Travere Therapeutics will reduce its workforce by 20%, with the job cuts focused on “non-field-based employees,” the company said Tuesday.
The layoffs are part of a shake-up of the San Diego-based company as it focuses on its launch of kidney drug Filspari and develops pegtibatinase as a potential treatment for the metabolic disorder homocystinuria (HCU).
Travere says that the cuts and other cost-reduction measures will save the company $25 million annually and will help extend its cash runway into 2028. At the end of the third quarter, Travere reported $635 million in cash and cash equivalents.
After a meeting with the FDA, Travere said it plans to file for full approval of Filspari (sparsentan) to treat primary immunoglobulin A nephropathy (IgAN) in the first quarter of next year. In February, the FDA granted Filspari an accelerated nod contingent upon the results of a confirmatory trial.
In the 3 PROTECT study, which compared Filspari to the angiotensin II receptor blocker (ARB) irbesartan, Travere’s drug failed to reach statistical significance in kidney function outcomes as measured by the estimated glomerular filtration rate (eGFR).
The margin was narrow, however, as the company said Filspari hit statistical significance for the purposes of its regulatory review in the EU.
Also leaving the door open for full approval was Filspari’s performance in a secondary measure, as the med showed long-term kidney function preservation and achieved a clinically meaningful difference on the eGFR slope versus the comparator.
“Unfortunately, there is uncertainty around a regulatory path forward for FSGS,” Dube said in a release. “While we intend to continue to engage with FDA on a way forward for the more than 40,000 people living with FSGS in the U.S., we must at the same time prioritize our operating expenses.”
Travere's moves come five months after the company sold its bile acid replacement products—including FDA-approved drugs Chenodal and Chobalm—to Mirum Pharmaceuticals. The deal, worth $210 million up front and an additional $235 million in potential milestones, was made to narrow Travere's focus and extend the company’s “cash runway,” Dube said.
Travere is counting heavily on furthering Filspari as a potential blockbuster in IgAN. For decades, blood pressure medicines were the lone treatment in the indication. This month, Swedish company Calliditas expects to receive full approval for its IgAN drug Tarpeyo, which was approved on an accelerated basis in 2021 and has since posted strong phase 3 data. Some patients may be hesitant to use the corticosteroid however because of the side effects.
The layoffs are part of a shake-up of the San Diego-based company as it focuses on its launch of kidney drug Filspari and develops pegtibatinase as a potential treatment for the metabolic disorder homocystinuria (HCU).
Travere says that the cuts and other cost-reduction measures will save the company $25 million annually and will help extend its cash runway into 2028. At the end of the third quarter, Travere reported $635 million in cash and cash equivalents.
After a meeting with the FDA, Travere said it plans to file for full approval of Filspari (sparsentan) to treat primary immunoglobulin A nephropathy (IgAN) in the first quarter of next year. In February, the FDA granted Filspari an accelerated nod contingent upon the results of a confirmatory trial.
In the 3 PROTECT study, which compared Filspari to the angiotensin II receptor blocker (ARB) irbesartan, Travere’s drug failed to reach statistical significance in kidney function outcomes as measured by the estimated glomerular filtration rate (eGFR).
The margin was narrow, however, as the company said Filspari hit statistical significance for the purposes of its regulatory review in the EU.
Also leaving the door open for full approval was Filspari’s performance in a secondary measure, as the med showed long-term kidney function preservation and achieved a clinically meaningful difference on the eGFR slope versus the comparator.
“Unfortunately, there is uncertainty around a regulatory path forward for FSGS,” Dube said in a release. “While we intend to continue to engage with FDA on a way forward for the more than 40,000 people living with FSGS in the U.S., we must at the same time prioritize our operating expenses.”
Travere's moves come five months after the company sold its bile acid replacement products—including FDA-approved drugs Chenodal and Chobalm—to Mirum Pharmaceuticals. The deal, worth $210 million up front and an additional $235 million in potential milestones, was made to narrow Travere's focus and extend the company’s “cash runway,” Dube said.
Travere is counting heavily on furthering Filspari as a potential blockbuster in IgAN. For decades, blood pressure medicines were the lone treatment in the indication. This month, Swedish company Calliditas expects to receive full approval for its IgAN drug Tarpeyo, which was approved on an accelerated basis in 2021 and has since posted strong phase 3 data. Some patients may be hesitant to use the corticosteroid however because of the side effects.