FDA lifts hold on Solid Bio's Duchenne study

• Thinly traded nano cap Solid Biosciences (NASDAQ:SLDB) jumps 61% premarket on robust volume in reaction to the FDA's removal of the clinical hold placed on its Phase 1/2 clinical trial, IGNITE DMD, evaluating gene therapy candidate SGT-001 in patients with Duchenne muscular dystrophy (DMD). The trial was halted pending a review of additional manufacturing information and updated safety and efficacy data.
• The agency suspended the study in November 2019 after a participant experienced a serious adverse event, complement activation, thrombocytopenia, a decrease in red blood cell count, acute kidney injury and cardio-pulmonary insufficiency.
• A hold was also placed on the trial in March 2018 after another participant was hospitalized for decreased platelet count followed by a reduction in red blood cell count and evidence of complement activation.
• https://seekingalpha.com/news/3618777-fda-lifts-hold-on-solid-bios-duchenne-study-shares-rocket-61