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News  ›  Benzinga

Corcept Therapeutics Stock Sinks On FDA Setback For Relacorilant

Benzinga Logo Benzinga By Vandana Singh
Corcept Therapeutics Stock Sinks On FDA Setback For Relacorilant

Corcept Therapeutics (NASDAQ: CORT) stock plummeted 41.25% in premarket trading after the FDA issued a Complete Response Letter rejecting the New Drug Application for relacorilant, a treatment for hypertension secondary to hypercortisolism. Despite the pivotal GRACE trial meeting its primary endpoint and confirmatory evidence from the GRADIENT trial, the FDA determined additional evidence of effectiveness was needed before approving the drug. CEO Joseph Belanoff expressed disappointment and stated the company will meet with the FDA to discuss next steps.

Insights
BYDDY   neutral

Used as a competitive benchmarking example


CORT   negative

The company experienced a significant 41.25% stock price decline following FDA rejection of its lead drug candidate relacorilant. Despite meeting primary trial endpoints, the FDA's request for additional evidence represents a major setback for the company's commercial prospects and regulatory timeline.