Huntington's Disease Association Northern Ireland

18/06/2026

UniQure gets FDA green light to file for Huntingtons gene therapy approval

June 17, 2026
Dear Huntington’s Disease Community,
We are writing to share an important update from our recently held Type B meeting with the U.S. Food and Drug Administration (FDA) regarding AMT-130, uniQure’s investigational gene therapy candidate in Huntington's disease (HD).
On June 17, 2026, uniQure issued a press release to announce that the FDA communicated that the 3-year analysis from the ongoing Phase I/II study would be acceptable as the primary basis of a Biologics License Application (BLA) for the accelerated approval for AMT-130 in Huntington’s disease. The FDA seeks to align on the confirmatory study design prior to the BLA submission, including consideration of concurrent control on standard-of-care therapy instead of a sham procedure. The FDA communicated that they would work as expeditiously as possible with uniQure on this effort. uniQure is committed to conducting the confirmatory study without delay and expects to further align with the FDA on the details of such a study prior to BLA submission. uniQure intends to submit the BLA in the third quarter of 2026.
"Today's announcement reflects the outcome we have worked toward throughout our continued regulatory engagement with FDA, and we are deeply grateful for FDA’s genuine commitment to addressing the unmet need of Americans living with HD," said Matt Kapusta, chief executive officer at uniQure.
Our deepest gratitude goes to the patients, families, and advocacy partners who shared their experiences throughout this part of the process. Your voices were vital in keeping the patient perspective at the forefront of our recent regulatory discussions. Drug development is a long journey and often the path is unclear; however, your fortitude continues to inspire us. We remain focused on bringing AMT-130 to patients and families as quickly and responsibly as possible in the United States and globally.
uniQure will continue to keep you informed as additional updates become available. Thank you for your ongoing support and being an essential part of this journey.
If you have any questions, please email [email protected] or call 1-866-520-1257. Sincerely,
Daniel Leonard
Executive Director of Global Patient Advocacy
AMT-130 has not been approved by the US FDA, EMA, MHRA or any other regulatory body as safe and effective for any use

12/06/2026

Women’s Drop-in Group

The ONSIDE Women’s Group meets every Monday for a fun hour of crafts, chat, quizzes, discussion & trivia.

Please join us using the link below on Monday 15th June 2026 at 4.00pm.

Join Zoom Meeting

https://us06web.zoom.us/j/86161427622?pwd=44HEhuEgyzmH5598kYb0CrUYaztebf.1

Meeting ID: 861 6142 7622

Passcode: 602565



Men’s Drop-in Group



The OMG (Onside Men's) Group meet every Wednesday for an hour of chatting.

Please join us using the link below on Wednesday 17th June 2026 at 11:00am.

Join Zoom Meeting



https://us06web.zoom.us/j/82285570046?pwd=SExKREtVNG5hMnFJaWhPU3N5VzBsZz09



Meeting ID 822 8557 0046

Passcode 452226

12/06/2026

10,000 More Voices – My Experience of Using Equipment to Live Better with a Disability



We are inviting people from across Northern Ireland to share their experience of using HSC Trust provided equipment that helps them live better with a disability. Your story—positive, challenging or somewhere in between—will guide real improvements across Health and Social Care services.



This includes items that make daily life easier, such as:



• Wheelchairs • Electronic assistive technology
• Hospital beds • Community equipment
• Minor home adaptations • Homelifts



What is this survey about?

In 2024, the Department of Health (DoH) completed a regional review of Assistive Technology and Equipment Services (ATE). The review acknowledged many examples of good practice across the region in ensuring timely and effective provision. However, it also identified opportunities for improvement, particularly in relation to enhancing the experiences of service users.

In response, the Regional ATE Oversight Board commissioned a project through the 10,000 MORE Voices initiative to gain deeper insight into the experiences of service users, families and carers, and most importantly to identify actions that would improve the overall experience of accessing those HSC services.



Why your story matters

There is currently limited insight into what it is truly like to access Trust equipment services across Northern Ireland. The regional review identified strengths, but also opportunities to improve areas such as assessment, access, maintenance, communication and regional consistency.



By sharing your experience, you will help us to:

Understand what works well
Identify challenges and gaps
Highlight differences across Trusts
Support shared decision‑making
Strengthen person‑centred care
Influence improvements at service, organisation and regional levels


Your privacy

The information you share is private and confidential.

You do not need to give your name or any identifying details. Any personal information included in a story is removed before analysis. All data is handled in line with HSC Information Governance and GDPR requirements.


To complete online – please click here My Experience of Using Equipment to Live Better with a Disability survey - https://consultations2.nidirect.gov.uk/hsc/e65ac355/consultation/intro/

10/06/2026

Stress Control Classes running throughout June and July

Please find below and attached above information regarding Stress Control classes currently available. PHA would appreciate your support in promoting these free, online classes.

Funded by the Public Health Agency. Stress Control class topics covered include an overview of what stress is, controlling your thoughts and actions, and techniques to get a good night’s sleep. The classes are presented by Dr Jim White, a Clinical Psychologist, and are available at https://www.stresscontrolclass.com

The next block of classes are scheduled as follows:

• Session One: 9am Monday 8th June

• Session Two: 9am Monday 15th June

• Session Three: 9am Monday 22nd June

• Session Four: 9am Monday 29th June

• Session Five: 9am Monday 6th July

• Session Six: 9am Monday 13th July



Each session is available until 8am on the following Monday.

Participants do not have to register or log in to view the course – simply visit the website https://www.stresscontrolclass.com within the above timeframes and watch the streamed weekly sessions. Each class lasts around 90 minutes.

09/06/2026

Finding Your Way: What Help Is Available for Families Living with HD

Date: 11 June 2026
Time: 2:00pm - 3:00pm
Online.

Overview
An online session for those who want to learn more about how the Huntington’s Disease Association and other services can help you.

Living in a family where there is Huntington's disease can present many challenges and it can be difficult to know what support is available. Finding the right help at the right time can be daunting for those affected by Huntington's disease....and we're here to help.

Join us for a free online session led by Specialist Advisers from the Huntington's Disease Association. They will walk you through the support available, whatever your relationship to Huntington's disease and wherever you are on your journey.

We will be joined by our Ambassador Lauren, who will share her experience of supporting her husband Ian who was diagnosed with Huntington's three years ago. Ian cared for his mum as a teenager so he knows first-hand what the condition does as it develops. The condition affects how Ian thinks about things and his memory so Lauren has learnt to take that into account when talking to him.

Lauren said,
"Being a sole carer has been a huge learning curve! The Huntington's Disease Association has been absolutely amazing. Nothing is too much trouble, they have helped us every step of the way. We would be lost without them."
This session is open to everyone: family members, friends, health and social care professionals, and anyone who wants to know more. There will be plenty of time for questions.

https://www.eventbrite.co.uk/e/finding-your-way-what-help-is-available-for-families-living-with-hd-tickets-950621984947?aff=oddtdtcreator&_gl=1*1yu3efb*_up*MQ..*_ga*NjYwMjc0NjE2LjE3NzUxNDU0NTg.*_ga_TQVES5V6SH*czE3NzUxNDU0NTckbzEkZzEkdDE3NzUxNDU1MTQkajMkbDAkaDA.

08/06/2026

08/06/2026

Please find attached a copy of the Newry U3A timetable to begin in September.

Also included the dates for the registration event for those who they feel could benefit from joining. People can come to the registration days, as they will get a chance to talk to the volunteer tutors about the subjects they have an interest in.

They offer approximately 50 courses and activities, and also run one off events/sessions/trips throughout the academic year, so hopefully there is something for everyone.

They will be hosting an information stand at the MensFest day on 10th June in the leisure centre, Newry, and an information day in the Buttercrane on 13th August if you have an interest and maybe want to chat to find out more about them.

If people would like to call the Newry U3A office, they are open until 19th June 9.30am-12.30pm Monday to Friday. They close for approximately 7 weeks for summer break.