Shares of biotechnology company Sigilon Therapeutics Inc. touched a 52-week low Friday after the company said the U.S. Food and Drug Administration placed its Phase 1/2 study of SIG-001 in patients with severe or moderately severe hemophilia A on clinical hold.
Sigilon said the hold was initiated after it submitted a serious adverse event and temporary enrollment halt to the FDA and other agencies.
At 1:05 p.m. ET, the company's shares were trading 24% lower at $7.06. Volume at the time topped 1.4 million shares. The stock's 65-day average volume is 159,069.
Earlier in the session, the shares touched a 52-week low of $6.28.
The company said one of three patients dosed with SIG-001 developed inhibitors to Factor VIII. The patient is responding well to medical treatment and his condition continues to improve, it said.
"Patient safety is our top priority, and we are encouraged that the patient is recovering," said Rogerio Vivaldi, the company's president and chief executive. "In collaboration with the regulatory agencies and our advisors, we are conducting a thorough investigation of this event to confirm whether there was a causal relationship between the development of inhibitors and SIG-001. We are committed to working with the FDA to resolve the clinical hold."
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.