In This Story
Solid Biosciences Inc. (SLDB+1.85%) has filed its Form 10-K filing for the fiscal year ended December 31, 2024.
The filing includes details on the company's pipeline, focusing on gene therapy candidates for rare neuromuscular and cardiac diseases. The lead candidate, SGT-003, is in a Phase 1/2 clinical trial targeting Duchenne muscular dystrophy. Initial clinical data showed promising microdystrophin expression and muscle integrity improvements.
SGT-212, aimed at treating Friedreich's ataxia, received FDA clearance for an IND in January 2025. A Phase 1b clinical trial is planned for the second half of 2025.
Solid Biosciences is also developing SGT-501 for Catecholaminergic polymorphic ventricular tachycardia, with an IND submission anticipated in the first half of 2025. The FDA and EMA have granted orphan drug designation for SGT-501.
The company relies on third-party manufacturers for its gene therapy candidates and has partnerships for clinical stage manufacturing. Solid Biosciences also holds various intellectual property rights and licenses crucial for its development programs.
The filing outlines risks related to financial position, including significant net losses and the need for additional funding. The company does not expect to generate revenue from product sales in the foreseeable future.
Solid Biosciences faces competition from other companies developing gene therapies for similar indications, and its success depends on obtaining and maintaining regulatory approvals.
The company is subject to various regulatory requirements and compliance with U.S. and international laws, including those related to manufacturing, marketing, and data privacy.
Solid Biosciences employs 100 full-time employees, with efforts focused on research and development, and is headquartered in Charlestown, Massachusetts.
This content was summarized by generative artificial intelligence using public filings retrieved from SEC.gov. The original data was derived from the Solid Biosciences Inc. annual 10-K report dated March 6, 2025. To report an error, please email earnings@qz.com.