Tag: Travere Therapeutics

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.

Travere Therapeutics, Inc. (NASDAQ: TVTX) experienced a notable surge of 17.65%, concluding the previous session at $7.40. This upswing ensued subsequent to an upgraded recommendation for Travere’s stock by an analyst. On Tuesday, Citigroup elevated its stance on TVTX stock from “Neutral” to “Buy,” concurrently increasing the price target from $7 to $10.

Additionally, Travere (TVTX) reported the successful completion of a pre-NDA meeting with the U.S. Food and Drug Administration (FDA) concerning FILSPARI (sparsentan) in IgA nephropathy (IgAN). Travere intends to submit a supplemental New Drug Application (sNDA) in the first quarter of 2024 to convert the existing U.S. accelerated approval of FILSPARI to full approval.

Moreover, TVTX concluded regulatory discussions on focal segmental glomerulosclerosis (FSGS), with the FDA indicating that the Phase 3 DUPLEX Study results alone are insufficient for an sNDA submission for an FSGS indication for sparsentan. Consequently, the Company plans to conduct additional analyses of FSGS data, with intentions to re-engage with the FDA in 2024.

In Q4 2023, Travere is implementing a strategic reorganization to concentrate near-term resources on the ongoing FILSPARI launch in IgAN and the progression of pegtibatinase in classical homocystinuria (HCU). Following the productive pre-NDA meeting, Travere is set to proceed with its planned sNDA submission for full approval of FILSPARI in IgA nephropathy.

The TVTX team has been meticulously preparing a high-quality application, which is expected to be submitted next quarter. However, there is uncertainty regarding the regulatory path forward for FSGS. Despite the intent to continue engaging with the FDA on the matter, Travere must concurrently prioritize its operational expenses.

Consequently, the company has made the challenging decision to streamline its workforce, aiming to further concentrate resources on the FILSPARI launch and the clinical development of pegtibatinase. This strategic move is anticipated to extend the company’s cash runway into 2028.

Recently, the Company concluded a pre-NDA meeting with the FDA to discuss the confirmatory results from the Phase 3 PROTECT Study and the subsequent steps for submitting an sNDA for full approval. The FDA expressed support for the Company’s plan to submit an sNDA for the conversion from accelerated approval to full approval, and the Company is on track to submit the sNDA in Q1 2024.