Corcept Therapeutics' Upcoming FDA Decision: Is A CRL Likely?

Are There Red Flags in the Trial Results? Introduction: Corcept Therapeutics' (CORT) Relacorilant is currently under FDA review with a PDUFA target date of December 30, 2025. This upcoming regulatory milestone is financially pivotal for Corcept to reduce sole reliance on Korlym for revenue generation and shift towards a multi-asset profitability company. If Relacirilant's PDUFA outcome is unfavorable, it would significantly affect Corcept's valuation, since they will have no other pre-registration drug expected to reach approval in the next 3-5 years. Clinical & Regulatory Assessment: Relacorilant, developed by Corcept Therapeutics (NASDAQ:CORT), is a selective glucocorticoid receptor (GR) antagonist designed to control hypercortisolism symptoms in endogenous Cushing's syndrome. Relacorilant's NDA is primarily supported by data from two Phase 3 trials: GRACE and GRADIENT. In the GRACE trial, which enrolled patients with endogenous Cushing's syndrome of all etiologies, relacorilant met its primary endpoint where patients switched to placebo had a significantly higher risk of losing hypertension control. Whereas in the GRADIENT trial, which enrolled patients with adrenal-origin Cushing's syndrome, relacorilant did not met its primary endpoint to reduce mean systolic blood pressure. This suggests that relacorilant might be more effective in endogenous Cushing syndrome patients with non-adrenal atieology, which is the majority of them. But given that the indication for NDA is all endogenous Cushing Syndrome patients (including patients with adrenal adenoma), the failure to meet primary endpoint in GRADIENT trial might increase the risk of getting complete response letter for this application. Despite this, the safety profile of relacorilant is favorable. Financial position outlook: With a market capitalization of 8.9 billion, Corcept Therapeutics holds a strong liquidity position with no long-term debt. Although both R&D and SG&A have increased in recent quarters, there is nothing alarming since it is consistent with company's expanding clinical activities and commercialization preparation prior to Relacorliant PDUFA event. Corcept Therapeutics' share outstanding remained basically unchanged and there is no sign of imminent dilution due to urgent equity financing. This is largely attributable to increase in revenue from further commercialization of their first approved drug Korlym, which allows the company to fund pipeline development. Overall, Corcept is currently in a solid financial position. Benzinga Disclaimer: This article is from an unpaid external contributor. It does not represent Benzinga’s reporting and has not been edited for content or accuracy.