Corcept Therapeutics Incorporated ($CORT) Misleading FDA Approval Prospects for Relacorilant Case

Investors can submit applications for the lead plaintiff role.

N.D. California

Court

3:26-cv-01525

Case number

10/31/2024

Class period Start

12/30/2025

Class period End

04/21/2026

Lead Plaintiff motion deadline

$CORT investors filed a claim against Corcept Therapeutics Incorporated for allegedly misleading investors about the strength of the clinical evidence supporting its relacorilant New Drug Application (NDA) and the likelihood of FDA approval.
After Corcept disclosed it received an FDA Complete Response Letter (CRL) and that the FDA could not reach a favorable benefit-risk assessment without additional evidence of effectiveness, $CORT fell 50.4% on December 31, 2025.
$CORT investors can join this case to be notified about potential recovery.
Case Details:

Between October 31, 2024 and December 30, 2025, Corcept told investors that key clinical trial results for relacorilant in hypercortisolism (Cushing’s syndrome) were “powerful support” for its NDA and that it had communicated with the FDA and foresaw no impediments to approval—later emphasizing that “relacorilant is approaching approval” and that approval was expected by year-end.

However, during this period, investors allege the FDA had repeatedly raised concerns about the adequacy of the clinical evidence supporting the relacorilant NDA and warned Corcept to expect significant review issues, creating a known material risk that the NDA would not be approved. Corcept allegedly failed to disclose these FDA concerns and related approval risk to the market.

Then, on December 31, 2025, the company revealed that the FDA issued a CRL regarding the relacorilant NDA, stating it could not reach a favorable benefit-risk assessment without Corcept providing additional evidence of effectiveness. The stock fell $35.40 per share (50.4%), closing at $34.80.

Additional revelations followed on January 30, 2026, when the FDA published a redacted copy of the CRL detailing its concerns and stating that, during pre-submission meetings, the FDA informed Corcept “on several occasions” about concerns regarding the adequacy of the clinical development program and warned the Company to expect significant review issues if it submitted the application.

By December 31, 2025, shares had fallen to $34.80, representing a 50.4% decline from the correction period.

Based on these events, $CORT investors filed a claim against Corcept Therapeutics Incorporated, alleging the company:
It misrepresented that the relacorilant trial results provided “powerful support” for the NDA and overstated the likelihood/timing of FDA approval
It failed to disclose that the FDA had repeatedly raised concerns about the adequacy of the clinical evidence and warned of significant review issues
It misled investors about Corcept’s regulatory outlook for relacorilant, inflating $CORT’s stock price until the CRL disclosure
Investors argue Corcept misled the market about the strength of the relacorilant NDA and the true risk of non-approval, causing losses when the FDA’s CRL revealed the alleged issues.

Case Type

US Securities Class Action

Case Status

Lead Plaintiff Submission

Alleged Offence

Misleading Statements,

Financial Misrepresentation,

Fraud,

Failure to Disclose

Suspected Party

Management

Security Type

Stocks

Trade Direction

Long

Shock Event Date

12/31/2025

Filing date

02/20/2026

Lead Plaintiff Deadline

04/21/2026

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