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Wave Life Sciences从GSK手中重新获得WVE-006的全部权利

2026-02-02 20:33

  • This follows agreement with GSK, whose respiratory portfolio is focused on large-scale diseases, that Wave is well placed to efficiently advance the WVE-006 program in AATD, a rare condition. 
  • This agreement was made prior to data becoming available from the next cohort of the RestorAATion-2 clinical trial, which remains on track for the first quarter of 2026. 
  • Wave is now accelerating its registrational strategy for WVE-006 and plans to engage with the U.S. Food and Drug Administration (FDA) on a potential accelerated approval pathway, with regulatory feedback expected mid-2026.
  • WVE-006 is a first-in-class RNA editing therapeutic candidate designed to correct the root cause of disease for the 200,000 individuals in the U.S. and Europe living with AATD; no currently approved therapies address both lung and liver manifestations of this disease
  • Wave plans to engage FDA on potential accelerated approval pathway for WVE-006, with regulatory feedback anticipated mid-2026
  • Data from the 400 mg multidose cohort of RestorAATion-2 clinical trial remain on track for first quarter of 2026 and data from the 600 mg single and multidose cohorts are expected in 2026
  • Research collaboration with GSK is ongoing and continues to expand with fourth program now selected to advance
  • Wave continues to expect cash runway into 3Q 2028

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