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Thursday, October 1, 2026

Single two-year registrational trial, accelerated approval path backed for Wave's AATD candidate

 

FDA feedback backs single two-year registrational trial and accelerated approval path for Wave's AATD candidate WVE-006

  • FDA supports a single two-year registrational trial design for WVE-006 in AATD RNA-editing program
  • Planned one-year interim analysis may enable WVE-006 to seek accelerated approval based on FDA feedback
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