- Strongbridge Biopharma plc SBBP has submitted a marketing application seeking approval for Recorlev (levoketoconazole) for the treatment of endogenous Cushing's syndrome, to the FDA.
- Endogenous Cushing's syndrome is a rare endocrine disease caused by chronic elevated cortisol exposure, often resulting in a benign tumor of the pituitary gland.
- The company is preparing for the potential launch of RECORLEV in the first quarter of 2022, subject to approval.
- RECORLEV, the pure 2S,4R enantiomer of the enantiomeric pair comprising ketoconazole, is a next-generation steroidogenesis inhibitor being investigated as a chronic therapy for adults with endogenous Cushing's syndrome.
- Price Action: SBBP shares are up 6.3% at $3.36 in premarket trading on the last check Tuesday.
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