- Akcea Therapeutics, a spinout from California biotech Ionis Therapeutics, is cutting about 10% of its workforce following a rejection of the companies' rare disease drug Waylivra.
- In a Form 8-K filed with the Securities and Exchange Commission, Akcea said the layoffs were part of a "plan to reorganize its workforce to better align with the immediate needs of its business." The biotech also said it notified employees affected by the layoffs on Thursday, and anticipates $2 million to $2.5 million in restructuring charges during the third quarter.
- The layoffs will solely affect Akcea employees in the U.S., and primarily those working in field teams for Waylivra, according to a spokeswoman. Currently, the company employs around 270 staff.
The Food and Drug Administration made an uncommon move late last month. Though the agency typically follows the recommendations of its advisory committees, such as the one that voted 12-8 in favor of approving Waylivra (volanesorsen) for familial chylomicronemia syndrome (FCS), it swung the other on Ionis and Akcea's therapy, issuing a Complete Response Letter.
It's not entirely clear what problems the FDA had with Waylivra's approval application, but Akcea and Ionis plan meet with regulators to iron things out.
Still, the FDA's decision was a tough pill to swallow for Akcea, which had been gearing up for Waylivra's launch by expanding the field team responsible for marketing it. Akcea spent $32.4 million on general and administrative expenses during the second quarter, a more than five-fold increase from the same period a year prior that was mostly due to greater commercialization investment for Waylivra and its other main asset, Tegsedi (inotersen).
Now, those efforts will have to be pulled back.
"We remain very disappointed with the FDA decisions and are working with FDA to confirm a path forward for Waylivra," the company spokesperson wrote in an email to BioPharma Dive. "We express our appreciation of the incredible work that the Akcea team has done for the FCS community in our effort to develop Waylivra."