MoonLake aumentó en un 22% debido al permiso de la FDA para presentar el informe de evaluación de seguridad. Los analistas reafirman su perspectiva alcista.

Summary
• MoonLake Immunotherapeutics (MLTX) surges 27.3% to $18.26, defying a 52-week low of $5.95
• FDA confirms sonelokimab’s Biologics License Application (BLA) path for hidradenitis suppurativa
• BTIG upgrades MLTX to Buy with $24 price target, citing de-risked regulatory timeline

MLTX’s 27.3% intraday rally has ignited speculation about its regulatory turnaround. The stock’s surge follows a pivotal FDA Type B meeting, which validated sonelokimab’s clinical data for hidradenitis suppurativa (HS) without requiring additional trials. With a 52-week high of $62.75 still distant, the move reflects a mix of regulatory optimism and market skepticism about the company’s cash burn and execution risks.

FDA Clears Path for Biologics License Application
MoonLake’s dramatic 27.3% intraday jump stems from the FDA’s confirmation that sonelokimab’s existing clinical data package—encompassing the VELA and MIRA trials—provides 'substantial evidence of effectiveness' for hidradenitis suppurativa (HS). This regulatory validation eliminates the need for further trials, accelerating the BLA submission to H1 2026. The decision transforms sonelokimab from a 'mixed' clinical asset to a high-conviction regulatory play, reigniting M&A speculation and institutional buying. Analysts at BTIG and Clear Street have raised price targets to $24–$45, citing the drug’s potential to capture a $10B HS market by the mid-2030s.

Options Playbook: High-Leverage Calls and Volatility-Driven Puts
• MACD: -0.415 (bearish divergence), RSI: 52.7 (neutral), Bollinger Bands: $11.06–$15.81 (oversold)
• 200D MA: $34.37 (far above current price), 30D MA: $13.62 (support level)

MLTX’s technicals suggest a short-term bullish trend amid long-term bearish pressure. The stock is trading near its 30D MA ($13.62) but remains 30% below its 200D MA, indicating a volatile, overextended position. High implied volatility (IV) in the options chain—peaking at 132% for February 2026 contracts—reflects market uncertainty about the BLA timeline and cash burn risks.

Top Options Contracts:
• MLTX20260116C17.5 (Call, $17.5 strike, Jan 16):
- IV: 97.3% (high volatility)
- Leverage Ratio: 12.07% (moderate)
- Delta: 0.658 (moderate sensitivity)
- Theta: -0.116 (rapid time decay)
- Gamma: 0.1389 (high sensitivity to price swings)
- Turnover: $240,809 (liquid)
- Payoff (5% upside): $1.67 per contract (18.26 → 19.17)
- Why it stands out: High gamma and IV make this call ideal for a short-term rally, with liquidity to manage entry/exit.

• MLTX20260116C20 (Call, $20 strike, Jan 16):
- IV: 108.9% (extreme volatility)
- Leverage Ratio: 30.08% (aggressive)
- Delta: 0.327 (low sensitivity)
- Theta: -0.095 (moderate time decay)
- Gamma: 0.122 (high sensitivity)
- Turnover: $108,888 (liquid)
- Payoff (5% upside): $0.91 per contract (18.26 → 19.17)
- Why it stands out: High leverage and IV suit aggressive bulls betting on a continued rally, though delta suggests limited downside protection.

Trading Setup: Aggressive bulls may consider MLTX20260116C17.5 into a break above $18.50, while cautious traders could use MLTX20260116C20 for a high-leverage play on a $24 target. Monitor the $14.92 intraday low as a critical support level; a break below could trigger a retest of the 52-week low.

Backtest MoonLake Stock Performance
The backtest of MLTX's performance following a 27% intraday surge from 2022 to the present indicates positive short-to-medium-term gains. The 3-Day win rate is 51.48%, the 10-Day win rate is 55.93%, and the 30-Day win rate is 68.22%, suggesting a higher probability of positive returns in the immediate aftermath of such a surge. The maximum return during the backtest was 23.38% over 30 days, indicating that MLTX can continue to perform well in the medium term after an initial significant increase.

MoonLake at Inflection Point: Watch for $24 Target and Sector Catalysts
MoonLake’s 27.3% intraday surge reflects a regulatory inflection point, but sustainability hinges on its ability to maintain momentum above $18.50 and execute a successful BLA submission. The stock’s technicals suggest a volatile path ahead, with the 200D MA ($34.37) remaining a distant target. Investors should watch the February 23 investor day and February 26 earnings report for clarity on cash burn and development timelines. Meanwhile, sector leader Amgen (AMGN) fell 1.39% today, underscoring biotech sector fragility. For MLTX, the $24 BTIG target offers a 33% upside, but execution risks and cash constraints remain critical hurdles. Action: Buy MLTX20260116C17.5 if $18.50 holds; exit if $14.92 breaks.