Travere Therapeutics shares rise 4.93% premarket after FDA approves updated REMS labeling for FILSPARI.

Travere Therapeutics, Inc. rose 4.93% in premarket trading, with the company announcing that the U.S. FDA has approved updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI (sparsentan), the only Dual Endothelin Angiotensin Receptor Antagonist for the treatment of IgA nephropathy (IgAN). The update reduces the frequency of liver function monitoring to every three months from the onset of treatment with FILSPARI and removes the embryo-fetal toxicity (EFT) monitoring requirement from the REMS. The reduction of FILSPARI liver monitoring REMS from monthly to every three months from the beginning of treatment was supported by safety data from post-marketing surveillance.