uniQure's QURE Plummets 13.6% on FDA Rejection of Gene Therapy Data – What's Next for Biotech's High-Risk Play?

Summary
• uniQure (QURE) plunges 13.6% intraday to $22.015, a 10-month low, amid FDA skepticism over AMT-130 data
• Intraday range of $21.00–$23.98 highlights sharp volatility as turnover surges to 6.58M shares
• Options chain sees 5,962 contracts traded on QURE20260116P20 put, signaling bearish positioning

uniQure’s stock is in freefall after the FDA signaled AMT-130’s Phase I/II data may not support a Biologics License Application (BLA) for Huntington’s disease. The 13.6% drop reflects a 52-week low of $7.02 and a dynamic PE of -6.35, underscoring the sector’s risk-on sentiment. With 6.58M shares traded and a 11.6% turnover rate, the sell-off has triggered a cascade of options activity, particularly in January 2026 expirations.

FDA Casts Doubt on AMT-130 Data, Sparking Sharp Sell-Off
The FDA’s final meeting minutes for AMT-130, a gene therapy for Huntington’s disease, revealed that Phase I/II data lacks the statistical robustness to justify a BLA submission. This marks a reversal from prior regulatory optimism, with the agency now demanding additional evidence. uniQure’s CEO emphasized plans to request a follow-up meeting in Q1 2026, but the market has priced in near-term uncertainty. The 13.6% drop aligns with the stock’s 52-week low and reflects a -6.35 dynamic PE, highlighting the sector’s sensitivity to regulatory outcomes.

Biotech Sector Volatile as AMT-130 Fallout Spreads
The biotech sector remains in flux as AMT-130’s setbacks ripple through investor sentiment. Amgen (AMGN), the sector’s leader, fell 1.3% intraday, reflecting broader risk-off behavior. While AMGN’s decline is modest compared to QURE’s collapse, the sector’s mixed performance underscores the high-stakes nature of regulatory decisions. With 2025 biotech news highlighting breakthroughs in gene editing and AI-driven drug discovery, AMT-130’s delay could delay momentum in Huntington’s disease therapies.

Options Playbook: Puts and Calls for QURE's Volatile Outlook
• RSI: 15.17 (oversold), MACD: -5.10 (bearish), 200D MA: $22.03 (near current price)
• Bollinger Bands: $24.68–$31.39 (QURE trading near lower band), 30D support/resistance: $27.13–$28.04

QURE’s technicals suggest a short-term bearish bias, with RSI at oversold levels and MACD signaling bearish momentum. The 200D MA at $22.03 aligns with current price, indicating potential consolidation. For options, two contracts stand out:

• QURE20251219P21 (Put): Strike $21, Expiry 12/19, IV 100.45%, Delta -0.367, Theta -0.0306, Gamma 0.0813, Turnover $6,374. This put offers high leverage (16.68%) and moderate delta, ideal for a 5% downside scenario where payoff = max(0, $20.91 - $21) = $0.00. The high gamma and IV suggest sensitivity to price swings.
• QURE20260116P25 (Put): Strike $25, Expiry 1/16/26, IV 101.46%, Delta -0.568, Theta -0.0186, Gamma 0.0507, Turnover $256,414. This put’s high liquidity and moderate delta make it a hedge against a prolonged decline. Payoff = max(0, $20.91 - $25) = $4.09, offering downside protection.

Aggressive bears may consider QURE20251219P21 for short-term volatility, while QURE20260116P25 suits a longer-term bearish stance. Watch for a breakdown below $21 to validate the put thesis.

Backtest uniQure Stock Performance

Biotech's High-Stakes Gamble: QURE's Next Move Could Define 2026
uniQure’s 13.6% drop reflects the FDA’s skepticism over AMT-130, but the stock’s proximity to its 200D MA and oversold RSI suggest a potential rebound. Investors should monitor the January 2026 put expirations and the company’s follow-up meeting with the FDA. Amgen’s 1.3% decline highlights sector-wide caution, but QURE’s options activity indicates a high-risk, high-reward setup. For now, watch the $21 support level and the January 2026 put expirations for directional clues. If the $21 level breaks, QURE20251219P21 offers a high-leverage play on the downside.