Guggenheim Reiterates Buy rating and Best Idea on Travere Therapeutics (TVTX)

Guggenheim analyst Vamil Divan reiterated a Buy rating and $49.00 price target on Travere Therapeutics (NASDAQ: TVTX).

The analyst commented: "Travere announced today that the FDA has extended the review timeline for its FSGS sNDA, with a new PDUFA target action date of April 13, 2026. The extension follows the recent submission of responses requested by the FDA to further characterize the clinical benefit of Filspari, with the FDA determining that the additional responses constituted a Major Amendment to the sNDA, extending the action date accordingly. The company reiterated that no additional information relating to safety or manufacturing has been requested. We view this three-month extension as a significant relief relative to the risk of a Complete Response Letter or a prolonged period of ambiguity, which we believe the market was pricing in following last night's disclosure of the FDA information requests and the proximity to today's original PDUFA date. We believe the Major Amendment designation indicates the FDA is actively reviewing new analyses rather than rejecting the application, keeping Travere on a clear path to approval, in our view. We maintain our 85% probability of approval and expect shares to recover meaningfully to >$30 per share levels with a potential path to $40 mark upon approval. We are connecting with Travere management later today but remain confident in ultimate approval given the compelling clinical data and extraordinarily high unmet need in FSGS. We reiterate Buy rating and Best Idea."

For an analyst ratings summary and ratings history on Travere Therapeutics click here. For more ratings news on Travere Therapeutics click here.

Shares of Travere Therapeutics closed at $29.11 yesterday.

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