QURE Stock Just Shot Up 8% - uniQure’s Much-Talked-About Huntington’s Disease Therapy Gets A UK Boost

• The boost comes after the U.S. Food and Drug Administration indicated in March that its trial data are not sufficient to support approval.
• The company will meet with the FDA in Q2 to discuss a potential Phase 3 trial design
• Beyond the U.S. and U.K., the company is exploring additional regulatory pathways in international markets.

Shares of uniQure N.V. (QURE) jumped 8% on Thursday as investors cheered progress on its Huntington’s disease therapy, with the company outlining plans to seek U.K. approval later this year.

uniQure said it expects to submit a Marketing Authorization Application (MAA) to the Medicines and Healthcare products Regulatory Agency (MHRA) in the third quarter (Q3) of 2026, following positive discussions on data and manufacturing requirements. The filing will be based on three-year data from ongoing early-stage trials, which showed a 75% slowing of disease progression at higher doses.

Beyond the U.S. and U.K., the company said it is exploring additional regulatory pathways in international markets.

“We are encouraged by the constructive feedback from the MHRA as we continue to work toward a regulatory submission for AMT-130 in Huntington’s disease, which we now expect to submit in the third quarter of this year,” said Matt Kapusta, CEO of uniQure.

Meeting With FDA In Q2 After Earlier Data Was Deemed Insufficient

The boost comes after the U.S. Food and Drug Administration (FDA) indicated in March that its early-stage trial data are insufficient to support approval and recommended that the company run a larger, randomized, controlled study.

Since then, uniQure has been granted a Type B meeting with the FDA in the second quarter (Q2) of 2026, during which it plans to discuss the design of a potential Phase III trial and receive feedback on its analysis plan for four-year data expected by the third quarter.

AMT-130 is a gene therapy to reduce levels of the Huntingtin protein in the brain. It uses a virus to deliver genetic instructions that help lower the protein. The treatment is administered directly into the striatum, an area of the brain heavily affected by Huntington’s disease, through a surgical procedure.

Will Vinay Prasad’s Reported Departure Fastrack Approval?

Earlier, Wells Fargo said the outlook for AMT-130 could improve after reports that Vinay Prasad will leave the FDA by the end of this month.

Prasad, who serves as both the Chief Medical and Scientific Officer and the Director of the Center for Biologics Evaluation and Research at the FDA, has been a polarizing figure, reportedly drawing criticism for decisions that overrode agency scientists and rejected potential drugs.

The firm also noted that criticism from the media and the Huntington’s disease community over the FDA’s push for a new Phase 3 trial shows strong support for the therapy, which could help its path to approval and commercialization.

How Did Retail Traders React?

Retail sentiment for QURE on Stocktwits turned ‘bullish’ from ‘neutral’ a day earlier, while message volumes on the platform exceeded 100% over a 24-hour period.

One user called the stock’s movement an “underreaction.”

QUR shares have declined more than 32% so far in 2026.\

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