Serious Adverse Event Triggers FDA Clinical Hold On Sigilon Therapeutics' Hemophilia A Trial, Shares Drop

  • The FDA has instituted a clinical hold on Sigilon Therapeutics Inc's SGTX Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A. 
  • The clinical hold was initiated following the Company's submission of a serious adverse event (SAE) and temporary enrollment halt to the FDA and other regulatory agencies.
  • To date, three patients have been dosed with SIG-001. 
  • The third patient, who received the highest dose of the study drug, developed inhibitors to Factor VIII (FVIII), a known complication of FVIII therapy. However, the patient is responding well to medical treatment. 
  • The FDA has requested additional information or data on factors potentially contributing to the development of inhibitors in this patient. 
  • All three patients enrolled in this study will continue to be followed per study protocol while the Company investigates the SAE. 
  • The status of the SAE investigation will continue to be reviewed by the Safety Review Committee for SIG-001, and Sigilon will provide additional data when available. 
  • Price Action: SGTX shares are down 24.2% at $7 during the premarket session on the last check Friday.
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Posted In: BiotechNewsHealth CareFDAGeneralBriefsHemophilia A
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