Cantor Fitzgerald notes that Travere Therapeutics (TVTX) is up 15% following the announcement from Dimerix that the FDA, in written feedback, reconfirmed the percentage reduction of proteinuria at 2 years as an appropriate endpoint for full approval in FSGS for their drug, DMX-200. Given how close the Filspari FSGS PDUFA is, FDA’s consistent messaging on proteinuria reduction as an approvable endpoint for FSGS is a positive for Travere Therapeutics, the firm says. Also, it seems that the FDA could be exercising some flexibility on the specific proteinuria based endpoint that will be sufficient for full approval, Cantor adds. Overall, the firm sees the news as a very positive update for Overweight-rated Travere as FDA’s messaging on proteinuria as an approvable FSGS endpoint is consistent for now, and Dimerix likely has some wood to chop on getting accelerated approval.
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