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

Following the pre-NDA meeting, the FDA has asked Travere Therapeutics Inc 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.