Thinly traded micro cap Marker Therapeutics (NASDAQ:MRKR) is down 16% premarket on light volume in apparent reaction to its disclosure that its Phase 2 clinical trial, Marker AML, evaluating its MultiTAA T-cell therapy in post-allogeneic hematopoietic stem cell transplant AML patients has been placed on clinical hold by the FDA until it signs off on the IND.
The agency has requested additional information related to certain quality and technical specifications for two reagents supplied by third-party vendors that the company uses in its manufacturing process.
The company submitted a written response on October 28 and expects a response within 30 days. It plans to launch the study in 2020.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.