Travere Therapeutics (TVTX) said late Thursday the US Food and Drug Administration accepted its supplemental New Drug Application for approval of Filspari to treat focal segmental glomerulosclerosis, a kidney disease.
The drug application submission was based on phase 2 and phase 3 trial results involving both adult and pediatric patients, according to the company.
The FDA assigned a Prescription Drug User Fee Act target action date of Jan. 13, 2026, and signaled it is planning an advisory committee meeting regarding the application, the company added.
Shares of Travere Therapeutics were down 23% in after-hours trading.
Disclaimer: Investing carries risk. This is not financial advice. The above content should not be regarded as an offer, recommendation, or solicitation on acquiring or disposing of any financial products, any associated discussions, comments, or posts by author or other users should not be considered as such either. It is solely for general information purpose only, which does not consider your own investment objectives, financial situations or needs. TTM assumes no responsibility or warranty for the accuracy and completeness of the information, investors should do their own research and may seek professional advice before investing.