Registered forecast
45% registered probability event by 2026-12-17 Unresolved
FDA approves relacorilant for Cushing's syndrome (resubmission) on or before the disclosed PDUFA goal date of 2026-12-17
FF-034 Registered - Registered probability
- 45%
- Event by
- 2026-12-17
- Resolution window
- 2026-10-16 → 2026-12-17
- Target rung
- 5 Guideline
- 6 Regulatory
- 7 Coverage
- Baselines it has to beat
-
- Authority base rate 50%
- Calendar cycle 60%
- Analyst proxy 45%
nextconsensus.com/forecast/ff-034/ registry snapshot 2026-10-15 Share image
NextConsensus registered this probability on 2026-10-15. It is one of 26 registered FDA goal-date forecasts.
The proposition
What was claimed
The FDA takes an approval action on Corcept Therapeutics' resubmitted New Drug Application for relacorilant for the treatment of patients with Cushing's syndrome (endogenous hypercortisolism), with an approval action date on or before 2026-12-17, the PDUFA date disclosed in Exhibit 99.1 to Corcept's Form 8-K filed 2026-07-29.
- Authority
- US Food and Drug Administration (FDA), Center for Drug Evaluation and Research (CDER) (US)
- Target rungA step on the 12-rung ladder: rungs 1 to 4 are the evidence moving, rungs 5 to 7 are a guideline body, regulator, or payer acting. The ladder, rung by rung
- Rung 6: Regulatory action — Label/indication change, approval action, REMS modification, or withdrawal by FDA, EMA, PMDA, Health Canada, etc.
- Forecast classThe group of like forecasts this one is counted and scored with, such as FDA actions by their goal dates
- FDA action by goal date
- Scope
- Cushing's syndrome (endogenous hypercortisolism)
The estimate
The number and the baselines it has to beat
The alternatives it was registered against, each with the reasoning that produced it.
ESTIMATE FROM THE SHAPE OF THE CLASS, NOT AN ENUMERATED COUNT. Resubmissions after a complete response letter are approved on the next cycle about as often as not, depending on whether the deficiency was evidence or process. The calendar's own count does not exist yet.
A clock-only model: FDA meets most resubmission goal dates, and a second cycle that answers the letter's request is often approved.
An endocrine-focused analyst reading the same filings on 2026-10-01 would weigh a complete response letter that asked for more evidence of efficacy against a resubmission built on analyses FDA itself requested, and would call the second cycle roughly even. Estimated by reconstructing that read, not by surveying analysts.
Regulatory action (FDA): offered on judgment, with no calibration figure until 15 in the class have resolved.
The clock
Dates that constrain the record
- Evidence cutoff
- 2026-10-15
Nothing after this date informed the estimate. - Registered
- 2026-10-15
Frozen and hashed. - Resolution window
- 2026-10-16 → 2026-12-17
When the adjudicator can read the outcome. - Event by
- 2026-12-17
The final qualifying action date; the frozen resolution rule defines what counts. Add to calendar
fc3ac1610959707a4812d77bb108b55de1f4cd352bd231e60d6d3408aec5ddf8 · operator record jc-1792036248696-ed4247ab
Around this record
- This kind of deadline
- Check it, follow it
Single-claim evaluation
Waiting on the FDA for an asset of your own?
Name the claim, who decides it, and the date your team commits to: a P&T meeting, an HTA submission, a label negotiation, a deal closing. Yours is registered under the same rules as the forecast on this page.
Resolution
The rule that settles the forecast
Relacorilant was already approved for another indication at the cutoff: openFDA lists NDA220641 (LIFYORLI, platinum-resistant ovarian cancer), ORIG 1 approved 2026-03-25 (SRC-005). The Cushing's application is identified by its indication, not by application number. Resolves YES if the openFDA Drugs@FDA records returned by https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100 and by https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, read together, contain a submission, original or supplement, with submission_status AP and a submission_status_date on or before 2026-12-17, and the Drugs@FDA approval letter or label for that submission names Cushing's syndrome or endogenous hypercortisolism (including a sign of it such as hyperglycaemia or hypertension secondary to hypercortisolism) in its indication, with Corcept or a Corcept subsidiary as applicant. An approval for a narrower Cushing's syndrome population, or for one manifestation of hypercortisolism, still resolves YES. Resolves NO if no approval action is dated on or before 2026-12-17: a complete response letter, a goal-date extension, withdrawal or no action. The goal date is frozen as disclosed at the cutoff; a later extension does not move it, and an approval dated after 2026-12-17 resolves NO as occurred_after_deadline. Read no earlier than 2026-12-31. If openFDA has not refreshed by then, the Drugs@FDA web record (https://www.accessdata.fda.gov/scripts/cder/daf/, searched by the name relacorilant) governs. Resolves unresolvable only if none of these sources can be read after the read floor. Resolves VOID, with the reason recorded, only if FDA withdraws every public record of approval actions named above without an equivalent public successor, so that no approval date for this product can be read; while any of them publishes it, the rule stands.
Source the rule names: https://api.fda.gov/drug/drugsfda.json?search=openfda.generic_name:%22relacorilant%22&limit=100, https://api.fda.gov/drug/drugsfda.json?search=products.active_ingredients.name:%22RELACORILANT%22&limit=100, https://www.accessdata.fda.gov/scripts/cder/daf/
Readers: Resolver A, clinical methodology; Resolver B, payer evidence. The same two reader roles are assigned to every forecast registered so far.
What this record will show once it resolves
Beside every result, the count for its class (FDA action by goal date): registered, resolved, unresolved, and expired. One forecast is one instance, not a rate.
- The finding
- As the rule above reads it: occurred on time, did not occur, or left unscored.
- The readers and their sources
- Two reader roles read the source named above: Resolver A, clinical methodology; Resolver B, payer evidence. Who adjudicated it is named here, with the sources they read when the adjudication lists them. Being named as a reader means applying the frozen rule to the public record; it is not support for the estimate, the method, or NextConsensus.
- The number against its baselines
- 45% beside three baselines, each scored by the same rule (squared error), so a reader can see how the record did against each of them.
Reasoning
What the number rests on
The facts it was built from are below, as they stood at the cutoff, with every source archived; each baseline above carries the reasoning that produced it. The written mechanism and the conditions that would make the proposition ill-posed were frozen with the record and are held in the ledger, which the hash on this page covers.
Frozen covariatesThe facts about the evidence and the authority's process that were frozen with the forecast at its cutoff
The state of the record at the cutoff
Recorded as they stood on 2026-10-15.
- review pathway
- Resubmission review; Corcept stated it "expects the resubmission to receive a six-month review" (SRC-003). FDA classification (Class 1/Class 2) is not stated in the archived sources. Center CDER is the drafter's understanding (small-molecule NDA), unverified.
- submission type
- NDA resubmission after Complete Response Letter (SRC-002, SRC-003); the resubmission "includes additional analyses of data included in the original NDA submission" (SRC-003).
- evidence class
- Pivotal Phase 3 GRACE (open-label phase followed by double-blind randomized-withdrawal phase) with confirmatory evidence from Phase 3 GRADIENT, a Phase 3 long-term extension study and a Phase 2 study (SRC-004, SRC-002). CRL stated additional evidence of effectiveness was required (SRC-002).
- pivotal n
- GRACE: 152 patients enrolled in the open-label phase (SRC-002); randomized-withdrawal phase size not stated in the archived sources.
- endpoint type
- GRACE primary endpoint: number of patients who lost blood pressure control on relacorilant vs placebo in the randomized-withdrawal phase (SRC-002).
- approved competitors in class
- Korlym (mifepristone) 300 mg, approved 2012 for hyperglycemia secondary to hypercortisolism in adults with endogenous Cushing’s syndrome with type 2 diabetes or glucose intolerance, and its authorized generic, both sold by Corcept (SRC-002). Other approved Cushing’s therapies are not named in the archived sources.
- months since last guideline revision
- not applicable — no guideline is the subject of this proposition
- panel cycle position
- not applicable — the act is an FDA approval action
- sponsor request status
- Original NDA submitted December 2024; accepted March 2025 with PDUFA date December 30, 2025 (SRC-004); CRL December 30, 2025; FDA asked for additional analyses in April 2026; NDA resubmitted June 17, 2026 (SRC-002, SRC-003).
- odac referral
- none announced in the archived sources
- sponsor state change
- None material reported. Corcept is commercial-stage; relacorilant was approved as Lifyorli for platinum-resistant ovarian cancer in March 2026 (SRC-002, SRC-005). The President of Corcept Endocrinology announced his retirement effective October 1, 2026 (SRC-006).
Sources
Everything the estimate was built from
Each was retrieved on or before the 2026-10-15 cutoff and archived at the digest shown. If a publisher edits a page after the fact, the digest stops matching and the substitution is visible.
-
SRC-001Corcept Form 8-K Exhibit 99.1 (Q2 2026 results press release), filed 2026-07-29. States the relacorilant NDA for Cushing’s syndrome was resubmitted with a PDUFA date of December 17, 2026 and "We expect a decision on our NDA by December 17, 2026." -
SRC-002Corcept Form 10-Q for the quarter ended 2026-06-30, filed 2026-07-29. States the December 30, 2025 CRL and its stated reason, the April 2026 FDA request for additional analyses, resubmission on June 17, 2026, the PDUFA target date of December 17, 2026, the GRACE design/primary endpoint/152 patients, Korlym approval history, and the March 2026 approval of Lifyorli (relacorilant) in ovarian cancer. -
SRC-003Corcept Form 8-K Exhibit 99.1, filed 2026-06-17. Announces the NDA resubmission for relacorilant in Cushing’s syndrome; resubmission includes additional analyses requested by FDA; Corcept expects a six-month review. -
SRC-004Corcept Form 10-Q for the quarter ended 2025-09-30, filed 2025-11-04. States the original NDA for relacorilant in endogenous hypercortisolism was submitted in December 2024 and accepted in March 2025 with a PDUFA date of December 30, 2025, based on GRACE with confirmatory evidence from GRADIENT, a long-term extension study and a Phase 2 study. -
SRC-005openFDA drugsfda query products.active_ingredients.name:"RELACORILANT", retrieved 2026-10-01 (meta last_updated 2026-09-29). Returns only NDA220641 LIFYORLI (COPACKAGED), ORIG-1 approved 2026-03-25; no Cushing’s approval. -
SRC-006Corcept Form 8-K Exhibit 99.1, filed 2026-09-23 (latest Corcept filing before cutoff). Announces retirement of the President of Corcept Endocrinology and appointment of a successor effective October 1; contains no change to the relacorilant review.