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The public excerpt of STAT’s Oct. 1, 2026, feature identifies Lauren Holder as an advocate living with early-stage Huntington’s disease and says reporter Adam Feuerstein asked her to react to new results for uniQure’s experimental gene therapy AMT-130. The excerpt does not give her explanation or a direct quotation, so her personal reasons cannot be stated reliably from the material available here.
The results themselves offer context for the “waning effect” framing: uniQure reported a smaller relative slowing on one measure at four years than at three, but a similar result on another. Those are company comparisons with matched natural-history controls—not proof that the treatment’s effect wore off, nor proof of lasting benefit.
What does “waning effect” mean in the four-year update?
In its Sept. 29, 2026, update, uniQure reported two different measures of disease progression for participants who received the high dose. At 48 months, the company reported 44% slowing on the composite Unified Huntington’s Disease Rating Scale (cUHDRS) and 61% slowing on Total Functional Capacity (TFC), each compared with a matched external control group. The cUHDRS result did not reach statistical significance; the TFC result had a nominal p-value of 0.008.
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The figures are relative slowing of progression versus the comparison group. They do not mean that participants regained lost abilities or that symptoms improved by those percentages. cUHDRS is a composite measure; TFC assesses functional capacity. They capture related but distinct aspects of Huntington’s disease, so a change on one should not be treated as a change on the other.
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How do the three- and four-year figures compare?
The appropriate comparison is each measure against itself over time. uniQure’s Sept. 24, 2025, topline release gave the 36-month high-dose results; its Sept. 29, 2026, release reported the 48-month results. Both sets were compared with matched external controls, and each cited high-dose analysis included 12 participants.
| Measure | 36 months | 48 months |
|---|---|---|
| cUHDRS | 75% reported slowing versus matched external controls; 12 high-dose participants. uniQure, Sept. 24, 2025. | 44% reported slowing versus updated matched external controls; 12 high-dose participants; not statistically significant (nominal p=0.144). uniQure, Sept. 29, 2026. |
| TFC | 60% reported slowing versus matched external controls; 12 high-dose participants. uniQure, Sept. 24, 2025. | 61% reported slowing versus updated matched external controls; 12 high-dose participants; nominal p=0.008. uniQure, Sept. 29, 2026. |
On cUHDRS, the reported relative slowing was lower at 48 months than at 36 months, and the four-year finding was not statistically significant. On TFC, the reported percentage was similar at both time points. That is why saying the effect “waned” captures one reported measure but overstates the evidence if it is taken to mean every measured result declined or that the therapy stopped working.
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What makes the four-year comparison uncertain?
These were Phase I/II study results compared with propensity-score-matched participants from an ENROLL-HD natural-history dataset, not a four-year randomized comparison against sham surgery. The 48-month analysis included 12 participants in each dose group, according to uniQure’s Sept. 29, 2026, release. A comparison with an external group can provide context, but it does not control uncertainty in the same way as a randomized concurrent control group.
uniQure reported that 53% of the matched external controls had missing data at 48 months. The company said people who discontinued follow-up were progressing materially faster than those who remained, and argued that this likely understated progression in the control group and the apparent treatment effect. That is uniQure’s interpretation of the missing data; it is not an independently established correction to the results.
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The company also reported that mean cerebrospinal-fluid neurofilament light (NfL) at 48 months was 4% above baseline among 11 participants. NfL is a biomarker, not a direct measure of a person’s day-to-day function, and it should not be substituted for either clinical scale.
What is AMT-130, and is it approved?
AMT-130, also called ifezuntirgene inilparvovec, is an investigational one-time gene therapy for Huntington’s disease. uniQure says it uses an adeno-associated virus (AAV) vector to deliver a microRNA intended to reduce production of huntingtin, including both disease-causing mutant huntingtin and normal huntingtin. Administration is neurosurgical. AMT-130 is not an approved treatment.
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Regulatory status is a separate question from whether the trial results look encouraging. In a March 2, 2026, community letter hosted by the Huntington’s Disease Society of America, uniQure said FDA did not agree that the Phase I/II external-control comparisons provided sufficient primary evidence of effectiveness to support a marketing application. The company said FDA strongly recommended a prospective, randomized, double-blind, sham surgery-controlled Phase III study. This is uniQure’s account of the FDA meeting minutes; the letter said discussions with FDA would continue.
What can be said about Lauren Holder’s reaction?
STAT’s accessible Oct. 1, 2026, excerpt says Holder lives with early-stage Huntington’s disease, is an advocate, and was asked for her reaction to the update. It does not reveal her reasoning, quote her, or establish what personal experience shaped her view. The four-year results may help explain why “waning” is not a complete description of the company’s two measures, but they cannot be presented as Holder’s explanation.
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