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

• 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

• What pushes it up. Corcept Therapeutics resubmitted the NDA on 17 June 2026 and expects a six‑month review, targeting a decision around 17 Dec 2026, indicating progress toward approval [tier 1]
• What pushes it down. The FDA issued a Complete Response Letter on 31 Dec 2025 citing insufficient primary‑endpoint and confirmatory data, and historically only 64% of such resubmissions succeed [base rate]
• What pushes it down. No new pivotal trial data or additional evidence has been publicly disclosed, leaving uncertainty about whether FDA concerns are fully addressed [tier 1]
• What would move this number most. Whether the additional data submitted with the resubmission adequately resolves the FDA's concerns about efficacy and benefit‑risk

• What pushes it up. Base rate for NMEs after a CRL is 64%, indicating a majority eventually receive approval [tier 1 reference to the verified base‑rate study]
• What pushes it up. Corcept has resubmitted the NDA and the FDA has set a six‑month review target, showing the agency is actively processing the application [tier 1 press release]
• What pushes it down. The FDA issued a Complete Response Letter citing insufficient primary‑endpoint data, which historically lowers approval odds [tier 1 press release]
• What pushes it down. Only tier‑4 reports describe new data, providing weak evidence that the concerns have been fully addressed [tier 4 articles 10,11,12]
• What would move this number most. Whether the new data submitted will satisfy the FDA’s concerns about the primary endpoint and overall benefit‑risk profile

• What pushes it up. Resubmission of the NDA with new data and a six‑month review timeline indicates FDA is proceeding toward a decision (tier 1)
• What pushes it down. The original CRL cited insufficient primary‑endpoint and confirmatory data, a serious shortfall that historically lowers approval odds (tier 1)
• What pushes it down. Reliance on tier‑4 leak articles for the new data adds uncertainty (tier 4)
• What would move this number most. Whether the additional data submitted will satisfy the FDA’s concerns about efficacy and benefit‑risk

• What pushes it up. Corcept resubmitted the NDA on June 17, 2026 following the Complete Response Letter, indicating new data analyses were submitted to address FDA concerns [tier 1 starting state, tier 4].
• What pushes it down. The CRL was triggered by clinical trial efficacy concerns regarding the GRACE and GRADIENT trials, which are typically harder to resolve quickly without a new trial than manufacturing issues [tier 1 starting state, tier 3].
• What pushes it down. The expected 6-month PDUFA review target date around December 17, 2026 leaves virtually no margin for error; any minor extension or slight delay past December 17, 2026 would cause a NO resolution [tier 1 starting state].
• What would move this number most. Whether the FDA considers the resubmitted data/analyses from existing trials sufficient without requiring a new clinical trial, and whether the review is completed on or before the December 17, 2026 deadline.

• What pushes it up. Corcept resubmitted the NDA on 17 June 2026 with additional data, securing a standard six-month review clock with a target action date of 17 December 2026 [tier 1 state / tier 4 article 5].
• What pushes it up. Historically, a majority of resubmitted drug applications following a Complete Response Letter eventually gain FDA approval [tier 1 base rate].
• What pushes it down. The CRL issued on 31 December 2025 was due to clinical efficacy and benefit-risk assessment concerns from the GRACE and GRADIENT trials, which are generally harder to resolve quickly than manufacturing issues [tier 1 state / tier 3 article 7].
• What pushes it down. The target action date falls on the exact deadline date of 17 December 2026, meaning any minor review extension or postponement by the FDA automatically results in a NO resolution [tier 1 state].
• What would move this number most. Whether the FDA accepts the supplemental analyses submitted without requiring a new full clinical trial, and whether the decision is issued on or before the 17 December 2026 target action date without extensions.

• What pushes it up. The resubmitted NDA was accepted for review on 17 June 2026, establishing a clear PDUFA target date of 17 December 2026, which aligns exactly with the resolution deadline [tier 4].
• What pushes it down. The initial CRL was issued because the FDA deemed the GRACE trial's primary endpoint and GRADIENT confirmatory data insufficient for a favorable benefit-risk assessment, indicating significant regulatory hurdles that may not be fully resolved by the resubmission [tier 1 context].
• What would move this number most. Whether the additional evidence provided in the June 2026 resubmission sufficiently addresses the FDA's specific concerns regarding the benefit-risk profile of the GRACE and GRADIENT trial data.

Reasons not recorded for this revision (detailed history has only been kept since recently).

Reasons not recorded for this revision (detailed history has only been kept since recently).