Corcept Therapeutics Investigation Widens After Corrected CR
Corcept Therapeutics Investigation deepens after corrected FDA CRL revealed prior warnings and triggered law-firm probes that weigh on shares and approval.
KEY TAKEAWAYS
- Corrected FDA CRL said agency had warned multiple times not to submit the relacorilant NDA.
- Multiple law firms opened securities probes into whether Corcept misled investors on efficacy and FDA communications.
- The disclosures prompted a roughly 17% share decline and scrutiny of prior approval timetable.
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Corcept Therapeutics (CORT) faces a widening investigation after a corrected FDA Complete Response Letter (CRL) dated Jan. 28, 2026 revealed the agency had warned the company multiple times not to submit a new drug application (NDA) for relacorilant. The disclosures prompted several law-firm securities probes and a roughly 17.0% drop in the company’s shares.
Corrected CRL and Clinical Evidence
The corrected CRL disclosed that the FDA had repeatedly cautioned Corcept against filing the NDA, citing significant review issues and concerns about liver safety. This contrasts with the original CRL, disclosed on Dec. 31, 2025, which stated the agency could not reach a favorable benefit-risk assessment without additional evidence of effectiveness despite positive results from the GRACE pivotal trial and supportive data from the GRADIENT confirmatory study.
Relacorilant is a selective cortisol modulator designed to treat hypertension secondary to hypercortisolism, a condition related to Cushing’s syndrome. The GRACE trial met its primary endpoint, and GRADIENT provided confirmatory evidence. Corcept had previously said the NDA was progressing toward approval by the end of 2025 and projected the hypercortisolism franchise could generate $3 billion to $5 billion in annual revenue within three to five years.
Law-Firm Probes and Investor Impact
On Jan. 30, 2026, multiple law firms announced securities-law investigations into Corcept, focusing on whether the company misled investors about relacorilant’s efficacy, safety, commercial prospects, and its communications with the FDA. The day’s public sequence included an initial firm announcement at 10:13 a.m. ET, a report on the corrected CRL at 10:36 a.m., a second firm’s probe at 2:20 p.m., an expanded investigation at 3:28 p.m., and a follow-up at 8:32 p.m.
The sharp share decline following these developments heightened investor scrutiny of Corcept’s prior approval timetable and revenue guidance. The investigations center on the company’s public statements and disclosures related to the drug and its regulatory interactions.
