Investing.com -- Shares of Travere Therapeutics (NASDAQ: TVTX ) tumbled 20% following the news that its kidney disease treatment, Filspari (sparsentan), did not receive priority review status from the U.S. Food and Drug Administration (FDA). The company will now prepare for an advisory panel, a development that analysts believe could delay the drug’s potential market launch.

The setback came as a surprise to investors who had anticipated a faster review process. Stifel analyst Alex Thompson maintained a Hold rating on the stock, noting the delay as a disappointment and pointing out the significance of the upcoming advisory committee (adcom) discussion on the drug’s approval based on proteinuria findings. Cantor Fitzgerald analyst Prakhar Agrawal also commented on the situation, suggesting that despite the near-term challenges and uncertainty with the FDA, the fundamental outlook for Travere Therapeutics remains unchanged with a valuation at $35 per share.

Citi analyst Carly Kenselaar reiterated a Buy rating and a price target of $35.00, expressing confidence in the drug’s approval based on the PARASOL working group’s findings. Kenselaar also highlighted the FDA’s decision to hold an adcom as a standard procedure for novel treatments in areas with no prior approvals. Despite the stock’s decline, the analyst’s stance remains bullish, advising to "be buying the dip."

The FDA’s standard review means that Travere’s Filspari will have a Prescription Drug User Fee Act (PDUFA) date of January 13, 2026, extending the timeline for potential approval. While the delay is not ideal, analysts remain optimistic about the therapy’s prospects, suggesting that the current dip in share price could be an opportunity for investors who are confident in the drug’s eventual success. However, the extended timeline and the necessity of an advisory panel underscore the challenges in bringing new treatments to market, especially in areas where the FDA seeks additional expert input due to the absence of existing approved therapies.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.