ARTICLE | Clinical News

FDA places hold on Solid's Phase I/II DMD trial

March 14, 2018 11:20 PM UTC

Solid Biosciences Inc. (NASDAQ:SLDB) lost $14.26 (54%) to $12.05 in after-hours trading Wednesday after it said FDA placed a clinical hold on the Phase I/II IGNITE DMD trial of Duchenne muscular dystrophy candidate SGT-001 after the first patient treated with the gene therapy was hospitalized. The company said it has stopped enrollment and dosing and is awaiting a formal letter from FDA regarding the requirements to resume the trial.

The patient was a non-ambulatory adolescent who received a single IV infusion of 5x10^13 vector genomes per kg (vg/kg) SGT-001. Several days after treatment, the patient was hospitalized due to laboratory findings that included a decrease in platelet count followed by a reduction in red blood cell count and evidence of complement activation...

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