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Strongbridge Biopharma (Nasdaq: SBBP) announced plans for an underwritten public offering of ordinary shares, with an additional 15% option for underwriters. The exact terms and completion of the offering depend on market conditions. Proceeds will be used to further develop and launch RECORLEV in the U.S., manage KEVEYIS, and finance general corporate purposes, including working capital and acquisitions. The offering follows a previously filed shelf registration statement effective since March 27, 2018.
Strongbridge Biopharma announced positive top-line results from its Phase 3 LOGICS study for RECORLEV (levoketoconazole) aimed at treating endogenous Cushing’s syndrome. The study met its primary endpoint with a statistically significant reduction in urinary free cortisol levels (p=0.0002). The company anticipates submitting a New Drug Application (NDA) to the FDA in Q1 2021. Recurring strong performance of KEVEYIS (dichlorphenamide) led to a revenue guidance increase to $28 million-$29 million for 2020. Strongbridge expects to fund operations through Q1 2022, aided by a potential $10 million debt draw.
Strongbridge Biopharma (SBBP) announced positive results from its 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 response in placebo patients compared to the RECORLEV group (95.5% vs 40.9%; p=0.0002). An NDA submission to the FDA is planned for Q1 2021, with a potential launch in Q1 2022. RECORLEV was well tolerated, with no discontinuations due to adverse events among randomized patients. Results support RECORLEV's viability as a treatment option for approximately 8,000 patients in the U.S.
Strongbridge Biopharma (SBBP) reported a 28% increase in Q2 2020 revenue to $7.8 million, up from $6.1 million in Q2 2019. Year-to-date revenue reached $14.4 million, a 38% growth from the previous year. Despite challenges from the COVID-19 pandemic, the company anticipates achieving the higher end of its full-year revenue guidance of $22 million to $26 million. The net loss for Q2 was $17.3 million or ($0.32) per share, influenced by a $7.4 million unrealized loss on warrants. Strongbridge also appointed a new CEO and completed a $30 million debt facility to extend its operational runway.
Strongbridge Biopharma (SBBP) will host a conference call on August 4 at 8:30 a.m. ET to discuss its Q2 2020 financial results and provide a business update. This call will be preceded by the release of the company's financial results on the same day. Participants can access the call via audio webcast on Strongbridge's website. The company is focused on developing therapies for rare diseases, notably RECORLEV (for Cushing’s syndrome) and KEVEYIS (for primary periodic paralysis), both of which have received orphan drug designation.
Dublin, Ireland and Trevose, Pa., July 1, 2020 – Strongbridge Biopharma (Nasdaq: SBBP) announced that the last participant has completed the randomized withdrawal phase of the LOGICS study for RECORLEV® (levoketoconazole), aimed at treating endogenous Cushing’s syndrome, with 43 patients involved. The company expects to report topline data in Q3 2020 and plans to submit a New Drug Application (NDA) to the FDA approximately six months after the results. The ongoing clinical programs, including SONICS and LOGICS, have shown promising outcomes for RECORLEV.
Strongbridge Biopharma (Nasdaq: SBBP) has announced its virtual presentation at the Jefferies 2020 Healthcare Conference on June 4, 2020, at 4:30 p.m. ET. The event will focus on the company's commitment to developing therapies for rare diseases. The presentation will be accessible live and archived on their website's Investor section. Strongbridge's key products include RECORLEV, a cortisol synthesis inhibitor undergoing Phase 3 studies for Cushing’s syndrome, and KEVEYIS, the first FDA-approved treatment for certain periodic paralysis variants.
Strongbridge Biopharma plc (Nasdaq: SBBP) has secured a $30 million debt facility from Avenue Venture Opportunities Fund to enhance its cash position. The initial $10 million was borrowed at closing, with two additional tranches of up to $10 million each depending on clinical trial success and FDA approval for RECORLEV. The facility aims to extend the company's cash runway through Q1 2022, providing financial flexibility without stringent covenants. The company has also issued warrants for the purchase of 267,390 ordinary shares at specified prices, indicating confidence in future growth.
Strongbridge Biopharma (Nasdaq: SBBP) announced that its management team will present at the Solebury Trout Virtual Global Healthcare Conference on May 26, 2020, at 12:00 p.m. EDT. The presentation aims to highlight the company's focus on developing therapies for rare diseases with significant unmet needs. Attendees can access the live webcast and archived presentation on the company's Investor Relations website. Notably, Strongbridge's product lineup includes RECORLEV®, currently in Phase 3 studies for Cushing’s syndrome, and KEVEYIS®, the first FDA-approved treatment for certain forms of periodic paralysis.
Strongbridge Biopharma (SBBP) has announced the completion of enrollment in its Phase 3 LOGICS study for RECORLEV® (levoketoconazole), aimed at treating endogenous Cushing’s syndrome. A total of 44 participants were enrolled in this study, which follows the successful SONICS trial that demonstrated significant efficacy in normalizing urinary free cortisol levels. The company anticipates releasing top-line results in Q3 2020 and plans to submit a New Drug Application (NDA) to the FDA about six months after the data becomes available, marking a crucial milestone in their development pipeline.
