Corcept Announces CHMP Opinion Recommending EU Marketing Authorization for Lifyorli® (Relacorilant)
Corcept Therapeutics announced that the EMA's CHMP has issued a positive opinion recommending EU marketing authorization for relacorilant plus nab-paclitaxel in platinum-resistant ovarian cancer, with a final European Commission decision expected in Q4 2026. The recommendation is based on the Phase 2 and pivotal Phase 3 ROSELLA trials (381 patients, randomized 1:1), in which the combination improved progression-free and overall survival versus nab-paclitaxel alone, with a safety profile consistent with the chemotherapy alone. Relacorilant is already FDA-approved and marketed in the U.S.
Key figures
- Drug Name
- Lifyorli (relacorilant) combined with nab-paclitaxel
- Phase Of Trial
- Phase 3
- Ec decision timing
- Q4 2026
- Rosella enrollment
- 381
- Trial randomization
- 1:1
- Eu patients eligible per year
- at least an equal number to the US
- Us patients eligible per year
- approximately 20,000
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