Axsome Therapeutics Soars 23.75% on Intraday Surge: What’s Fueling This Biotech Breakout?

Summary
• Axsome Therapeutics (AXSM) surges 23.75% to $184.14, hitting a 52-week high of $184.395
• FDA grants priority review for Alzheimer’s drug AXS-05, with a PDUFA date of April 30, 2026
• NDA submission for narcolepsy drug AXS-12 expected in January 2026, adding to near-term catalysts

Axsome Therapeutics is experiencing a historic intraday rally, driven by regulatory milestones and robust pipeline progress. The stock’s 23.75% surge to $184.14 reflects investor optimism over its Alzheimer’s and narcolepsy drug candidates. With Auvelity sales growing 69% year-over-year and two major regulatory submissions on the horizon, the biotech is capturing market attention as a high-conviction play in the CNS therapeutics space.

FDA Priority Review and NDA Catalysts Ignite Axsome's Surge
Axsome’s explosive move stems from two critical regulatory developments. The FDA’s priority review designation for AXS-05 (Auvelity) in Alzheimer’s disease agitation accelerates its approval timeline to April 30, 2026, while the upcoming NDA submission for AXS-12 in narcolepsy in January 2026 adds a second near-term catalyst. These milestones validate the company’s pipeline potential, with Auvelity already generating 80% of Q3 revenue and AXS-12 benefiting from Orphan Drug exclusivity. Analysts highlight the unmet medical need in Alzheimer’s agitation and narcolepsy, positioning Axsome as a key player in high-growth CNS markets.

Biotech Sector Volatility Amid Axsome's Surge: Amgen Trails Slightly
While Axsome’s 23.75% rally dwarfs sector averages, the broader biotech index (XBI) remains flat. Sector leader Amgen (AMGN) trades down 0.3%, underscoring Axsome’s outperformance driven by specific regulatory momentum. The biotech sector’s mixed performance highlights Axsome’s unique catalysts—priority review and NDA timelines—versus Amgen’s more mature product portfolio. Investors are rotating into high-conviction biotech plays with clear near-term data readouts, amplifying Axsome’s relative strength.

Options Playbook: High-Leverage Calls and Strategic Puts for Axsome's Volatile Move
• MACD: 2.33 (bullish divergence from signal line 2.73)
• RSI: 57.62 (neutral, avoiding overbought/oversold extremes)
• Bollinger Bands: Price at $184.14 (above upper band $155.39, signaling strong momentum)
• 200D MA: $119.41 (far below current price, indicating long-term bullish trend)

Axsome’s technicals suggest a continuation of its rally, with key support at $146.63 (30D support) and resistance at $184.39 (52W high). The stock’s short-term bearish trend clashes with a long-term bullish setup, making it a high-volatility play. Aggressive bulls should target a breakout above $185, while cautious investors may use the $170–$175 range for strategic entries. No leveraged ETF data is available, but the options chain offers compelling leverage.

Top Option 1: AXSM20260116C185 (Call)
• Strike: $185, Exp: Jan 16, 2026
• IV: 37.74% (moderate)
• Leverage Ratio: 33.97% (high)
• Delta: 0.484 (moderate sensitivity)
• Theta: -0.378 (rapid time decay)
• Gamma: 0.0267 (high sensitivity to price swings)
• Turnover: 69,857
• Price Change: 800.00%
This call option offers explosive potential if Axsome sustains its rally. The high leverage ratio and gamma make it ideal for a continued bullish move, while moderate IV ensures cost efficiency. A 5% upside to $193.35 would yield a payoff of $8.35 per contract.

Top Option 2: AXSM20260116P175 (Put)
• Strike: $175, Exp: Jan 16, 2026
• IV: 38.63% (moderate)
• Leverage Ratio: 16.16% (moderate)
• Delta: -0.275 (moderate downside protection)
• Theta: -0.030 (slow time decay)
• Gamma: 0.0205 (moderate sensitivity)
• Turnover: 90,133
• Price Change: -58.57%
This put provides a hedge against a pullback, with moderate leverage and IV. If Axsome consolidates, the put’s delta and gamma offer downside protection. A 5% downside to $174.94 would yield a payoff of $0.06 per contract.

Hook: Aggressive bulls may consider AXSM20260116C185 into a breakout above $185, while cautious investors should use AXSM20260116P175 to lock in gains.

Backtest Axsome Therapeutics Stock Performance
The backtest of AXSM's performance following a 24% intraday increase from 2022 to now reveals a strategy that underperformed the benchmark. The strategy's CAGR was -19.98%, compared to the benchmark's CAGR of -20.01%, with an excess return of 0.03%. However, the strategy had a maximum drawdown of 0.00%, indicating it avoided any significant losses during the period.

Axsome’s Bullish Momentum: Key Levels and Next-Step Catalysts
Axsome’s 23.75% surge is a testament to its regulatory momentum and pipeline potential. The stock’s technicals and options activity suggest a continuation of the rally, with the PDUFA date for AXS-05 and the NDA submission for AXS-12 serving as critical near-term catalysts. While Amgen’s -0.3% dip highlights sector volatility, Axsome’s unique positioning in high-growth CNS markets makes it a standout. Investors should watch for a breakout above $185 or a pullback to $170. Position for a breakout above $185 or a pullback to $170 to capitalize on Axsome’s next phase of growth.