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Strongbridge Biopharma plc (Nasdaq: SBBP) announced that post hoc analyses from a year-long study on KEVEYIS (dichlorphenamide) confirm its long-term safety and effectiveness for treating Primary Periodic Paralysis (PPP). Results published in Muscle & Nerve highlight maintained efficacy over 61 weeks, with reduced attack rates among users. Adverse events, primarily paresthesia and cognitive impairment, were lower in frequency during the study's final 52 weeks. These findings support KEVEYIS as a key treatment option for this rare neuromuscular disorder.
Strongbridge Biopharma plc (Nasdaq: SBBP) announced the issuance of U.S. Patent No. 11,020,393 for methods of treating Cushing’s syndrome with RECORLEV® (levoketoconazole) alongside metformin for Type 2 diabetes. This patent extends protection until March 2, 2040, marking the third U.S. patent for RECORLEV. The drug is under FDA review for treating endogenous Cushing’s syndrome. Strongbridge’s RECORLEV has shown effectiveness in reducing serum cortisol in Phase 3 studies, contributing to their rare endocrine portfolio along with other investigational therapies.
Xeris Pharmaceuticals (XERS) has announced an agreement to acquire Strongbridge Biopharma (SBBP) for approximately $267 million in stock and contingent value rights (CVRs). Strongbridge shareholders will receive a fixed exchange ratio of 0.7840 shares of the new entity, Xeris Biopharma Holdings, and potential CVRs based on sales milestones of KEVEYIS® and RECORLEV®. This merger aims to create a diversified biopharmaceutical company focused on rare diseases, enhancing revenue growth with commercial assets like Gvoke® and RECORLEV®. The transaction is expected to close in Q4 2021.
Strongbridge Biopharma, (Nasdaq: SBBP), announced that the FDA has accepted its New Drug Application for RECORLEV® (levoketoconazole) aimed at treating endogenous Cushing’s syndrome, with a PDUFA target date of January 1, 2022. The company plans to launch RECORLEV in the first quarter of 2022, pending approval. The Phase 3 SONICS and LOGICS studies showed significant efficacy and safety of RECORLEV. The acceptance suggests robust clinical evidence, as the company advances its commercial readiness to provide a new therapy for this serious condition.
Strongbridge Biopharma plc (SBBP) reported a first quarter 2021 revenue of $8.4 million, reflecting a 25% increase from $6.7 million in Q1 2020. The company reiterates its full-year 2021 revenue guidance for KEVEYIS® (dichlorphenamide) between $34 million and $36 million. Strongbridge is awaiting FDA's Day 74 letter for its New Drug Application (NDA) submission for RECORLEV® (levoketoconazole) and received a Notice of Allowance for a patent related to its use in Cushing's syndrome treatment. The company has around $73.9 million in cash as of March 31, 2021.
Strongbridge Biopharma plc (Nasdaq: SBBP) will host a conference call on May 12, 2021, at 8:30 a.m. ET to discuss its first quarter 2021 financial results and corporate highlights. The call will follow the release of financial results earlier that day. Interested parties can access the call by dialing (844) 285-7153 (domestic) or (478) 219-0180 (international) using conference ID 9478726. A replay will be available for one week after the call. Strongbridge focuses on therapies for rare diseases, including RECORLEV® and KEVEYIS®, with orphan drug designations.
Strongbridge Biopharma announced significant findings from the Phase 3 SONICS study of RECORLEV (levoketoconazole) for treating endogenous Cushing's syndrome, particularly in patients with comorbid diabetes mellitus. The study revealed meaningful improvements in cortisol control, hemoglobin A1c, and cardiovascular risk markers. Notably, adverse events occurred without prompting drug withdrawal. The results were published in Frontiers in Endocrinology and underscore RECORLEV's potential as a treatment option for Cushing's syndrome patients.
Strongbridge Biopharma (SBBP) announced the presentation of detailed results from the Phase 3 LOGICS study of RECORLEV® (levoketoconazole) for treating endogenous Cushing’s syndrome. The study met its primary endpoint, showing a 54.5% greater loss of cortisol control in patients switched to placebo compared to those continuing RECORLEV (p=0.0002). Additionally, significant secondary endpoints included a 45.5% normalization rate of mean urinary free cortisol (p=0.0015). The findings support a New Drug Application (NDA) submitted to the FDA. If approved, RECORLEV may provide a new treatment option for patients.
Strongbridge Biopharma plc (Nasdaq: SBBP) announced its participation at Oppenheimer’s 31st Annual Healthcare Conference on March 17, 2021, at 10:00 a.m. ET. The presentation will be held virtually and will be available via live webcast and archival on the company’s website. Strongbridge focuses on therapies for rare diseases, with products such as RECORLEV for endogenous Cushing’s syndrome and KEVEYIS for periodic paralysis. Both have received orphan drug designations from the FDA and the EMA.
Strongbridge Biopharma (SBBP) announced the submission of a New Drug Application (NDA) for RECORLEV® aimed at treating endogenous Cushing’s syndrome. The company reported full-year 2020 revenue of $30.7 million for KEVEYIS®, reflecting a 41.5% increase over 2019. They forecast KEVEYIS revenue for 2021 between $34 million and $36 million. As of December 31, 2020, Strongbridge held $87.5 million in cash, sufficient to fund operations into early 2023. Despite a net loss of $45.1 million for the year, non-GAAP losses improved due to increased revenue and reduced expenses.
