Travere Therapeutics has seen its stock price take a hit following a setback in its FDA review process. On May 16, 2025, the company's stock (NASDAQ: TVTX) was trading at $16.98, marking a significant drop of 19.72% from the previous day's closing price.
The decline follows the FDA's decision not to support the accelerated approval for Travere's drug, sparsentan, based on data from an interim analysis of a Phase 3 trial. The news has led to increased investor concerns over the regulatory hurdles that the company faces, reflecting in the stock's performance. Nasdaq.com has reported on this significant decrease following the FDA's decision.
In response to this development, Travere Therapeutics plans to actively engage with the FDA to address their concerns. The company is exploring potential pathways to gain approval for sparsentan, despite the setback in the accelerated review process. These ongoing efforts and discussions will be crucial for Travere as they navigate these challenging regulatory landscapes.