Sigilon Therapeutics dives after FDA puts blood disorder trial on hold

Sigilon Therapeutics

09/07/2021 13:21

** Shares of drug developer  SGTX.O  fall 16.6% to $7.70
premarket
    ** Stock set to open at record low
    ** U.S. FDA places early-stage trial of co's experimental
therapy, SIG-001, for treating hemophilia A, on clinical hold (https://refini.tv/2TQld5m)
    ** Hemophilia A is hereditary bleeding disorder caused by
missing or defective factor VIII (FVIII), a clotting protein in
the blood
    ** Clinical hold was initiated following SGTX's submission
of serious adverse event (SAE) and temporary enrollment halt to
FDA and other regulatory agencies
    ** One out of three patients who received drug developed
inhibitors to Factor VIII - SGTX
    ** Co along with regulatory agencies is investigating to
confirm whether there was causal relationship between event and
SIG-001
    ** As of last close, stock has fallen about 81% this year

 (Reporting by Mrinalika Roy in Bengaluru)
 ((mrinalika.roy@thomsonreuters.com))