Following the news of regulatory success, Travere Therapeutics, Inc. (NASDAQ: TVTX) shares are significantly increasing on the charts today. TVTX stock was trading at $24.06 as of the last check, rising 14.03%. The surge is driven by the news of regulatory process discussion for its medication candidate FILSPARI with the U.S. Food and medication Administration (FDA).
Regulatory Milestone: Type C Meeting Completion
Travere Therapeutics (TVTX) said that it has successfully concluded a Type C meeting with the FDA and intends to submit a supplemental New Drug Application (sNDA) for FILSPARI, aiming for conventional approval for the treatment of focal segmental glomerulosclerosis (FSGS). The sNDA will be supported by currently available clinical data from the Phase 2 DUET and Phase 3 DUPLEX studies. Travere plans to submit the application before the end of 2025’s first quarter.
Resolving an Unfulfilled Medical Need
Over 40,000 people in the US suffer with FSGS, a rare and degenerative kidney disease for which there are presently no authorized treatments. The encouraging results from the DUPLEX and DUET studies reinforce the potential of FILSPARI to address this critical unmet medical need. The findings from these studies align with recent research conducted by the PARASOL workgroup, further emphasizing the role of proteinuria reduction in improving FSGS outcomes.
Scientific Validation and Next Steps
The Type C meeting closely follows a public workshop conducted by the PARASOL workgroup, which highlighted the strong correlation between proteinuria reduction over 24 months and a decreased risk of kidney failure in FSGS patients. These insights strengthen the case for FILSPARI’s approval and provide a robust scientific foundation for Travere’s regulatory submission.
To further elaborate on these developments, Travere Therapeutics hosted a conference call and webcast, offering insights into the regulatory strategy and anticipated milestones for FILSPARI. Investors and stakeholders remain optimistic as TVTX advances toward its next critical regulatory submission.