- Solid Biosciences (NASDAQ:SLDB) announces that it has received the FDA's Full Clinical Hold letter related to the suspended IGNITE DMD study of gene therapy SGT-001. It expects to formally respond in the coming weeks.
- In the letter, the agency is requesting additional information prior to the resumption of the clinical trial, including an assessment of the underlying etiology of the serious adverse event (patient was hospitalized), the patient's clinical status and laboratory parameters and any additional measures to address patient safety.
- The agency has also informed the company that it has satisfactorily addressed the manufacturing-related questions that led to the partial clinical hold on the high dose of SGT-001 used in IGNITE DMD. The partial clinical hold is now resolved, allowing the company to use a single lot for dose administration and limiting the number of vials of product required to treat each patient.
- Shares are up a fraction premarket.
- Previously: FDA places Solid Biosciences' DMD study of lead candidate SGT-001 on clinical hold due to adverse event in first patient; shares down 57% premarket (March 15)
- Now read: Solid Biosciences DMD Trial Halted Once Again, Time To Avoid
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