RTTNews | May 26, 2021 10:38AM EDT

10:38 Wednesday, May 26, 2021 (RTTNews.com) - Travere Therapeutics, Inc. (TVTX) shares are sliding more than 16 percent on Wednesday morning trade after the company said it no longer expects to submit for accelerated approval for its drug candidate Sparsentan as a treatment for focal segmental glomerulosclerosis or FSGS, a type of scarring in kidney, in the U.S. during the second half of 2021.

The company said the FDA has noted in the final pre-NDA meeting minutes, that the available data from the interim assessment of the DUPLEX Study would not be adequate to support accelerated approval.

The biopharmaceutical company has recorded an interim proteinuria endpoint in the ongoing Phase 3 DUPLEX Study of Sparsentan in FSGS. Further, Travere expects to provide additional estimated glomerular filtration data from the DUPLEX Study in the first half of 2022.

Currently, shares are at $14.86, down 16.28 percent from the previous close of $17.75 on a volume of 1,192,710. For the 52-week period, the shares have traded in a range of $14.50-$33.09 on average volume of 534,745.

Read the original article on RTTNews ( https://www.rttnews.com/3197728/stock-alert-travere-slips-16-after-decision-to-hold-accelerated-approval-submission-for-sparsentan.aspx)

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