- Thinly traded Solid Biosciences (SLDB +5.5%) is up, albeit on turnover of only 85K shares, on its announcement that it has received a letter from FDA concerning the full clinical hold on its Phase 1/2 study of gene therapy SGT-001 in patients with Duchenne muscular dystrophy. The agency suspended the study after the first participant experienced a severe reaction requiring hospitalization.
- The agency has requested more information related to causes of the serious adverse event, the patient's clinical status and laboratory parameters and any additional measures to address patient safety. It plans to respond to the letter in the next few weeks.
- The company also reports that the FDA has informed it that it has satisfactorily addressed its manufacturing-related questions that led to the partial clinical hold on the high dose of SGT-001, thereby avoiding any revision to its current manufacturing process.
- DMD-related tickers: (SRPT -2%)(CAPR +1.5%)(CATB -1.2%)(PFE -0.3%)(SMMT -4.5%)(WVE -0.7%)
- 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: Rounds Report: Solid Continued Its Comeback And An Improved FDA Policy To Help Nektar
Original article