In a one-two gut punch after kidney drug CRL, Akebia slapped with partial hold and will lay off 42% of staff

Snakebit after a surprising CRL for its lead pipeline program last week, Akebia Therapeutics is facing another roadblock at the FDA — and layoffs are now on the way.

In a filing with the SEC on Thursday morning, Akebia said that on April 1, three days after receiving its CRL for vadadustat to treat anemia due to chronic kidney disease in adults, the FDA issued a partial clinical hold on the drug’s pediatric studies. As a result, Akebia will suspend all vadadustat studies in children