Travere Therapeutics said that in order to align resources around its Filspari launch, the company will be undergoing a significant workforce reduction, impacting approximately 20% of non-field-based employees.
Filspari was granted accelerated approval to reduce proteinuria in adults with primary IgAN at risk of rapid disease progression back in February. Now, Travere says it has completed a pre-NDA meeting with the FDA with the goal of submitting an sNDA for full approval of the drug in IgAN in the first quarter of 2024.
However, Travere also said that regulatory engagement for a second indication, focal segmental glomerulosclerosis (FSGS), revealed that phase 3 DUPLEX study results alone are insufficient to support an sNDA submission for Filspari in FSGS. As a result, Travere is conducting additional analyses of FSGS data and intends to re-engage with the FDA in 2024.
To align resources with strategic priorities, the company has decided to implement workforce reductions, focusing on non-field-based roles. This measure is anticipated to result in an estimated annualized savings of approximately $25 million, beginning in 2024.
This strategic reorganization is part of Travere's broader plan to optimize resources and extend its cash runway into 2028. Travere was formerly known as Retrophin, the biopharma company founded by now-convicted drug executive Martin Shkreli, but was rebranded in 2020.