Corcept: relacorilant NDA PDUFA fijado para el 30 de diciembre de 2025
El comunicado de prensa indica que la NDA para relacorilant en hipercortisolismo tiene una fecha PDUFA del 30 de diciembre de 2025. Esto establece la fecha límite regulatoria para la acción de la FDA sobre la solicitud. La compañía afirma que cree que se cumplirá la fecha límite.
Decisión de la FDA (PDUFA) · 17 dic 2026 · Positivo
Extracto de la fuente
EX-99.1
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cort110425ex991pressrelease.htm
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EXHIBIT 99.1
Corcept Therapeutics Announces Third Quarter Financial Results, Oncology Development Programs and Provides Corporate Update
• Revenue of $207.6 million, compared to $182.5 million in third quarter 2024
• Modified 2025 revenue guidance of $800 – $850 million
• Net income of $19.7 million, compared to $47.2 million in third quarter 2024
• Cash and investments of $524.2 million at September 30, 2025
• Oncology development programs expanded to include new studies in
◦ Earlier-stage ovarian, endometrial, cervical and pancreatic cancers, in combination with chemotherapy
◦ Broad range of solid tumors, in combination with immunotherapy
REDWOOD CITY, Calif., (November 4, 2025) – Corcept Therapeutics Incorporated (NASDAQ: CORT