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uniQure N.V.uniQure N.V.uniQure N.V.

uniQure N.V.

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When Does Progress Move Backward?UniQure N.V. experienced a catastrophic 75% stock plunge in November 2025 following an unexpected FDA reversal on its Huntington's disease gene therapy, AMT-130. Despite having received Breakthrough Therapy Designation and Regenerative Medicine Advanced Therapy designation, the company learned during a pre-BLA meeting that the FDA now considers its Phase I/II data, which relied on external controls from the Enroll-HD natural history database, insufficient for approval. This contradicted prior regulatory guidance and forced UniQure to abandon its planned Q1 2026 submission, immediately destroying billions in market capitalization and rendering near-term revenue projections obsolete.   The regulatory reversal reflects broader instability within the FDA's Center for Biologics Evaluation and Research (CBER), where leadership turnover and philosophical shifts have created systemic uncertainty across the gene therapy sector. New CBER leadership, particularly Director Vinay Prasad, favors traditional evidence standards over accelerated pathways that rely on surrogate endpoints or external controls. This policy hardening invalidates development strategies that biotechnology companies had pursued based on previous regulatory assurances, demonstrating that breakthrough designations no longer guarantee acceptance of innovative trial designs.   The financial consequences extend beyond UniQure's immediate valuation collapse. Every year of regulatory delay erodes patent exclusivity. AMT-130's patents expire in 2035, directly destroying net present value. Analysis suggests that a three-year delay could render 33-66% of rare disease therapies unprofitable, and UniQure now faces the prospect of funding expensive randomized controlled trials while operating with negative profit margins and declining revenues. The company's only viable hedges involve pursuing approval through European regulators (EMA) or the UK's MHRA, where regulatory philosophies may prove more accommodating.   This case serves as a critical warning for the entire gene therapy sector: accelerated approval pathways are contracting, single-arm trials using external controls face heightened scrutiny, and prior regulatory agreements carry diminishing reliability. Investors must now price significantly higher regulatory risk premiums into biotech valuations, particularly for companies dependent on single assets and novel trial methodologies. The UniQure experience confirms that in biotechnology investment, regulatory predictability, not just scientific innovation, determines commercial viability.
NASDAQ:QUREShort
by UDIS_View
uniQure N.V - Positive divergenceOn the above 2-week chart uniQure N.V. price action has corrected 90% without the aid of share splits. A number of reasons now exist to consider a long position. They include: 1) Price action returns to legacy support. 2) RSI resistance breakout. 3) Strong positive divergence as measured over a 2-month period. Look left. 4) No share splits. 5) Price action previously topped out at the Fibonacci 1.414. Were that performance to repeat price action would top out at $215 with a 3600% return. Is it possible price action continues to correct? Sure. Is it probable? No. Ww Type: Investment Risk: <6% Timeframe for long: Qrt 1 2024 Stop loss: Will say elsewhere
NASDAQ:QURELong
by without_worries
8
QURE – Gene Therapy Play Gaining MomentumuniQure N.V. NASDAQ:QURE is a leading gene therapy biotech targeting rare diseases like Huntington’s and hemophilia. 🔹 Bullish setup forming above $14.50–$15.00 🔹 Price Target: $28.00–$29.00 📈 Catalyst: FDA alignment on its Huntington’s program (AMT-130) clears the path for a BLA submission in Q1 2026, significantly derisking the development. ✅ Early data from AMT-130 is promising, tracking well with clinical and biomarker endpoints — potential first-mover in disease-modifying therapies for Huntington’s. 🧠 Expanding platform: AMT-260 (epilepsy) delivered a 92% seizure reduction in initial patient, showcasing pipeline breadth across CNS disorders. 🧬 QURE offers exposure to the fast-growing gene therapy space with high long-term upside potential if clinical momentum continues. #QURE #GeneTherapy #BiotechStocks #FDA #BreakoutSetup #LongSetup #RareDiseases #HuntingtonsDisease #Epilepsy #SmallCapStocks #GrowthStocks #Healthcare #BiotechInvesting #TechnicalAnalysis #StockWatchlist #Bullish
NASDAQ:QURELong
by Richtv_official
2
$QURE Is A Hight Tight Flag - Here's How I Plan To Trade ItOf course I have no idea how the price of NASDAQ:QURE is going to open Monday morning, but if it opens within the body of Friday's candle or a little lower, I'll buy it two times as it breaks above 18.13 and then 18.50. I'll set my stop to the low of the day and see what develops. Having moved up 150% in just 14 days it's an awfully powerful stock and deserves my attention here as it flags out with an acceptable 20% pullback. I don't know what my position size is going to be on it yet. I have to wait and see where the low of the day is first and then decide how much capital to allocate. If risk is tight enough I'll get to full size buying one half above 18.13 and the second above 18.50. I'll likely have to use limit buys here because it could move very quickly on me. Doing so means I risk not getting filled but it also means I don't end up taking on an uncomfortable amount of risk either. Of course I drew my yellow line that I hope to see Monday off the chart and on the moon! Hopefully if that happens I'm well positioned. We will see what Monday brings, but this is my number one priority at the opening bell.
NASDAQ:QURELong
by CardinalRuleTrader
5
$QURE - UniQure - Oversold and Indicator breakout. Target $30+Entry Price: $18.90 Stop Loss: $13.00 Take Profit: $25-$30 (=25% to +50%) Technical Analysis - Oversold on daily and weekly charts - low RSI and William %R - Attempting a breakout above key MA's on the daily and retracing on the weekly. - Formed a wedge/consolidated on the daily chart - Key breakout on daily and weekly DMI - Buy zone of $17-$20 - Target zones of $25-$30 (+25% to +50%) Analyst Rating - But with Target price $55
NASDAQ:QURELong
by subtlepapi
WATCH $QUREBullish Fundamental - High inflationary Macro environment / Market has no fear sentiment - Funds Accumulation - Positive PE - Decent PEG - Positive P/FCF - Strong Sector / Industry - Biotech seems to be breaking out Technical - Momentum Theory Indicator - bottomed and broke out neckline - Price action formation ( falling wedge ) - Broke out Trend line with volume - Price above 200MA - Price above POC - Broke ST - Engulfing candle follow through Entry idea - For members Stop loss depending on entry and risk appetite. But always set meaningful stops. "the prize is in the process" Cheers and happy trading!
NASDAQ:QURELong
by nexxtrade
QURE Technical Analysis 🧙uniQure NV is a gene therapy company. It develops treatment and platform for patients suffering from genetic and other devastating diseases. Its products and services are focused on hemophilia, Huntington's disease, and cardiovascular diseases. The company is focused on the development of the pipeline of gene therapies with the collaboration of Bristol Myers-Squibb for cardiovascular diseases. If you understand the idea,🎯 press a thumb up! 👍 Have a question? Don't be shy to ask! 🤓 Interested to study how to analyze charts, follow me!
NASDAQ:QURELong
by trading_as_bus