Welcome to our dedicated page for Solid Biosciences news (Ticker: SLDB), a resource for investors and traders seeking the latest updates and insights on Solid Biosciences stock.
Solid Biosciences Inc. (Nasdaq: SLDB) is a Cambridge, MA-based biotechnology company focused on developing treatments and cures for Duchenne muscular dystrophy (DMD), a genetic muscle-wasting disease. Solid Biosciences combines commercial acumen with top-tier science to advance promising therapies that address all aspects of DMD. The core of Solid's mission is to improve the daily lives of patients and target the roots of this debilitating condition.
The company's primary focus is on developing gene therapies and other treatments for neuromuscular and cardiac diseases. Their product pipeline includes:
- SGT-003: A next-generation gene therapy candidate for DMD, recently granted FDA clearance for an Investigational New Drug (IND) application. The therapy uses a proprietary capsid (AAV-SLB101) to deliver a microdystrophin transgene to promote muscle function and durability. The planned Phase 1/2 trial aims to evaluate the safety and tolerability of SGT-003 in pediatric patients.
- SGT-501: A treatment for catecholaminergic polymorphic ventricular tachycardia (CPVT), a fatal childhood disease.
- AVB-401: For the treatment of BAG3-mediated dilated cardiomyopathy.
- AVB-202-TT: Aimed at treating Friedreich’s ataxia.
Solid Biosciences has made significant strides in obtaining regulatory milestones. Recently, SGT-003 was granted Orphan Drug Designation (ODD) and Rare Pediatric Disease Designation by the FDA, enhancing its potential marketability and support for clinical development.
The company has also been involved in strategic collaborations and financing activities. Notably, Solid entered a licensing agreement with Armatus Bio for the use of its AAV-SLB101 capsid, securing a non-exclusive worldwide license and upfront and milestone payments. In January 2024, they raised $108.9 million from a private placement to support ongoing pipeline development and business activities.
Financially, Solid Biosciences reported a net loss of $96.0 million for 2023 but expects its cash reserves and recent financing to fund strategic priorities into 2026. As of December 31, 2023, the company had $123.6 million in cash, cash equivalents, and available-for-sale securities.
For more detailed information, visit www.solidbio.com.
Solid Biosciences (Nasdaq: SLDB) has announced participation in two upcoming investor conferences. Chief Technology Officer Joel Schneider and Acting Chief Medical Officer Cathryn Clary will present at the SVB Leerink 10th Annual Global Healthcare Conference on February 24, 2021, at 1:40 p.m. ET, and at the Barclays Global Healthcare Conference on March 11, 2021, at 9:45 a.m. ET. Live webcasts will be available on the company’s investor relations website, with replays also accessible afterwards. Solid Biosciences aims to develop therapies for Duchenne muscular dystrophy through its lead gene therapy candidate, SGT-001.
Solid Biosciences, a life sciences company focused on therapies for Duchenne muscular dystrophy, announced that CEO Ilan Ganot will present at the 39th Annual J.P. Morgan Healthcare Conference on January 14, 2021, at 8:20 am ET. Following the presentation, leadership will be available for Q&A. Institutional investors interested in meetings can contact their J.P. Morgan representative. A live webcast will be accessible on the company's website, with a replay available for 30 days.
Solid Biosciences (Nasdaq: SLDB) announced a $90 million private placement agreement with institutional and accredited investors, set to close around December 15, 2020. The transaction involves issuing 24,324,320 shares at $3.70 each, with investment participation from firms like Suvretta Capital and RA Capital. Proceeds will fund research and development, particularly for SGT-001, and support general corporate purposes. The company plans to file a registration statement with the SEC to register the resale of the shares within 120 days post-closing.
Solid Biosciences (SLDB) reported financial results for Q3 2020 and provided a business update, including the lifting of the FDA clinical hold on the IGNITE DMD trial, with resuming expected in Q1 2021. The company announced a collaboration with Ultragenyx to develop new gene therapies for Duchenne muscular dystrophy, which includes a $40 million investment and potential milestone payments up to $255 million. R&D expenses decreased to $16 million in Q3 2020 from $22.8 million in Q3 2019, while net loss reduced to $21.2 million.
Solid Biosciences Inc. (Nasdaq: SLDB) will announce its third quarter 2020 financial results on November 5, 2020, before the market opens. Management will conduct a conference call at 8:30 a.m. ET to discuss these results and recent business developments. A live webcast will be accessible via the Company's website. Solid Biosciences is dedicated to advancing therapies for Duchenne muscular dystrophy, focusing on correcting the disease-causing mutation with its lead gene therapy candidate, SGT-001.
Solid Biosciences (Nasdaq: SLDB) announced participation in the Chardan 4th Annual Genetic Medicines Conference on October 6, 2020, at 4:45 pm ET. Executives including Jennifer Ziolkowski, Chief Financial Officer, and Joel Schneider, Chief Technology Officer, will engage in a virtual fireside chat. A live webcast will be accessible via the company's Events page and an archived replay will be available for approximately 30 days. Solid Biosciences is dedicated to developing therapies for Duchenne muscular dystrophy, focusing on correcting the underlying mutation with their lead candidate, SGT-001.
Solid Biosciences (NASDAQ: SLDB) announced that its IGNITE DMD Phase I/II clinical trial remains on clinical hold following a serious adverse event. The FDA's hold, initiated in November 2019, requires additional information about manufacturing processes and updated patient safety data. Despite efforts to resolve the hold, including submitting manufacturing improvements, the FDA has requested further details. CEO Ilan Ganot emphasized the commitment to patient safety and ongoing dialogue with the FDA, as the company believes SGT-001 could significantly benefit Duchenne muscular dystrophy patients.
Solid Biosciences Inc. (Nasdaq: SLDB) appointed Ian F. Smith as the new Chairman of the Board, effective June 16, 2020, succeeding co-founder Andrey Zarur, Ph.D. CEO Ilan Ganot praised Zarur's contributions to advancing Duchenne muscular dystrophy therapies. Smith brings extensive biopharmaceutical experience, previously serving as COO and CFO of Vertex Pharmaceuticals. Solid Biosciences focuses on developing gene therapy candidate SGT-001 to address Duchenne at its core.
Solid Biosciences Inc. (Nasdaq: SLDB) has announced a change to its 2020 Annual Meeting of Stockholders, which will now be held virtually on June 16, 2020, at 8:00 a.m. Eastern Time due to COVID-19 restrictions. Shareholders who held shares by April 20, 2020, are entitled to participate and vote. Access to the meeting requires a control number from proxy materials. The company emphasizes that all stockholders should vote in advance, and technical support details are provided in a filed proxy supplement.
Solid Biosciences (Nasdaq: SLDB) announced that its IGNITE DMD Phase I/II clinical trial remains on clinical hold by the FDA. In response to the hold, the company submitted a revised clinical protocol in April 2020, focusing on patient safety and manufacturing process improvements. However, the FDA requested further data, which Solid expects to submit by Q3 2020. SGT-001, their gene therapy candidate for Duchenne muscular dystrophy, aims to deliver a synthetic dystrophin gene and has received designations intended to expedite the drug's development.
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