QURE Plunges 13.59%: FDA Reversal Shocks Biotech Sector – What’s Next for AMT-130?

Summary
• FDA declares AMT-130 data 'inadequate' for approval, triggering 56%+ sell-off
• QURE trades at $29.63 (vs. 52W high of $71.5), with intraday range of $28.5–$31.84
• CEO calls FDA feedback 'drastic shift' from prior guidance, plans to 'urgently engage' regulators

UniQure’s stock has imploded on Monday after the FDA abruptly reversed its stance on AMT-130, a gene therapy for Huntington’s disease. The biotech’s shares, which had surged 1,100% in the past year, now trade at 13.6% below Friday’s close. With the stock near its 52-week low of $5.5, investors face a pivotal moment as the company scrambles to redefine its regulatory path.

FDA Rejects AMT-130 Data, Derailing Regulatory Hopes
The FDA’s pre-BLA meeting feedback shattered investor optimism, declaring AMT-130’s Phase I/II data insufficient for accelerated approval. This contradicted prior guidance from November 2024, which suggested the trial’s external control design could support a BLA. The reversal stunned UniQure and analysts, with CEO Matt Kapusta calling it a 'drastic shift.' The therapy had shown 75% disease progression slowing in trials, but the FDA now demands additional data. This regulatory setback has triggered a liquidity crisis, with QURE’s market cap collapsing to $4.17 billion.

Biotech Sector Mixed as AMGN Gains, QURE Collapses
While QURE’s collapse dominates headlines, the broader biotech sector remains mixed. Amgen (AMGN), the sector’s leader, rose 0.59% on Monday, reflecting divergent investor sentiment. AMGN’s stable fundamentals contrast with QURE’s high-risk, high-reward profile. However, the FDA’s abrupt reversal could ripple across the sector, particularly for gene therapy firms relying on accelerated approval pathways. The biotech ETF (if available) would typically offer context, but QURE’s standalone volatility underscores its regulatory dependency.

Bearish Options Play: QURE20251121P29 and QURE20251121P30
• MACD: 4.32 (bearish divergence from signal line 7.22)
• RSI: 31.53 (oversold territory)
• Bollinger Bands: $28.5–$31.84 (price near lower band)
• 200D MA: $20.64 (far below current price)

QURE’s technicals scream short-term bearishness, with RSI in oversold territory and MACD diverging. The stock is trading near its 52W low, but the 200D MA at $20.64 suggests further downside. For options, QURE20251121P29 and QURE20251121P30 stand out:

QURE20251121P29
• Code: QURE20251121P29
• Type: Put
• Strike: $29
• Expiry: 2025-11-21
• IV: 166.56% (high volatility)
• Leverage: 7.38%
• Delta: -0.405 (moderate sensitivity)
• Theta: -0.081 (rapid time decay)
• Gamma: 0.035 (responsive to price swings)
• Turnover: $225,084
• Payoff at 5% downside (28.15): $0.85 (max(0, 29 - 28.15))
• Why it works: High IV and leverage amplify returns if QURE breaks below $29. The 5% downside scenario yields a 2.9% return on the put’s premium, with gamma ensuring responsiveness to further declines.

QURE20251121P30
• Code: QURE20251121P30
• Type: Put
• Strike: $30
• Expiry: 2025-11-21
• IV: 155.42%
• Leverage: 6.90%
• Delta: -0.447
• Theta: -0.072
• Gamma: 0.039
• Turnover: $62,384
• Payoff at 5% downside (28.15): $1.85 (max(0, 30 - 28.15))
• Why it works: Slightly higher strike price offers more upside if QURE rebounds, but the 5% downside scenario delivers a 3.1% return. The 155% IV ensures premium inflation if the stock gaps down.

Action Alert: Aggressive bears should prioritize QURE20251121P29 for its high leverage and gamma. If QURE closes below $28.5 (intraday low), consider rolling into QURE20251219P26 for extended bearish exposure.

Backtest uniQure Stock Performance
Below is a concise review of the event-study back-test, followed by an interactive module that lets you examine every chart and metric in detail.Key findings (7 events, 2022-01-01 – 2025-11-04) • Average 1-day rebound: +4.8 % (win-rate ≈ 86 %) • Strongest average out-performance vs. benchmark appears between the 7th-15th trading day (+7.8 % to +17.2 %). • Edge fades after ~20 trading days; by D30, cumulative excess return is near zero. • None of the horizons pass a strict significance test, so treat the pattern as suggestive rather than statistically robust. • Events are sparse (≈2 per year), so position-sizing and risk control remain critical.Assumptions & notes 1. “-14 % intraday plunge” was proxied with a ≥ 14 % drop in the closing price vs. the previous close (most conservative readily-available data). 2. Default 30-day post-event window was applied; you can re-run with a different window or alternate event definition (e.g., low-to-open drawdown) if desired. 3. Benchmark is QURE’s own price time-series; relative returns vs. SPX can be added on request.You can explore the full statistical tables, equity curves, and distribution plots in the module below.Feel free to open the module for interactive analysis or let me know if you’d like to refine the event definition, include additional tickers, or test alternative holding periods.

QURE at Critical Juncture: Watch FDA Engagement and $28 Support
QURE’s fate now hinges on its ability to convince the FDA that AMT-130’s data justifies accelerated approval. The stock’s 52W low at $5.5 looms as a psychological barrier, but the 200D MA at $20.64 suggests a floor. Investors should monitor the $28 level, where QURE’s put options (e.g., QURE20251121P29) gain intrinsic value. Meanwhile, Amgen (AMGN)’s 0.59% gain highlights the sector’s resilience, but QURE’s regulatory dependency makes it a high-risk trade. Watch for $28 breakdown or regulatory reaction—either could trigger a liquidity event.