CELC Surges 9% on FDA NDA Acceptance: A Biotech Breakout with High-Leverage Options in Play

Summary
• Celcuity (CELC) surges 9.01% to $54.46, hitting a 52-week high of $55.44
• FDA accepts gedatolisib NDA under expedited RTOR program, signaling potential 2025 approval
• Analysts raise price targets to $66–$79, with stock trading above $2.1B valuation

Celcuity’s dramatic intraday rally has thrust the biotech stock into the spotlight, driven by regulatory momentum and bullish analyst sentiment. The FDA’s acceptance of its New Drug Application for gedatolisib under the Real-Time Oncology Review program has triggered a surge in investor optimism. With the stock trading at a 210% year-to-date gain and analysts projecting a $60–$79 price range, CELC’s trajectory reflects a confluence of clinical progress and market speculation.

FDA's RTOR Acceptance Catalyzes CELC's Rally
Celcuity’s 9.01% surge stems from the FDA’s decision to review its gedatolisib NDA under the expedited Real-Time Oncology Review (RTOR) program. This pathway allows early submission of topline data, accelerating the approval timeline for HR+/HER2- advanced breast cancer treatment. The NDA, supported by Phase 3 VIKTORIA-1 trial results showing a 76% reduction in disease progression risk with the gedatolisib-triplet regimen, has positioned the drug as a potential blockbuster. The FDA’s acceptance, coupled with Breakthrough Therapy and Fast Track designations, has galvanized investor confidence in Celcuity’s pipeline and commercial potential.

Biotech Sector Volatile Amid Mixed Regulatory News
The biotech sector remains fragmented, with Celcuity’s rally contrasting against Amgen’s (AMGN) 0.99% decline. While Celcuity benefits from FDA-driven optimism, peers like Prothena face setbacks due to ARIA trial issues in Alzheimer’s. The sector’s mixed performance underscores the high-stakes nature of regulatory decisions, where positive data can propel individual stocks despite broader market caution.

High-Leverage Options and ETFs for CELC’s Volatile Trajectory
• 200-day average: 15.77 (far below current price)
• RSI: 64.85 (neutral to overbought)
• MACD: 6.38 (bullish divergence from signal line 7.49)
• Bollinger Bands: Price at 55.05 (near upper band 55.95)

Celcuity’s technicals suggest a continuation of its bullish momentum, with key resistance at $55.95 and support at $47.66. The stock’s 64.85 RSI and MACD divergence indicate potential for further gains, though overbought territory (RSI >60) warrants caution. High-liquidity options like CELC20250919C55 and CELC20251017C55 offer leveraged exposure to this move.

Top Option 1: CELC20250919C55
• Code: CELC20250919C55
• Type: Call
• Strike: $55
• Expiry: 2025-09-19
• IV: 56.64% (moderate)
• LVR: 17.20% (high)
• Delta: 0.537 (moderate sensitivity)
• Theta: -0.116 (rapid time decay)
• Gamma: 0.0508 (high sensitivity to price swings)
• Turnover: 8,870 (liquid)
• Payoff at 5% upside (57.80): $2.80/share
This call option balances leverage and liquidity, ideal for capitalizing on a short-term breakout above $55.95.

Top Option 2: CELC20251017C55
• Code: CELC20251017C55
• Type: Call
• Strike: $55
• Expiry: 2025-10-17
• IV: 62.78% (high)
• LVR: 10.38% (moderate)
• Delta: 0.557 (moderate sensitivity)
• Theta: -0.071 (moderate decay)
• Gamma: 0.0306 (moderate sensitivity)
• Turnover: 12,835 (highly liquid)
• Payoff at 5% upside (57.80): $2.80/share
This option offers extended time decay and liquidity, suitable for a mid-term hold as Celcuity’s NDA submission nears Q4 2025.

Aggressive bulls should target a breakout above $55.95 with CELC20250919C55, while longer-term players may favor CELC20251017C55 for a post-RTOR approval rally.

Backtest Celcuity Stock Performance
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CELC’s FDA-Driven Rally: A Biotech Breakout with High Leverage Options in Play
Celcuity’s 9.01% surge underscores the transformative power of regulatory milestones in biotech. With the RTOR program accelerating its NDA timeline and analysts projecting $60–$79 price targets, the stock’s trajectory remains bullish. However, its 64.85 RSI and overbought status suggest caution for near-term pullbacks. Investors should monitor the $55.95 upper Bollinger Band and $47.66 support level. Meanwhile, sector leader Amgen’s 0.99% decline highlights the sector’s volatility. Aggressive traders should initiate long positions in CELC20250919C55 if $55.95 breaks, while hedging with a stop-loss below $52.89.