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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