Selecta Sinks After Saying FDA Issued Clinical Hold on Trial (1)

Nov. 24, 2021, 9:52 PM

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.

Key Excerpts:

  • 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 ...

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