Two law firms probe Corcept Therapeutics after FDA issues relacorilant Complete Response Letter

Headline: Two law firms open probes into Corcept over relacorilant FDA response

Main inquiry into corporate disclosures

Two U.S. securities firms announce parallel investigations into Corcept Therapeutics after the company discloses a Complete Response Letter (CRL) from the U.S. Food and Drug Administration for its relacorilant New Drug Application. DJS Law Group and the Schall Law Firm say they are examining whether Corcept made false or misleading statements or failed to disclose material information surrounding the FDA’s decision on relacorilant for hypertension secondary to hypercortisolism. Both firms frame their probes as focused on potential securities law violations tied to the timing and content of Corcept’s public disclosures.

The firms note the CRL acknowledges that Corcept’s pivotal GRACE trial meets its primary endpoint and that data from the GRADIENT trial provide confirmatory evidence, but that the FDA states it cannot arrive at a favorable benefit‑risk assessment without additional evidence of effectiveness. The investigators say their reviews will center on the apparent disconnect between the agency’s recognition of positive trial outcomes and its request for more evidence, assessing whether Corcept adequately communicated the scope and implications of the CRL to investors and regulators.

DJS and Schall outline the documentary and testimonial sources they intend to probe, including public statements, SEC filings, investor presentations and the timing of disclosures to determine executives’ knowledge of adverse evidence. Each firm invites shareholders who believe they suffered losses to come forward for potential representation, and both signal that any resulting litigation would seek to address whether omissions or misstatements deprived investors of material information about Corcept’s regulatory pathway for relacorilant.

Law firms’ outreach and disclosures

Both law firms include contact information and note their specialties in securities class actions and shareholder rights litigation; DJS Law Group provides a Los Angeles office notice and emphasizes its global representation of hedge funds and alternative asset managers, while Schall offers contingency representation and free consultations. Each release contains attorney‑advertising language and encourages affected shareholders to engage promptly for initial assessments.

Regulatory and industry context

The FDA’s request for additional effectiveness data highlights regulatory scrutiny specific to therapies targeting glucocorticoid receptor pathways and treatments for conditions tied to hypercortisolism. For Corcept and peers developing modulators like relacorilant, the agency’s stance underscores the need for robust confirmatory evidence beyond primary endpoints to satisfy benefit‑risk evaluations in complex endocrine and cardiovascular indications.