FDA Places Partial Hold On Vadadustat Pediatric Studies, Akebia Cuts Over 40% Staff

  • Battered after a surprising FDA rejection for its lead pipeline program last week, Akebia Therapeutics Inc AKBA has layoffs that are now on the way.
  • In a filing with the SEC, Akebia said the FDA issued a partial clinical hold on the drug's pediatric studies. 
  • As a result, Akebia will suspend all vadadustat studies in children.
  • According to the filing, Akebia approved a 42% reduction in its staff. Akebia expects to complete the layoffs rather quickly, noting that the process should be completed by the second quarter.
  • The layoffs represent Akebia's effort to "refocus its strategic priorities around its commercial product, Auryxia, and its development portfolio." 
  • The Company expects to record a one-time restructuring charge of approximately $12 million in Q2 of 2022. 
  • The reduction in force will result in an approximate $60 million - 65 million reduction in net cash required for operating activities through the end of 2023.
  • For Akebia, the layoffs and partial hold also came after the biotech put together $85 million to commercialize vadadustat in a reorganized deal with Vifor Pharma. 
  • Vifor agreed to an additional equity purchase of $20 million. Further, an accelerated $25 million milestone and $40 million in refundable working capital.
  • Price Action: AKBA shares are down 2.49% at $0.56 during the market session on the last check Thursday.
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