Strongbridge Biopharma plc. (SBBP), the stock rallied on Friday, March 19, 2021, and gained 42.43% in the extended trading session. Let’s try to find out the reason behind SBBP surging.
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Positive Results from Phase 3 LOGICS Study of RECORLEV
SBBPparticipated in the Annual Meeting of the Endocrine Society (ENDO), held virtually on March 20 – 23, 2021, and revealed the detailed results from the previously reported Phase 3 LOGICS study of RECORLEV. The results were presented in a poster session at the conference.
Earlier on March 2, 2021, SBBP said that they had submitted an NDA for RECORLEV to treat endogenous Cushing’s syndrome to the FDA.
Chief medical officer of Strongbridge Biopharma. Fredric Cohen, M.D said that he is pleased to share the positive data of the LOGICS study with the scientific community. He further elaborated that together with SONICS, these LOGICS data demonstrate substantial evidence of RECORLEV efficacy and safety and serve as the basis of our New Drug Application which was recently submitted to the FDA.
The poster presentation highlighted the following points
- LOGICS met its primary endpoint with statistical significance. Afterthe RW phase, 54.5% more patients who were withdrawn to placebo had a loss of mean urinary free cortisol (mUFC) response compared with those who remained on RECORLEV (p = 0.0002).
- 45.5% more patients treated with RECORLEV maintaining mUFC normalization in the active arm than the placebo arm (p = 0.0015).
- Median time on RECORLEV was 55.5 days and on placebo was 23.0 days indicating rapid loss of cortisol control upon RECORLEV cessation in the RW phase.
- The most commonly reported adverse events were nausea, hypokalemia, headache, hypertension, and diarrhea, among 80 patients in both phases.
What is RECORLEV: RECORLEV (levoketoconazole) is an investigational cortisol synthesis inhibitor in development to treat patients with endogenous Cushing’s syndrome.
On March 3, 2021, announced its financial results for the fourth quarter, and the full-year ended December 31, 2020, reporting the loss but beating the revenue estimates.
Q4 Financial Highlights
- SBBP reported revenues of $8.23 million for the quarter ended December 2020, compared to revenues of $5.61 million for the same quarter in 2019.
- Strongbridge Biopharma announced a quarterly loss of $0.11 per share compared to the loss of $0.25 per share in Q4 2019 for non-recurring items.
- Selling, general and administrative expenses were $11.6 million for the reported quarter, compared to $12.0 million for the same period in 2019.
- Research and development expenses were $5.3 million for Q4 2020, compared to $8.0 million for the same period in 2019.
Full-year 2020 Highlights
- SBBP reported revenue of $30.7 million for the full year 2020, compared to 21.7 million for 2019.
- SBBP spent$40.9 million for SG&A expenses compared to $49.1 million for the prior year.
- Research and development expenses were $25.8 million for the full year, compared to $30.9 million for the same period in 2019.
- Basic net loss attributable to ordinary shareholders on a GAAP basis was $45.1 million, or $0.78per share for the reported year compared to 49.5 million, or $0.91 per share for the prior year.