Selecta Biosciences announced that the U.S. FDA has placed a clinical hold on its Phase 1/2 clinical trial of SEL-302 due to chemistry, manufacturing and controls-related questions. The stock, which was halted ahead of the news, sank 21% in postmarket trading after resuming.
- This clinical trial had not yet been initiated, and no human patients will be dosed with MMA-101 until all of the FDA’s questions are resolved.
- Selecta intends to work closely with the FDA to address the requests for additional information.
- The trial consists of MMA-101 plus ImmTOR for the treatment of patients with methylmalonic acidemia ...