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Will the FDA approve relacorilant for hypercortisolism (Cushing's syndrome)?

deadline 2026-12-17 confidence medium tier 1 evidence
45%Asturna estimate

Resolution criterion

Resolves YES if the FDA publishes an approval (Drugs@FDA or an official Corcept Therapeutics press release) for relacorilant in hypertension secondary to hypercortisolism (Cushing's syndrome) on or before 17 December 2026. A further complete response letter, a postponement of the PDUFA date, or the absence of a decision count as no.

Verified starting state

Received a Complete Response Letter on 31 December 2025 — the FDA judged the GRACE trial's primary endpoint and GRADIENT confirmatory data insufficient for a favorable benefit-risk assessment without additional evidence. Corcept resubmitted the NDA on 17 June 2026 and expects a six-month review, placing the target action date around 17 December 2026. (Corcept Therapeutics press releases, 31 December 2025 and 17 June 2026)

What pushes it up

What pushes it down

What would move this number most

Whether Corcept's re-analyzed or supplemental clinical data satisfied the FDA's efficacy concerns without triggering a three-month review extension or a second CRL.

How this number is built

Deadline2026-12-17
Base rate64%
Best evidencetier 1 · 4 article(s) used
Independent runs42 · 48 (spread 6 pts)
Confidencemedium
Evidence capnot triggered
Last revised2026-10-18 09:08
Modelgemini-3.7-flash

Sources consulted

FDA Rare Disease Innovation Hubtier 1 · FDA · 2026-10-14FDA Rare Disease Framework Initiative Public Meeting - 10/28/2026tier 1 · FDA · 2026-10-14FDA ‘reset’ continues with new plan for reviewing rare disease drugstier 4 · BioPharma Dive · 2026-10-15FDA Launches the Rare Disease Framework Initiative to Develop a Holistic, Fit-For-Purpose Framework for Rare Disease Drug Developmenttier 4 · U.S. Food and Drug Administration (.gov) · 2026-10-14

Probability history

2026-10-18 09:08 45% 96 article(s) on file · gemini-3.7-flash
  • What pushes it up. The FDA accepted the NDA resubmission on 17 June 2026 under a standard six-month review timeline [tier 1].
  • What pushes it up. The FDA continues to actively emphasize regulatory flexibility in rare disease settings, as highlighted by initiatives like the Rare Disease Framework Initiative launched in October 2026 [tier 1].
  • What pushes it down. The CRL cited insufficient primary endpoint and confirmatory data for a favorable benefit-risk profile, a clinical hurdle that is difficult to overturn without new clinical trials [tier 1].
  • What pushes it down. Corcept resubmitted within less than six months of the CRL, indicating reliance on existing data re-analyses rather than new pivotal study data, which carries higher regulatory skepticism [tier 1].
  • What pushes it down. The resolution deadline strictly coincides with the estimated PDUFA date of 17 December 2026; any review postponement, major amendment adding three months, or administrative delay automatically counts as a negative resolution [tier 1].
  • What would move this number most. Whether Corcept's re-analyzed or supplemental clinical data satisfied the FDA's efficacy concerns without triggering a three-month review extension or a second CRL.
2026-10-17 09:10 56% 90 article(s) on file · gemini-3.7-flash
  • What pushes it up. Corcept resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review window placing the target action date right at mid-December 2026 [tier 1].
  • What pushes it up. Base rate of approvals post-CRL for NMEs provides a solid historical baseline of 64% [tier 1].
  • What pushes it down. The CRL cited clinical efficacy and benefit-risk balance concerns across the GRACE and GRADIENT trials, which are significantly harder to overcome without a new prospective trial than quality or manufacturing deficiencies [tier 1].
  • What pushes it down. The resolution criteria require approval on or before 17 December 2026; any review postponement, standard 3-month major amendment extension, or second CRL results in a NO resolution [tier 1].
  • What would move this number most. Whether the resubmission addressed the clinical benefit-risk concerns to FDA satisfaction without new phase 3 trial data, and whether the FDA reaches a decision on or before the 17 December 2026 cutoff without extending review.
2026-10-16 20:07 50% 90 article(s) on file · gemini-3-flash-preview
  • What pushes it up. Corcept Therapeutics resubmitted the NDA on 17 June 2026, indicating they believe the additional evidence provided addresses the FDA's previous concerns [1].
  • What pushes it up. The FDA launched a 'Rare Disease Framework Initiative' and 'Rare Disease Innovation Hub' in October 2026, signaling a potentially more supportive regulatory environment for orphan indications like Cushing's syndrome [1, 2, 28].
  • What pushes it down. The initial CRL (31 December 2025) was based on clinical data insufficiency in the primary trials (GRACE and GRADIENT), which is generally more difficult to resolve than manufacturing issues [1].
  • What pushes it down. The resolution deadline (17 December 2026) coincides exactly with the expected 6-month PDUFA date; any minor delay or a standard 3-month extension would result in a 'No' resolution [1].
  • What pushes it down. The relatively short time (5.5 months) between the CRL and resubmission suggests the 'additional evidence' may rely on re-analysis or existing data rather than new long-term clinical trials [1].
  • What would move this number most. Whether the specific 'additional evidence' submitted in June 2026 successfully overcomes the FDA's previous judgment that the benefit-risk assessment was unfavorable based on the GRACE and GRADIENT trials.
2026-10-14 09:08 56% 76 article(s) on file · gemini-flash-latest
  • What pushes it up. Corcept Therapeutics successfully resubmitted the relacorilant NDA on 17 June 2026, which was accepted for a standard six-month Class 2 review with a target action date of 17 December 2026 [tier 1].
  • What pushes it up. Relacorilant addresses a critical unmet need in Cushing's syndrome as a selective cortisol modulator without progesterone receptor activity [tier 1].
  • What pushes it down. The initial CRL cited fundamental efficacy and benefit-risk deficits across both the GRACE and GRADIENT studies, issues that are difficult to resolve within six months without generating new clinical trial data [tier 1].
  • What pushes it down. The resolution deadline of 17 December 2026 leaves zero calendar buffer: any standard three-month PDUFA extension for major amendments, advisory committee input, or administrative delay past that exact date resolves the question as NO [tier 1].
  • What would move this number most. Whether the FDA accepts Corcept's re-analyses and additional data without requiring a new prospective trial, and whether the review concludes strictly within the six-month window without an extension.
2026-10-13 12:04 54% 76 article(s) on file · gemini-3-flash-preview
  • What pushes it up. Corcept Therapeutics resubmitted the NDA for relacorilant on 17 June 2026, indicating they have provided the additional evidence requested by the FDA [1].
  • What pushes it up. The target action date (PDUFA) is expected around 17 December 2026, which aligns with the resolution deadline [1].
  • What pushes it down. The initial CRL was based on 'insufficient evidence' for a favorable benefit-risk assessment from two trials (GRACE and GRADIENT), which is a more difficult hurdle to overcome than manufacturing or labeling issues [1].
  • What pushes it down. The resolution criterion is highly sensitive to timing; any delay beyond the PDUFA date, such as the review extensions recently seen with other manufacturers, would result in a NO [2].
  • What pushes it down. The relatively short 6-month turnaround for resubmission suggests the company may be relying on re-analysis of existing data rather than new clinical trials, which the FDA may still find insufficient [1].
  • What would move this number most. The primary uncertainty is whether the 'additional evidence' provided in the June 2026 resubmission is robust enough to reverse the FDA's previous judgment that the trial data was insufficient for a favorable benefit-risk assessment.
2026-10-12 12:01 56% 67 article(s) on file · gemini-flash-latest
  • What pushes it up. Corcept resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review, aligning the target action date around 17 December 2026 [tier 1].
  • What pushes it down. The CRL on 31 December 2025 specifically cited insufficient benefit-risk based on the GRACE and GRADIENT trials without additional evidence; resubmitting in less than six months means no new prospective trial could have been completed to satisfy the FDA [tier 1].
  • What pushes it down. Any standard three-month PDUFA extension or administrative postponement beyond 17 December 2026 automatically resolves the question as NO under the resolution criteria [tier 1].
  • What would move this number most. Whether the FDA accepts Corcept's re-analyses and existing clinical evidence without demanding a new prospective trial, and whether a decision is issued without a PDUFA extension.
2026-10-11 09:14 56% 67 article(s) on file · gemini-3.7-flash
  • What pushes it up. Corcept successfully resubmitted the NDA on 17 June 2026 with an expected six-month Class 2 review period targeting action around 17 December 2026 [tier 1].
  • What pushes it down. The initial CRL cited core clinical efficacy and benefit-risk insufficiency from the GRACE and GRADIENT trials, which is substantially harder to resolve within 5.5 months without a new prospective trial than CMC or manufacturing deficiencies [tier 1].
  • What pushes it down. The target PDUFA date falls directly on the deadline of 17 December 2026; any standard three-month review extension, postponement, or slight timing slip resolves the question as NO under the resolution rules [tier 1].
  • What would move this number most. Whether Corcept's re-analyses of existing GRACE and GRADIENT data satisfy the FDA's clinical efficacy concerns without requiring new prospective trial data, and whether the review concludes on or before the strict 17 December deadline without extension.
2026-10-08 09:14 54% 50 article(s) on file · gemini-3-flash-preview
  • What pushes it up. Corcept resubmitted the NDA on June 17, 2026, following a CRL, indicating they believe they have addressed the FDA's concerns regarding trial data [1].
  • What pushes it up. The FDA accepted the resubmission for a six-month Class 2 review, suggesting the package was complete enough for a standard turnaround [1].
  • What pushes it up. Corcept has significant experience in this therapeutic area, having previously secured approval for Korlym (mifepristone) for Cushing's syndrome [1].
  • What pushes it down. The initial CRL was based on 'insufficient evidence' for the primary endpoint in the GRACE trial and GRADIENT confirmatory data, which is a significant clinical hurdle to overcome without new trials [1].
  • What pushes it down. The PDUFA target action date (Dec 17, 2026) coincides exactly with the resolution deadline, meaning any minor delay or a standard three-month extension would result in a 'No' resolution [12, 28].
  • What pushes it down. The resolution criterion explicitly states that a postponement of the PDUFA date counts as a 'No', and such extensions are common in complex regulatory reviews [12, 28].
  • What pushes it down. FAERS reports 3 serious safety signals for relacorilant, which may complicate the benefit-risk assessment during the final review phase [Context].
  • What would move this number most. Whether the 'additional evidence' provided in the resubmission was new clinical data or just a re-analysis of the GRACE/GRADIENT trials; a re-analysis is less likely to satisfy the FDA's previous concerns about 'insufficient evidence'.
2026-10-03 09:04 64% 28 article(s) on file · qwen/qwen3.8-27b (Groq)
  • What pushes it up. The NDA was successfully resubmitted on 17 June 2026, indicating that Corcept addressed the FDA's specific data deficiencies regarding the GRACE and GRADIENT trials [1].
  • What pushes it down. The initial CRL on 31 December 2025 cited insufficient primary endpoint and confirmatory data, suggesting a high hurdle for the resubmission to be accepted without further delay [1].
  • What would move this number most. Whether the additional evidence provided in the June 2026 resubmission is sufficient to overcome the FDA's previous determination that the benefit-risk assessment was unfavorable.
2026-10-02 09:09 58% 26 article(s) on file · openai/gpt-oss-120b (Groq)
  • What pushes it up. Resubmission of the NDA on 17 June 2026 shows Corcept has added data and the FDA has set a six‑month review window, indicating progress toward a decision [tier 1]
  • What pushes it up. Historical post‑CRL approval rate above 50 % suggests a better‑than‑even chance [tier 1]
  • What pushes it down. The FDA’s CRL on 31 Dec 2025 cited insufficient primary‑endpoint and confirmatory data, a strong negative signal [tier 1]
  • What pushes it down. Only a six‑month review remains; any delay would push the decision past the 17 Dec 2026 deadline, reducing the chance of approval in time [tier 1]
  • What pushes it down. Safety signals (3 serious FAERS reports) add regulatory caution, even if not decisive [context only]
  • What would move this number most. Whether the additional evidence submitted on 17 June 2026 will satisfy the FDA’s concerns about efficacy and benefit‑risk