Benzinga | May 26, 2021 06:35AM EDT

Travere Therapeutics' Sparsentan Program Submission Pushed to 2022; FDA Requires More Data

* Following the pre-NDA meeting, the FDA has asked Travere Therapeutics Inc (NASDAQ: TVTX) to submit additional data for the sparsentan program in focal segmental glomerulosclerosis (FSGS), characterized by scarring (sclerosis) in the kidney.

* The agency indicated that the available data from the interim assessment of the DUPLEX Phase 3 study would not be adequate to support an accelerated approval at this time.

* The company no longer expects to submit for accelerated approval for FSGS in the U.S. during the second half of 2021.

* The company will provide sufficient additional estimated glomerular filtration data from the DUPLEX Study in the first half of 2022.

* A Type A meeting is expected to occur in the third quarter of 2021, a follow-up meeting to further explore this option in greater detail.

* Price Action: TVTX shares closed at $17.75 on Tuesday.