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Corcept Therapeutics (CORT) FDA Events

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FDA Events for Corcept Therapeutics (CORT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Corcept Therapeutics (CORT). Over the past two years, Corcept Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as dazucorilant, Korlym, and Relacorilant. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Corcept Therapeutics' Drugs in FDA Review

dazucorilant - FDA Regulatory Timeline and Events

dazucorilant is a drug developed by Corcept Therapeutics for the following indication: In patients with ALS along with cortisol's proinflammatory effects. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Korlym - FDA Regulatory Timeline and Events

Korlym is a drug developed by Corcept Therapeutics for the following indication: In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Relacorilant - FDA Regulatory Timeline and Events

Relacorilant is a drug developed by Corcept Therapeutics for the following indication: Recurrent Platinum-Resistant Ovarian Cancer. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Corcept Therapeutics FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Corcept Therapeutics (CORT) has reported FDA regulatory activity for the following drugs: Relacorilant, Korlym and dazucorilant.

The most recent FDA-related event for Corcept Therapeutics occurred on June 23, 2025, involving Korlym. The update was categorized as "Data Presentation," with the company reporting: "Corcept Therapeutics Incorporated today presented data from the randomized, double-blind, placebo-controlled treatment phase of its CATALYST trial of Korlym® in patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes at the American Diabetes Association's 85th Scientific Sessions."

Current therapies from Corcept Therapeutics in review with the FDA target conditions such as:

  • Recurrent Platinum-Resistant Ovarian Cancer - Relacorilant
  • In patients with hypercortisolism (Cushing's syndrome) and difficult-to-control type 2 diabetes. - Korlym
  • In patients with ALS along with cortisol's proinflammatory effects - dazucorilant

More FDA Event Resources from MarketBeat

  • NDA: New Drug Application
  • ANDA: Abbreviated New Drug Application
  • sNDA: Supplemental New Drug Application
  • BLA: Biologics License Application
  • sBLA: Supplemental Biologics License Application
  • FDA Approved: Approved by the FDA
  • EMA: European Medicines Agency
  • CE Mark: European Union Certification
  • NMPA: China National Medical Products Administration
  • MHLW: Japanese Ministry of Health
  • FDA Meeting: Consultation with FDA
  • Pre-IND: Pre-Investigational New Drug Meeting
  • Breakthrough Therapy: Special FDA designation for promising therapies
  • Fast Track: Accelerated FDA approval pathway
  • Orphan Drug: Designation for rare disease treatments
  • RPD: Rare Pediatric Disease Designation
  • RMAT: Regenerative Medicine Advanced Therapy
  • DSMB Review: Data Safety Monitoring Board Review
  • IDMC Review: Independent Data Monitoring Committee
  • MAA: MHRA Marketing Authorization Application
  • RTF: Refusal to File (Rejected Application)
  • 510(k): FDA Clearance for Medical Devices
  • Rolling Submission: Staggered regulatory review process

This page (NASDAQ:CORT) was last updated on 7/10/2025 by MarketBeat.com Staff
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