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Strongbridge Biopharma has submitted a New Drug Application (NDA) for RECORLEV® (levoketoconazole) to the FDA for treating endogenous Cushing’s syndrome. The NDA is bolstered by positive results from the Phase 3 SONICS and LOGICS studies, which demonstrated the drug's safety and efficacy. Approximately 40% of U.S. patients are not well-controlled, highlighting a significant need for additional therapies. If approved, RECORLEV could launch in the first quarter of 2022. The drug has also received orphan drug designation from both the FDA and EMA.
Strongbridge Biopharma plc (Nasdaq: SBBP) announced a conference call scheduled for March 3, 2021, at 8:30 a.m. ET to discuss its fourth quarter and full-year 2020 financial results. The call will follow the early morning release of these results. Strongbridge focuses on therapies for rare diseases, with its main products including RECORLEV, currently in Phase 3 trials for Cushing's syndrome, and KEVEYIS, the first FDA-approved treatment for certain types of periodic paralysis. Both products have received orphan drug designations.
Strongbridge Biopharma (Nasdaq: SBBP) has announced the promotion of Richard S. Kollender to president and chief financial officer, taking over from Robert Lutz, effective March 3, 2021. Kollender, who has served as chief operating officer since September 2019, brings over 30 years of biopharmaceutical experience. The company is on track to submit a New Drug Application to the FDA for RECORLEV® for treating endogenous Cushing’s Syndrome within Q1 2021, with a commercial launch anticipated in Q1 2022. This strategic leadership change aims to enhance shareholder value and solidify Strongbridge's position in rare disease therapies.
Strongbridge Biopharma (SBBP) announced the approval of inducement equity awards to ten new employees, comprising a total of 154,800 non-qualified stock options. These options serve as a material incentive for joining the Company, in line with NASDAQ Listing Rule 5635(c)(4). Each option's exercise price matches the closing share price on the grant date. The options will vest over four years, with a one-year cliff. Strongbridge focuses on developing therapies for rare diseases, including their products RECORLEV and KEVEYIS.
Strongbridge Biopharma announces preliminary financial results for Q4 and full-year 2020, projecting KEVEYIS revenue of approximately $8.2 million for Q4 and $30.7 million for the year, marking a 41.5% increase from 2019. The company targets 2021 revenue guidance for KEVEYIS between $34 million to $36 million. Additionally, Strongbridge plans to submit a New Drug Application (NDA) for RECORLEV in Q1 2021 and expects approximately $87.5 million in cash to fund operations into 2023.
Strongbridge Biopharma (Nasdaq: SBBP) announced secondary endpoint results from the Phase 3 SONICS study regarding RECORLEV™ (levoketoconazole) for treating Cushing's syndrome. The study demonstrated significant, durable improvements in signs and symptoms, including acne and hirsutism, with enhancements observed as early as Day 1 of Maintenance. Key findings included reduced free-testosterone levels in women and improved quality of life and depression scores. RECORLEV was well-tolerated, with nausea and headaches as the most common adverse events.
Strongbridge Biopharma (Nasdaq: SBBP) announced participation in fireside chats at the Stifel and Jefferies 2020 Virtual Healthcare Conferences. The Stifel Conference is on November 16, 2020, from 10:40 – 11:10 a.m. ET, while the Jefferies Conference is on November 19, 2020, from 7:55 – 8:25 p.m. GMT. Both presentations will be webcast live, with links available on the Company’s website. Strongbridge Biopharma focuses on therapies for rare diseases, including RECORLEV® and KEVEYIS®, both of which have received orphan drug designation.
Strongbridge Biopharma (SBBP) reported strong Q3 2020 results, with KEVEYIS revenue reaching $8.1 million, up 42% from $5.7 million in Q3 2019. The company is set to submit a New Drug Application for RECORLEV to the FDA in Q1 2021, having reported positive LOGICS study results. The successful $25 million equity raise has bolstered cash reserves to approximately $82 million, extending operational runway into 2023. Third-quarter net loss decreased to $3.2 million, down from $13.8 million in 2019, mainly due to increased KEVEYIS sales and reduced expenses.
Strongbridge Biopharma (Nasdaq: SBBP) has announced a conference call scheduled for October 29 at 4:30 p.m. ET to discuss its third quarter 2020 financial results and provide a business update. This call will follow the anticipated release of financial results that same day. The call can be accessed via phone or through an audio webcast on the company’s website. Strongbridge focuses on therapies for rare diseases, including RECORLEV® for Cushing’s syndrome and KEVEYIS® for primary periodic paralysis, both with orphan drug designations.
Strongbridge Biopharma priced its underwritten public offering of 11,111,111 ordinary shares at $2.25 per share, aiming for gross proceeds of approximately $25 million. The offering, set to close on or around September 21, 2020, will support the development of Recorlev, lifecycle management of Keveyis, and other corporate purposes. The underwriters have a 30-day option to purchase an additional 1,666,666 shares. Jefferies and Stifel are joint book-running managers for the offering.
