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.
Then, on Monday, Akebia approved a 42% reduction in its staff, it told the SEC. Akebia expects to complete the layoffs rather quickly, noting the process should be completed by the end of the second quarter.
The layoffs represent Akebia’s effort to “refocus its strategic priorities around its commercial product, Auryxia, and its development portfolio.” Akebia did not specify the development programs on which it intends to focus.
Akebia shares, already well below $1 apiece, showed no change ahead of the opening bell on Thursday.
Once a highflier in the biotech world, Akebia has fallen on hard times in recent years, and not just as a result of its CRL. Back in September 2020, the biotech reported a Phase III study for its injectable kidney drug, ESA darbepoetin alfa, missed non-inferiority on the all-important MACE safety measure.
The study came in patients who were not on dialysis, and while another Phase III for those undergoing dialysis did pass the safety test, Akebia’s stock tanked more than 70% in the wake of the miss.
At the time, the whiff was expected to hand Akebia’s rival FibroGen a huge advantage in the CKD arena, but that company also ran into FDA headwinds when the agency issued roxadustat a CRL in the summer of 2021. A negative adcomm vote indicated regulators were concerned with safety here as well.
For Akebia, the layoffs and partial hold also came after the biotech put together $85 million to commercialize vadadustat, thanks to a reorganization of its deal with Vifor. The money came from $20 million in stock purchases, an accelerated $25 million milestone and $40 million in refundable working capital.
Akebia is just one of many biotechs facing tough workforce-related decisions in recent months as the biotech bear market continues. Among the other companies to reduce their staff are bluebird bio, Taysha, Zosano, Ovid, Pacira, Passage, Adaptive and Athenex.