Corcept Therapeutics Plunges 46% on FDA Rejection: A Regulatory Setback Sparks Market Turmoil

Summary
• Corcept Therapeutics (CORT) slumps 46.43% intraday, trading at $37.605 amid a $36–$39 range.
• FDA issues a Complete Response Letter for relacorilant, halting its path to approval for hypercortisolism.
• CEO Joseph Belanoff vows to challenge the decision, but shares remain under pressure.
• Turnover surges to 2.6 million shares, signaling heightened investor anxiety.

Corcept Therapeutics faces a seismic shift as the FDA’s rejection of its flagship drug relacorilant triggers a catastrophic selloff. The stock’s freefall reflects a regulatory hurdle that could delay market access and revenue, with the biotech sector watching closely for fallout.

FDA’s CRL Sparks Investor Panic
The FDA’s Complete Response Letter (CRL) for relacorilant, Corcept’s lead candidate for hypercortisolism, has ignited a 46.43% intraday plunge. Despite meeting primary endpoints in the GRACE trial and confirmatory data from GRADIENT, regulators demanded additional efficacy evidence to justify a favorable benefit-risk profile. This regulatory setback has shattered investor confidence, with the stock trading at a 52-week low of $36. The CRL effectively pauses commercialization timelines, forcing Corcept to engage in costly and time-consuming data resubmissions. CEO Joseph Belanoff’s defiant stance—‘I am confident we will find a way’—fails to offset the immediate market reaction, as investors price in the drug’s delayed approval and uncertain revenue potential.

Options Playbook: Capitalizing on Volatility and Technical Deterioration
• Technical Indicators: RSI at 31.65 (oversold), MACD -0.24 (bearish), 200-day MA at $74.04 (far above current price).
• Key Levels: Immediate support at $36 (52W low), resistance at $39 (intraday high).
• Options Chain Analysis:
- CORT20260116P37: Put option with strike $37, expiration 2026-01-16. IV: 80.71% (high volatility), leverage ratio: 14.43%, delta: -0.4649 (moderate sensitivity), theta: -0.0271 (low time decay), gamma: 0.0618 (high sensitivity to price swings). Turnover: 7,627 contracts. This put offers asymmetric upside in a 5% downside scenario (projected price: $35.72), yielding a $1.28 payoff per contract.
- CORT20260116P35: Put option with strike $35, expiration 2026-01-16. IV: 88.57% (extreme volatility), leverage ratio: 19.96%, delta: -0.3493 (moderate sensitivity), theta: -0.0409 (moderate time decay), gamma: 0.0524 (high sensitivity). Turnover: 68,455 contracts. This put thrives in a 5% downside scenario, with a $1.90 payoff per contract.

Both options exploit Corcept’s technical breakdown and elevated volatility. The CORT20260116P37 balances moderate delta with high gamma, ideal for a short-term bearish bet. The CORT20260116P35, despite higher IV, offers superior leverage and liquidity, making it a robust hedge against further declines. Aggressive short-sellers should prioritize these puts as the stock tests $36 support.

Backtest Corcept Therapeutics Stock Performance
The performance of CORT after a -46% intraday plunge from 2022 to now has shown positive returns in various time frames. The backtest results indicate a 3-day win rate of 58.81%, a 10-day win rate of 59.07%, and a 30-day win rate of 67.36%. Additionally, the maximum return during the backtest period was 14.92%, with a maximum return day at 59.

Regulatory Hurdles and a Path Forward: What to Watch Now
Corcept’s 46% collapse underscores the fragility of its relacorilant thesis, with the FDA’s CRL casting a long shadow over its hypercortisolism program. While the company’s pivot to platinum-resistant ovarian cancer (PDUFA July 2026) offers a lifeline, near-term focus remains on its ability to resubmit data and secure a revised approval timeline. Investors should monitor the $36 support level and the FDA’s response to Corcept’s resubmission strategy. Meanwhile, the biotech sector’s leader, Amgen (AMGN), remains stable with a 0.0867% intraday gain, highlighting the sector’s resilience to isolated setbacks. For CORT, the path forward hinges on regulatory agility and investor sentiment—a volatile mix demanding close scrutiny. Watch for a breakdown below $36 or a catalyst-driven rebound above $39 to gauge the stock’s next move.