Corcept Therapeutics Faces FDA Rejection for Relacorilant, Stock Crashes 50% as Regulatory Risk Materializes

What happened

Corcept Therapeutics received an FDA Complete Response Letter for relacorilant on December 31, 2025, triggering a 50% stock plunge and investor scrutiny. This event directly contradicts the company's late-stage diversification hopes, which were central to its growth narrative as outlined in prior analyses. Previously, Corcept maintained profitability through its Korlym franchise, but its elevated valuation relied heavily on relacorilant's approval to mitigate single-asset risks. The CRL has now prompted an investigation by Hagens Berman into potential investor misrepresentations, adding legal overhangs. This outcome validates the binary regulatory warnings in the DeepValue report, shifting the investment landscape from cautious optimism to heightened uncertainty.

Implication

The CRL for relacorilant eliminates a key near-term catalyst, severely undermining Corcept's pipeline diversification and leaving it dependent on Korlym, which faces generic erosion and reimbursement headwinds. Corcept must now navigate FDA resubmission hurdles, likely delaying commercialization and escalating R&D costs without assured success, further straining financials. With the investigation by Hagens Berman, investors face additional legal and reputational risks that could amplify losses and erode trust in management's disclosures. The stock's previous premium valuation, based on relacorilant's potential, is now unjustified, necessitating a downgrade to account for diminished growth prospects. Investors should brace for continued volatility and potential downside as the company grapples with these compounded challenges.

Thesis delta

The FDA's Complete Response Letter for relacorilant represents a decisive negative shift, moving the investment stance from HOLD/NEUTRAL to SELL. This event invalidates the anticipated regulatory approval catalyst that supported the prior thesis, aligning with the report's warning that a CRL would skew to SELL. Investors must now confront heightened risks, including stalled pipeline progress and increased reliance on a core business under pressure.