therapy, and Fast Track designations.
uniQure (NASDAQ: QURE) reported Q1 2026 results and program updates on May 5, 2026. Key items: a Type B FDA meeting is scheduled to discuss AMT-130 trial design; a UK MAA for AMT-130 is expected in Q3 2026. AMT-260 Phase I/IIa enrollment continues; first-cohort data due June 18-19, 2026. AMT-191 showed durable increases in α-Gal A and all 11 dosed patients stopped enzyme replacement therapy. AMT-162 development discontinued. Cash totaled $586.6M, runway into H2 2029; Q1 revenue $3.6M; net loss $53.5M (EPS -$0.85).
uniQure (NASDAQ: QURE) held a Pre-Submission meeting with the UK MHRA and expects to file a Marketing Authorization Application (MAA) for AMT-130 in Huntington’s disease in Q3 2026. The planned MAA will rely on three-year Phase I/II data showing a 75% slowing of disease progression at the high dose (p=0.003) versus a propensity score-matched external control and a generally manageable safety profile. uniQure also secured a Type B meeting with the U.S. FDA in Q2 2026 to discuss potential Phase III design and the four-year analysis expected in Q3 2026, and is pursuing additional international regulatory pathways.
uniQure (NASDAQ: QURE) will report first quarter 2026 financial results before market open on Tuesday, May 5, 2026. Management will host a conference call at 8:30 a.m. ET the same day. The live webcast and a 90-day replay will be available in the Events & Presentations section of the company website.
Analysts may access the live call by dialing the provided numbers and entering conference ID 4607289. Participants are asked to join 15 minutes before start time.