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.