Corcept Tanks on FDA's CRL to Relacorilant NDA in Hypercortisolism [Yahoo! Finance]
ROCHE HOLDING LTD S/ADR (RHHBY)
NASDAQ:AMEX Investor Relations:
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Source: Yahoo! Finance
for its proprietary, selective cortisol modulator, relacorilant, to treat patients with hypercortisolism (Cushing's syndrome). Shares of Corcept plunged 50.4% on Dec. 31 following the announcement of the news. In December 2024, the company submitted an NDA for relacorilant to the FDA for treating patients with hypercortisolism (Cushing's syndrome). A decision from the regulatory body was expected on Dec. 30, 2025. Relacorilant is a selective cortisol modulator that binds to the glucocorticoid receptor but not to the body's other hormone receptors. The NDA was based on positive data from the GRACE study and confirmatory evidence from the phase III GRADIENT study, as well as long-term extension studies and a phase II study in hypercortisolism. Per the FDA, even though the GRACE study met its primary endpoint and the GRADIENT study supported the findings, the agency could not determine that relacorilant's benefits outweigh its risks without additional evidence of effectiveness
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