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Strongbridge Biopharma Stock Trading Higher On Detailed Recorlev Data In Cushing's Syndrome


Strongbridge Biopharma plc (NASDAQ: SBBP) has announced detailed results from the previously reported Phase 3 LOGICS study of Recorlev (levoketoconazole) in patients with endogenous Cushing's syndrome.

  • Data were presented at the Annual Meeting of the Endocrine Society.
  • The poster presentation further evaluated the safety and efficacy of Recorlev by comparing the effect of withdrawing Recorlev treatment to placebo versus continuing treatment with Recorlev on the cortisol therapeutic response.
  • As previously reported, the LOGICS study met its primary endpoint with statistical significance. At the end of the randomized-withdrawal (RW) phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol (mUFC) response as compared with those who remained on Recorlev.
  • Urinary free cortisol is a sensitive test for various adrenocortical dysfunction types, particularly hypercortisolism (Cushing syndrome).
  • 45.5% more patients treated with Recorlev maintained mUFC normalization in the active arm than the placebo arm.
  • In the RW phase, the median time on Recorlev was 55.5 days and on placebo was 23.0 days, indicating rapid loss of cortisol control upon Recorlev cessation.
  • Earlier this month, the company submitted a marketing application for Recorlev to treat endogenous Cushing's syndrome to the FDA. 
  • Price Action: SBBP shares are trading 11.6% higher at $3.76 in premarket on the last check Monday.

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Posted-In: Endogenous Cushing's syndrome Phase 3Biotech News Penny Stocks Health Care FDA General

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