- FDA U-turn triggers crash: uniQure (NASDAQ: QURE) shares fell over 50% in one day after U.S. regulators said current clinical data for its experimental Huntington’s disease gene therapy is not adequate for approvalreuters.com. This reversal comes just weeks after uniQure’s trial results were hailed as “game-changing”fiercebiotech.com.
- Wild price swing: QURE stock plummeted from about $68 to the low-$30s, erasing roughly half of its market value (now ~$2.1 B). It hit an intraday low near $23 before partially rebounding to ~$34, still down ~54% on the news.
- Surprise FDA setback: The FDA no longer agrees that uniQure’s Phase 1/2 data (with external control) can support a BLA (marketing application) under accelerated approvalreuters.com – a “drastic change” from prior guidance, uniQure’s CEO saidglobenewswire.com. The timeline for approval is now unclear, likely delaying any U.S. launch beyond 2026reuters.com.
- Analyst reactions: Experts call this a major regulatory setbackreuters.com. Guggenheim’s analyst noted the FDA now sees uniQure’s analysis as “post hoc” (not pre-specified)reuters.com, and another analyst warned new trials or data may be neededreuters.com. Some have cut price targets (e.g. one lowered from $76 to $53benzinga.com), though the pre-news consensus target was ~$68 with a Strong Buy ratingstockanalysis.com.
- Investor sentiment & fallout: The shock has rattled biotech investors – uniQure’s stock had soared ~300% in September after positive trial data, and now enthusiasm has flipped to disappointment. Shareholder rights law firms quickly launched investigations for potential securities fraud (citing the 57% one-day plunge), reflecting investor outrage.
- Technical picture: Technically, QURE is in free-fall territory. The gap-down left no clear support levels; shares traded in a wide ~$22–$36 range on the crash day. Volume spiked to ~30 million shares (vs. ~1–2 million typical), indicating intense selling pressure. The stock is now well below key moving averages (which sit around $52–$62), suggesting overhead resistance
UniQure Stock Plunges 50% on FDA Shocker – What’s Next for QURE’s Gene Therapy Ambitions?
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