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

by Vandana Singh, Benzinga Editor

May 13, 2021 9:28 AM | 1 min read

The FDA has accepted to review Strongbridge Biopharma plc's 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.

Posted In: Biotech News Penny Stocks Health Care FDA General Briefs Endogenous Cushing's syndrome

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