CASI Pharmaceuticals, Inc. announced that it was was informed via a teleconference with the FDA that CID-103, anti-CD38 antibody, Investigational New Drug (IND) for the treatment of AMR has been placed on clinical hold. FDA plans to provide a formal written response before the statutory deadline. The CID-103 IND application supporting a phase 1-2 study of CID-103 in adults with chronic Immune Thrombocytopenia (ITP) remains open and accrual to the study is expected to commence in first quarter of 2025.
No comments:
Post a Comment
Note: Only a member of this blog may post a comment.