Corcept Shares Jump 5% as FDA Accepts Drug Application
The U.S. Food and Drug Administration has accepted for review the company's New Drug Application for Relacorilant, a treatment for Cushing's syndrome.
Shares of Corcept Therapeutics (CORT) surged more than 5% after the company announced a significant step forward in its drug development pipeline. The U.S. Food and Drug Administration (FDA) has officially accepted for review the company’s New Drug Application (NDA) for its lead candidate, Relacorilant, intended for the treatment of hypercortisolism, or Cushing's syndrome.
The stock climbed 5.11% on the news, reflecting investor optimism about the drug's path to market. The confirms that the submission is sufficiently complete for a substantive review. The agency has set a Prescription Drug User Fee Act (PDUFA) target action date of December 30, 2025, by which it is expected to make a decision on the drug's approval.
Relacorilant is a selective cortisol modulator that has been granted Orphan Drug Designation for Cushing's syndrome, a rare and serious endocrine disorder caused by prolonged exposure to high levels of the hormone cortisol. Patients often face significant morbidity, and new therapeutic options are critically needed.
Corcept's application is supported by strong clinical data from its pivotal , which demonstrated both efficacy and safety in managing the condition. The acceptance of the NDA is a crucial milestone that moves Relacorilant one step closer to potentially becoming a new standard of care for patients.
This development is part of a broader strategy for the drug candidate. Corcept is also exploring Relacorilant's potential in oncology, having recently announced that the FDA has also accepted an NDA for the drug in combination with nab-paclitaxel for the . That application has a PDUFA date set for July 11, 2026.
Investors will now be closely watching for the FDA's final decision late next year. An approval would represent a major commercial opportunity for Corcept Therapeutics and provide a much-needed new treatment for thousands of patients affected by Cushing's syndrome.