Corcept Therapeutics · Nasdaq: CORT · Relacorilant (hypercortisolism)

The 8-K says the FDA acknowledged that GRACE met its primary endpoint and that GRADIENT provided confirmatory evidence. It does not mention the letter's points on the enriched population and missing data, the second trial's missed endpoint, the liver-injury finding or the pre-submission warnings; the 10-K later reports GRADIENT's placebo comparison was not statistically significant.

The 8-K is dated Dec 31, 2025; the version of the letter the FDA published is signed “01/28/2026” [FDA · Jan 28 · p. 8]. The letter says “we are unable to conduct a final benefit risk assessment” [FDA · Jan 28 · p. 3]; the 8-K says “the Agency concluded it could not arrive at a favorable benefit-risk assessment for relacorilant without Corcept providing additional evidence of effectiveness” [8-K · Dec 31].

The 8-K names the trials; the letter numbers them. The 8-K says the FDA acknowledged “pivotal GRACE trial met its primary endpoint” [8-K · Dec 31]; the letter says “While CORT125134-455 met its primary endpoint, the analysis was conducted in a highly enriched population” [FDA · Jan 28 · p. 2]. The 10-K describes GRACE's design: “The GRACE trial had two parts.” [10-K · Feb 24] The 8-K does not mention the enriched population or missing data. [8-K · searched]

The 8-K says “data from the company’s GRADIENT trial provided confirmatory evidence” [8-K · Dec 31]. Of CORT125134-456 the letter says “the trial did not meet its primary efficacy endpoint” [FDA · Jan 28 · p. 2]. The 8-K does not mention a missed endpoint. [8-K · searched] The 10-K, of GRADIENT: “The comparison between those who received relacorilant and placebo was not statistically significant.” [10-K · Feb 24]

The letter says “relacorilant is associated with drug induced liver injury (DILI)” [FDA · Jan 28 · p. 3]. The 8-K does not mention liver injury, [8-K · searched] nor does the 10-K, [10-K · searched] which says “Relacorilant has been well-tolerated in all of its clinical trials.” [10-K · Feb 24]

The letter says the FDA told the company “to expect significant review issues if you were to submit your application” [FDA · Jan 28 · p. 3]; the 8-K quotes the CEO: “We are surprised and disappointed by this outcome” [8-K · Dec 31]. The 8-K does not mention the earlier warnings. [8-K · searched]

The FDA's letter says it raised concerns in pre-submission meetings on several occasions, including about the design of CORT125134-455, and told Corcept to expect significant review issues if it submitted. Corcept submitted in December 2024. Its 8-K quotes the CEO as 'surprised and disappointed'; the 8-K, 10-K and latest 10-Q do not mention the earlier warnings.

The letter says: “During the pre-submission meetings, we informed you on several occasions of our concerns about the adequacy of the clinical development program to assess the effect of relacorilant on hypertension in the intended population including the design of CORT125134-455, and to expect significant review issues if you were to submit your application” [FDA · Jan 28 · p. 3].

The 10-K says: “In December 2024, we submitted a New Drug Application” [10-K · Feb 24]. In its decision the letter says of CORT125134-455 that “the analysis was conducted in a highly enriched population” [FDA · Jan 28 · p. 2].

The company's 8-K quotes its CEO: “We are surprised and disappointed by this outcome” [8-K · Dec 31]. The 8-K does not mention the pre-submission concerns, [8-K · searched] nor do the 10-K or the 10-Q for the quarter ended June 30, 2026. [10-K · searched]

The FDA's letter says substantial evidence of effectiveness was not demonstrated, setting out problems with both phase 3 trials, and that relacorilant is associated with drug-induced liver injury.

The letter says: “As substantial evidence of effectiveness was not demonstrated we are unable to conduct a final benefit risk assessment” [FDA · Jan 28 · p. 3].

On the first phase 3 trial: “While CORT125134-455 met its primary endpoint, the analysis was conducted in a highly enriched population” [FDA · Jan 28 · p. 2], so that the observed effect “likely overestimates the treatment effect of relacorilant in the intended population” [FDA · Jan 28 · p. 2]. It calls the open-label estimate “unreliable given the large amount of missing data” [FDA · Jan 28 · p. 2], adding that “there was no control group” [FDA · Jan 28 · p. 2].

On the second, CORT125134-456, the letter says “the trial did not meet its primary efficacy endpoint” [FDA · Jan 28 · p. 2], and of the company's subgroup analysis that it “was not pre-specified in the statistical analysis plan” [FDA · Jan 28 · p. 3] and that “post-hoc analyses of a failed trial can be unreliable” [FDA · Jan 28 · p. 3].

On safety, the FDA “concluded that relacorilant is associated with drug induced liver injury (DILI)” [FDA · Jan 28 · p. 3]: “four cases were assessed as probable DILI due to relacorilant” [FDA · Jan 28 · p. 3].

The letter also records that “During the pre-submission meetings, we informed you on several occasions of our concerns” [FDA · Jan 28 · p. 3].

Corcept resubmitted on June 17, 2026, with additional analyses of the original data that the FDA asked for in April; the FDA's target date is Dec 17, 2026. The resubmission 8-K and the latest 10-Q do not mention the letter's liver-injury finding.

The letter says “A resubmission must fully address all the deficiencies listed in this letter” [FDA · Jan 28 · p. 6], and among them that “relacorilant is associated with drug induced liver injury (DILI)” [FDA · Jan 28 · p. 3].

The 10-Q says: “In April 2026, the FDA asked us to conduct additional analyses of the data included in our NDA” [10-Q · Jul 29]. The resubmission 8-K says “As requested by the FDA, the resubmission includes additional analyses of data included in the original NDA submission” [8-K · Jun 17]. Neither that 8-K nor the 10-Q for the quarter ended June 30, 2026 mentions liver injury. [8-K · searched]

The FDA “has assigned a Prescription Drug User Fee Act target date of December 17, 2026 to complete its review” [10-Q · Jul 29]. Not in this record: the Dec 30, 2025 letter as first issued, the FDA's April 2026 request, the resubmission itself, and Corcept's filings after Sep 23, 2026. [not in record]