Master Sea🌊

[Master Sea🌊 @Master_SeaSeo]

Don't come crying and hitting the 'buy' button later when the stock is sitting at triple digits. Hold your ground. $QURE 6/8

[Master Sea🌊 @Master_SeaSeo]

@mike98572986 @DesertDweller93 @peter_mantas @HDSA Exactly. Andy might actually be a sleeper agent sent from somewhere to assassinate former FDA Commissioner Makary. 🕵️‍♂️😂

[Master Sea🌊 @Master_SeaSeo]

So the guy who literally called Huntington’s disease patients and their advocates a "swamp" is now knocking on the FDA's door again? The irony is truly unbelievable. The HD community remembers exactly who you are. 🤡
​@mike98572986 @DesertDweller93 @peter_mantas $QURE @HDSA

[mike @mike98572986]

$qure $clpt

Lmao

Somehow I missed this

Scientist Andy got a new job somehow

“HHS spokesperson Andrew Nixon will take a new job helping advise FDA communications and supporting Acting Commissioner Kyle Diamantas.”

https://t.co/s3NqMk7ShB

[Master Sea🌊 @Master_SeaSeo]

@mike98572986 FXXK!! Is that real? Real-estate professional guy?

We're the SWAMP

[Master Sea🌊 @Master_SeaSeo]

@BisahiroMakga Repl approval

[Master Sea🌊 @Master_SeaSeo]

Still cheap. Absurdly cheap. Not even close to fair value—the market is completely sleeping on this stock right now. $QURE

[Master Sea🌊 @Master_SeaSeo]

Once the 4-year data drops in Sept and the FDA regulatory overhang is officially cleared, this "risk discount" will vanish completely.

When the market realizes the path is clear, expect a massive upward revision.

#uniQure #Biotech #AMT130 $QURE (3/3)

[Master Sea🌊 @Master_SeaSeo]

Latest Wall St Price Targets for $QURE:
🎯 LEERINK: $70
🎯 MIZUHO: $68
🎯 RBC: $65 (Upside to $84)
🎯 Wolfe: $65 (Upgraded)
🎯 Barclays: $60
But here's the catch: These targets still heavily discount the stock due to lingering regulatory & clinical risks. 🧵(1/3)

[Master Sea🌊 @Master_SeaSeo]

For example, Wolfe upgraded $QURE noting the market currently prices in <50% odds of approval due to AdCom fears. Even their new $65 PT only assumes a 70% probability of success for AMT-130.

Wall Street is playing it safe. These are highly conservative base cases. (2/3)

[Master Sea🌊 @Master_SeaSeo]

@DesertDweller93 Thanks desert!

[Master Sea🌊 @Master_SeaSeo]

3/3 In summary, these discussions focus on structuring the post-approval study framework rather than changing the core submission package.

Once aligned, $QURE expects to proceed with the BLA filing in Q3 as planned. An important milestone to follow closely.

[Master Sea🌊 @Master_SeaSeo]

1/3 A quick overview of what remains to be finalized between $QURE and the FDA ahead of the BLA submission.

As noted in the Q2 call, 3-year data is agreed upon as the primary basis for Accelerated Approval. The current focus is finalizing the confirmatory study design. 🧵👇

[Master Sea🌊 @Master_SeaSeo]

2/3 The key details currently being aligned for the confirmatory trial include: $QURE

• Finalizing the patient sample size
• Fine-tuning powering & efficacy bars for 36-month TFC
• Potential considerations for a pre-specified interim analysis

[Master Sea🌊 @Master_SeaSeo]

6/6 Bottom line: $QURE management isn't pumping—they're executing. Q3 BLA submission, Q3 UK filing, and 4-year data in September. September is set to be a defining catalyst for Huntington’s disease & gene therapy.

[Master Sea🌊 @Master_SeaSeo]

5/6 FDA agreed sham procedures are no longer required for confirmatory trials. Meanwhile, Q2 SG&A rose as $QURE aggressively hires commercial launch teams. With $ 810M+ cash funding operations into 2030, runway is fully de-risked.

[Master Sea🌊 @Master_SeaSeo]

4/6 Total biological proof: The Sept update won't just cover clinical scales (cUHDRS/TFC)—it includes CSF NfL change from baseline through 4 years. $QURE is set to prove hard neuroprotective efficacy, not just clinical scores.

[Master Sea🌊 @Master_SeaSeo]

3/6 Statistical rigor at its finest. CMO Walid Abi-Saab revealed the Enroll-HD control database was expanded by 6,000 to ~26,000 participants for the 4-year analysis. You only raise the bar that high if you KNOW your drug signal dominates the noise. $QURE

[Master Sea🌊 @Master_SeaSeo]

2/6 The BLA package for Accelerated Approval is already "complete and self-contained" based on 3-year data aligned with FDA. The upcoming 4-year data isn't a plea for approval—it’s a knockout punch for regulators & Wall St. $QURE

[Master Sea🌊 @Master_SeaSeo]

1/6 Why is $QURE management so quietly confident ahead of the 4-year AMT-130 readout in Sept? CEO Matt Kapusta entered a formal quiet period, stating they "very much look forward to sharing those results". The executive poise speaks volumes. 🧵👇

[Master Sea🌊 @Master_SeaSeo]

Why did UK's NIHR post this 5 days ago? Right when $QURE got their FDA Type B minutes, NIHR officially touted the "75% slowing of disease progression" for HD. They are proudly bragging about the AMT-130 trial at UCLH! Government validation right before ER is NO coincidence.

[Master Sea🌊 @Master_SeaSeo]

@HarrieScarlet Agreed. Charts are mostly noise ahead of such a binary event. The market will solely dictate the stock price based on the upcoming ER call—gauging the management's exact wording, execution plans, and their underlying confidence. $QURE