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.