Capricor Plummets Over 34%—What's Behind the FDA's Rejection?

• CAPR shares collapsed to a 52-week low of $6.74 before rebounding to $7.52 amid a $3.88 price surge
• FDA issued Complete Response Letter (CRL) rejecting Deramiocel's BLA for DMD cardiomyopathy
• HOPE-3 trial data expected in Q3 2025 could reignite approval hopes by Q1 2026
• Intraday volatility spanned $1.94 between $6.74 lows and $8.68 highs, erasing $8.41 from its 2025 peak

Today’s plunge reflects a catastrophic regulatory setback for Capricor’s lead therapy, with shares plummeting from $11.40 to $7.52—the lowest close since March 2024. The FDA’s rejection upends months of anticipation following Priority Review designation, creating immediate uncertainty for the biotech’s commercialization timeline.

FDA Rejects Lead Therapy, Demands Additional Clinical Data
Capricor’s stock crashed after the FDA issued a Complete Response Letter (CRL) rejecting its Biologics License Application (BLA) for Deramiocel, its cell therapy for Duchenne muscular dystrophy (DMD)-associated cardiomyopathy. The FDA cited insufficient evidence of effectiveness and unresolved Chemistry, Manufacturing, and Controls (CMC) issues. While Capricor plans to resubmit data from its ongoing Phase 3 HOPE-3 trial—expected in Q3 2025—the delay creates a multi-quarter approval void. CEO Linda Marbán called the decision 'unexpected,' emphasizing the company’s adherence to prior FDA guidance during development. The setback slashes near-term revenue hopes for a therapy targeting 15,000 U.S. DMD patients, with the stock now trading at just 33% of its March 2025 peak.

Bearish Bias Dominates—Focus on Put Options and Technical Levels
• MACD: +0.0928 (bullish crossover potential)
• RSI: 47.68 (neutral)
• Bollinger Bands: Current price ($7.52) hugs lower band ($7.61)
• Key Resistance: 200-day MA ($11.45), 30-day resistance ($10.30)
• Support: 52-week low ($3.52), 30-day support ($10.17)

Technicals suggest a near-term consolidation between $7.00-$8.00, with traders eyeing the $10.17-$10.30 zone as critical resistance. The $CAPR20250718P7.5 put (volume: 4,170) stands out with a 172% implied volatility ratio and 10.02% leverage, offering 620% premium gains if the stock drops below $7.50 by mid-July. Its delta (-0.44) and gamma (0.206) amplify sensitivity to price swings. For longer-dated plays, the $CAPR20250919P7.5 put (volume: 8,757) offers 242% IV and 2.50% leverage, with theta (-0.016) eroding time decay slowly until September expiry. Both contracts benefit from high turnover and theta/Gamma profiles.

Payoff Example: If CAPR falls to $6.00 (5% drop), the July $7.5 put gains $1.50 intrinsic value—37.5% return on premium. Aggressive bears should target puts expiring in July-September, while bulls await HOPE-3 data before re-engaging.

Backtest Capricor Stock Performance
The CAPR ETF has demonstrated resilience following a significant intraday plunge of at least -34%. While the 3-day win rate is 47.35%, the 10-day win rate is slightly lower at 45.36%, indicating that short-term positive returns are more likely to occur after the initial shock. The 30-day win rate of 46.69% suggests that medium-term positive returns are also probable. The maximum return during the backtest period was 9.61%, which occurred on day 54, highlighting the potential for substantial recovery after a steep decline.

Deramiocel’s Fate Hinges on Q3 Data—Stay Defensive
Capricor’s stock faces a pivotal inflection point as investors await HOPE-3 trial results this fall. With the FDA demanding additional clinical evidence, traders must balance the therapy’s Orphan Drug and RMAT designations against execution risks. The biotech sector’s broader performance—led by Amgen (AMGN, -1.48%)—offers little solace, as regulatory scrutiny looms over late-stage programs. Watch for $7.00 support and $10.00 resistance as key technical anchors. Investors should prioritize cash preservation until clinical clarity emerges—this is a 'wait for data' story until Q3 2025.