$QURE — FinTwit mentions on Surfaced

$QURE — FinTwit mentions on Surfaced

Recent calls

16 calls

@stocksavvyshayJun 17, 2026 · 1:44 PM

$CLPT is up 34% after the FDA allowed $QURE to use three-year Phase I/II AMT-130 data as primary basis for an accelerated approval BLA filing planned for Q3 2026. ClearPoint is moving because AMT-130 is delivered directly into the brain using its navigation system and SmartFlow cannula meaning every trial procedure and potentially every commercial procedure if approved runs through its platform.

@adamfeuersteinJun 17, 2026 · 1:24 PM

Re $QURE news, I texted w/ Lauren Holder, a Huntington’s disease advocate who is also living with the early stages of the disease. Here's what she said: “I'm literally crying right now. I'm so happy that I don't even know how to put what I'm feeling into words.” She added, “This is the best-case scenario for our community,” she added. “This happened because of advocacy. This happened because dedicated patient advocates refused to give up, because this community continued to show up, speak up, and fight, even when it felt like no one was listening. Today, it feels like we were finally heard."

@adamfeuersteinApr 30, 2026 · 11:23 AM

$QURE -- Submission of a UK Marketing Authorization Application for AMT-130 is expected in the third quarter of 2026 -- Type B Meeting with U.S. FDA granted in second quarter; expect to discuss potential Phase III design and analysis plan for AMT-130 four-year data https://t.co/Y5slZ33fKB

@adamfeuersteinMar 6, 2026 · 4:27 PM

New from me on $QURE and FDA. Free, no paywall. The FDA, urged to avoid controversy, creates a new headache with attack against UniQure Anonymous diatribe from a senior official plunges agency back into headlines https://t.co/ceDE0TXjdI

@adamfeuersteinMar 3, 2026 · 12:19 PM

Read more on $QURE and FDA from me here: FDA is ‘not convinced’ UniQure’s Huntington’s therapy has benefit, senior official says Company accuses agency of reversal but hopes to settle on parameters of a new trial https://t.co/YVIUYiaCMz

@adamfeuersteinMar 2, 2026 · 12:38 PM

$QURE UniQure plans to seek approval for Huntington’s therapy still blocked by FDA https://t.co/jqzDB5bTWS

@kaizen_investorMar 2, 2026 · 12:29 PM

$QURE drops 45% after earnings. That painful 45% drop makes sense given the severe regulatory roadblocks just announced. The biggest blow is the FDA rejecting early approval for their Huntington's therapy. The agency now demands a time-consuming trial where some patients receive a fake surgery as a placebo, pushing potential approval years away. Adding to the pain, their Fabry disease and ALS treatments are both paused due to safety concerns like liver toxicity. The only silver linings are an advancing epilepsy program and a massive $622.5 million cash pile. Thankfully, this money secures their operations until late 2029.

@adamfeuersteinFeb 26, 2026 · 2:28 PM

$QURE down this morning on comments made by FDA Commissioner Marty Makary to CNBC's Becky Quick. In a discussion about rare-disease drug approvals and Vinay Prasad, Makary said this: "I think there has been a bit of an effort to find a boogeyman to account for certain products that were not approved. For example, there was a product where the researchers drilled a burr hole, literally hole in people's skulls to interact inject intrathecally into the ventricle, a therapy the randomized control trial. At the end of the randomization period, it's found no benefit, and yet, this is one of the drugs that we were pressured to approve. Now, look, I have a lot of sympathy for those patients. There's nothing out there to offer them, but we're not going to go ahead and approve something like that that has morbidity associated with it."

@adamfeuersteinJan 9, 2026 · 12:14 PM

$QURE said FDA meeting scheduled to discuss AMT-130. No timing provided.

@adamfeuersteinDec 4, 2025 · 12:11 PM

$QURE FDA update: In the final meeting minutes, and consistent with uniQure’s November 3, 2025 press release, the FDA conveyed that data submitted from the Phase I/II studies of AMT-130 are currently unlikely to provide the primary evidence to support a BLA submission. uniQure is carefully evaluating the feedback and plans to urgently request a follow-up meeting with the FDA to take place in the first quarter of 2026.

@adamfeuersteinNov 10, 2025 · 2:08 PM

$QURE Q&A largely uneventful Mgmt confirmed FDA guidance from Nov. 2024 meeting was study data+ECA supported a BLA filing. Doesn't expect new mtg meetings to change FDA shift, but hope it outlines concerns in more detail and how to address. "100% committed" to work with FDA to determine a path forward for an expedited BLA filing. Stifel's Paul Matteis: Did you ask FDA why they changed their mind? What did they say? Kapusta: Not going to comment on the details of the meeting.

@adamfeuersteinNov 6, 2025 · 2:27 PM

This week's Biotech Scorecard newsletter: The FDA is a mess, but don't blame it for everything I write about $QURE and $BHVN Re: Uniqure and its gene therapy for Huntington's disease, the dissonance between the FDA's words and actions can be confusing. Approving AMT-130 seems like a no-brainer win for the FDA and the policy initiatives pushed by its leadership. The reversal certainly has Prasad's conservative data-stickler fingerprints all over it, BUT... You have to consider the possibility that there is a significant issue with the AMT-130 data, the composition of the external control group, or both, that Uniqure hasn’t disclosed. Slingshot Insights hosted a call Tuesday with an HD physician who was critical of the AMT-130 data, saying the therapy was "far from ready for approval."

@adamfeuersteinNov 3, 2025 · 12:27 PM

On $QURE: I wrote this in my Sept. 25 newsletter: "Bear in mind: What we have seen so far of the AMT-130 data are mentioned in a Uniqure press release. Fairly detailed, yes, but it will be important to see the data fully presented at a future medical meeting and published in a peer-reviewed journal. The validity of external control arms like the one used by Uniqure is still hotly debated, even as regulators, including the Food and Drug Administration, allow them under certain circumstances. It’s been lost to memory, but recall that the AMT-130 study started with a true, sham-surgery control arm that showed no benefit for the gene therapy. It was only after the company reconfigured the study and started using natural history comparators was a benefit observed." To be clear: I was also very positive on the data and its regulatory stance at the time. I thought this was a gene therapy that would be approved, even with Vinay in charge. That looks wrong now, unless we see another pivot a la $REPL.

@adamfeuersteinOct 7, 2025 · 8:46 PM

@A_May_MD @BlaseBio I would say Cathie Wood staying out of $QURE would be a bullish sign.

@benitozSep 24, 2025 · 11:25 PM

I’ve always been skeptical of gene therapy—too many risks: immune, off-target, durability, delivery. But $QURE Huntington’s data suggests brain diseases may be its true platform unlock. Here’s a better patient outcomes. 🧬🧠 https://t.co/m2TTaDGpLI

@adamfeuersteinSep 24, 2025 · 11:05 AM

$QURE Also AMT-130 showed stat sig 60% disease slowing on TFC, assesses patients’ ability to work, drive and perform other functions of daily life. NfL also lower. Gene therapy isn't for everyone, but these results are a big win. Story here: https://t.co/XByXgHDZeF