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.
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