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Strongbridge Bio's Recorlev US Application For Cushing's Syndrome Under Review, Potential Approval In Early 2022

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Strongbridge Bio's Recorlev US Application For Cushing's Syndrome Under Review, Potential Approval In Early 2022
  • The FDA has accepted to review Strongbridge Biopharma plc's (NASDAQ: SBBP) marketing application for Recorlev (levoketoconazole) to treat endogenous Cushing's syndrome.
  • Earlier than anticipated, the Company received the official Day 74 letter from the FDA. Within the Day 74 letter, the FDA set a Prescription Drug User Fee Act (PDUFA) target action date of January 1, 2022, reflecting a projected 10-month standard review period.
  • The letter does not mention a plan to hold an advisory committee meeting.
  • Endogenous Cushing's syndrome is a rare endocrine disease caused by chronic elevated cortisol exposure, often resulting from a benign tumor of the pituitary gland.
  • Price Action: SBBP shares are up 0.9% at $2.29 during the premarket session on the last check Thursday.
 

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