Bullish indicating open at $55-$60, IPO prices at $37
Investing.com -- Shares of Travere Therapeutics (NASDAQ:TVTX) surged 14% Tuesday following the company’s announcement of a successful Type C meeting with the U.S. Food and Drug Administration (FDA). The biopharmaceutical firm revealed plans to submit a supplemental New Drug Application (sNDA) for FILSPARI, targeting the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney disorder.
Travere Therapeutics aims to seek traditional approval based on data from the Phase 3 DUPLEX and Phase 2 DUET studies of FILSPARI, with submission expected by the end of the first quarter of 2025. The company’s CEO, Eric Dube, Ph.D., expressed satisfaction with the FDA meeting’s outcome and the move toward an sNDA submission, emphasizing the urgent need for FSGS treatment options.
The optimism from Travere Therapeutics is bolstered by the recent PARASOL workgroup findings, which highlighted the significance of proteinuria reduction in FSGS as a strong indicator of decreased risk of kidney failure. The positive results from the company’s DUPLEX and DUET studies align with these findings, further supporting the sNDA submission.
Cantor analyst Prakhar Agrawal commented on the development, stating, "This update takes the worst-case scenario off the table for TVTX and reinforces FDA’s willingness to engage in FSGS based on proteinuria endpoints after recent PARASOL findings." Agrawal maintains an Overweight rating on the stock, reflecting confidence in the company’s prospects.
Investors responded positively to the news, driving the stock upward as the company prepares for the next steps in the FDA review process. The potential approval of FILSPARI for FSGS treatment in the U.S. represents a significant milestone for Travere Therapeutics, given the current lack of approved medicines for this condition, which affects over 40,000 individuals in the country.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.