Travere Therapeutics (TVTX) sees pre-market drop after regulatory update on Sparsentan development program
What is going on with TVTX?
Shares of Travere Therapeutics (TVTX) saw a pre-market decline today after the biopharmaceutical company announced a regulatory update yesterday, May 25. The regulatory update concerns the sparsentan program for focal segmental glomerulosclerosis (FSGS). During pre-market trading today, shares of Travere Therapeutics fell 12.73%, down to $ 15.49 per share.
What does this mean for Travere Therapeutics Inc?
Focal segmental glomerulosclerosis is a glomerular disease that affects the kidneys. FSGS causes the development of scar tissue on the blood vessels of the glomeruli of the kidneys.
According to the report, the company will not be able to expedite the FDA approval process for sparsentan this year. “We remain very confident in the profile of sparsentan and believe it supports the ability to eventually become a new treatment standard for FSGS, but we are disappointed that we cannot submit this year for expedited approval and deliver it to patients. on our original focused timeline, ”said Eric Dube, CEO of Travere Therapeutics, in a Press release. “Based on our ongoing dialogue with the FDA, we believe the eGFR data has yet to mature to support our new drug request for expedited approval in this indication.
As Travere Therapeutics “no longer expects to submit an application for expedited approval for FSGS in the United States in the second half of 2021,” the company hopes that, with additional study data submitted, it will be able to to submit an application for FDA expedited approval during the first half of 2022.
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Travere Therapeutics Inc is a biopharmaceutical company. The company is focused on the development and commercialization of therapies for people with rare diseases. Its pipeline candidate, sparsentan, is an investigational product candidate in advanced development for focal segmental glomerulosclerosis (FSGS) and IgA nephropathy (IgAN) – rare kidney disorders that often lead to end-stage kidney disease.