The reported four-year results for uniQure’s experimental Huntington’s disease gene therapy are mixed across two measures: the company reported less slowing on one measure than it had at three years, but not on the other. The accessible excerpt of STAT’s Oct. 1, 2026 feature identifies Lauren Holder as an early-stage Huntington’s disease advocate and says reporter Adam Feuerstein called to ask her reaction. It does not include her explanation or a direct quotation, so it cannot establish why she was not fazed.
What did the four-year AMT-130 results show?
On Sept. 29, 2026, uniQure reported 48-month results from its ongoing Phase I/II studies of AMT-130, also called ifezuntirgene inilparvovec. The results used clinical data through June 30, 2026. For the high-dose group, 12 participants were analyzed at 48 months. The company compared their outcomes with propensity-score-matched participants from an updated ENROLL-HD natural-history dataset—not with a randomized sham-surgery control group.
| Measure | 36 months | 48 months |
|---|---|---|
| cUHDRS | 75% reported slowing versus matched external controls; 12 high-dose participants, according to uniQure’s Sept. 24, 2025 topline release. | 44% reported slowing versus updated matched external controls; 12 high-dose participants. The comparison did not reach statistical significance (nominal p=0.144), according to uniQure’s Sept. 29, 2026 release. |
| Total Functional Capacity (TFC) | 60% reported slowing versus matched external controls; 12 high-dose participants, according to uniQure’s Sept. 24, 2025 topline release. | 61% reported slowing versus updated matched external controls; 12 high-dose participants. The reported nominal p-value was 0.008, according to uniQure’s Sept. 29, 2026 release. |
The figures describe relative slowing compared with an external-control group; they do not mean symptoms were reversed or that participants improved by those percentages. cUHDRS and TFC are distinct clinical measures, not interchangeable scores. The 48-month cUHDRS comparison’s nominal p-value also does not establish a treatment effect with statistical certainty.
Did the treatment effect wane after three years?
That depends on which measure is meant. Comparing like with like, uniQure’s reported cUHDRS slowing was 75% at 36 months and 44% at 48 months; the later comparison was not statistically significant. On TFC, the reported slowing was 60% at 36 months and 61% at 48 months. Thus, the cUHDRS percentage was lower at four years, but the reported TFC percentage was not. Calling the change a uniform decline across all measured outcomes would overstate what the figures show.
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The two snapshots also rely on external controls and different analysis dates: the 36-month topline results used data through June 30, 2025, while the 48-month update used data through June 30, 2026, and an updated natural-history dataset. Percentages from those comparisons should be read as sponsor-reported estimates, not as a direct randomized test of whether benefit faded between years three and four.
How much confidence should readers place in the comparison?
External controls can provide a comparison when a study does not include a randomized control group, but they are not equivalent to participants randomly assigned to a sham procedure. The concern is especially relevant here because uniQure reported that 53% of the matched ENROLL-HD controls had missing data at 48 months. The company said people who stopped follow-up were progressing materially faster than those who remained, and that this likely understated progression in the control group and the treatment effect. That is uniQure’s interpretation of the missing data, not an independent finding established by the reported comparison.
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The release also reported that mean cerebrospinal-fluid neurofilament light (NfL) was 4% above baseline at 48 months (n=11). NfL is a biomarker; it is not itself a direct measure of a person’s day-to-day function, and it should not be treated as a substitute for the clinical measures above.
What is known about Lauren Holder’s reaction?
The accessible portion of STAT’s Oct. 1, 2026 feature identifies Holder as a Huntington’s disease advocate living with early-stage disease and says Feuerstein called her for her reaction to the clinical update. It also describes the cUHDRS effect as seeming to have waned between year three and year four, while noting that the change did not alarm uniQure and had prompted outside questions about durability. The remainder is subscriber-only. The available excerpt does not report Holder’s reasons, her specific level of concern, or her personal experience with treatment.
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That distinction matters: uniQure’s view that the results show meaningful slowing is the company’s assessment, not Holder’s stated explanation and not a regulator’s conclusion. The excerpt supports saying that she was asked for her reaction; it does not support attributing a particular argument or quotation to her.
Independent reader supportYour contribution helps us test, update, and keep practical guides available for everyone.What is AMT-130, and where does development stand?
AMT-130 is an investigational, one-time gene therapy delivered by neurosurgery. UniQure says an AAV vector delivers a microRNA intended to reduce huntingtin production, lowering both disease-causing mutant huntingtin and normal huntingtin. It is not an approved treatment or a product available for consumer purchase.
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In a March 2, 2026 community letter hosted by the Huntington’s Disease Society of America, uniQure described its meeting with the FDA: the agency could not agree that Phase I/II comparisons against external controls provided sufficient primary evidence of effectiveness for a marketing application, and strongly recommended a prospective, randomized, double-blind, sham surgery-controlled Phase III study. UniQure said it would continue discussions with the FDA. This is the company’s account of the meeting minutes; it does not change the investigational status of AMT-130.
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