Cantor Fitzgerald Comments on Travere Therapeutics (TVTX) Amid Shares Gaining 22pct

Cantor Fitzgerald analyst Prakhar Agrawal reiterated an Overweight rating and {REMOVEPT} price target on Travere Therapeutics (NASDAQ: TVTX).

The analyst comments "TVTX stock is up 15%+ on the news that FDA informed the company that following further review of Filspari sNDA for FSGS, an advisory committee (AdCom) is no longer needed. PDUFA date for Filspari in FSGS remains Jan 13, 2026. ● As we noted last week (LINK to note), there was some investor expectation getting priced in that the Filspari AdCom could get canceled. We also connected with the management on this news. Here are the highlights from management conversation: ● FDA communication did not specify the reasons on why an AdCom is no longer needed. ○ Recall that when the FDA initially informed that an AdCom would be needed, even at that time it didn’t give any reasons for scheduling it. ○ Thinking among many was that since this is a precedent setting approval in FSGS, FDA likely needed an AdCom. ● Management reiterated that the information requests from FDA so far have been as expected and consistent with the IgAN sNDA process – see our note from the investor dinner at HC conference last week. ● Mid-cycle review timeline: ○ Since this application is sNDA, the sponsor doesn’t get a lot of formal output/notification from the FDA’s internal mid-cycle meeting but if management had to guess, FDA could have had its internal mid-cycle review meeting around this time or were about to have it. ● Travere is gearing up for commercial launch in FSGS. Implications: ● Management noted two-thirds of FDA AdCom cancelations / no longer needed have resulted in approval. ● The decision to involve an advisory committee is usually at the discretion of the director of the review division. ○ In this case, it should be Aliza Thompson (FDA cardiorenal division head), who has been involved in the PARASOL initiative work in FSGS. ○ Aliza Thompson will also have the ultimate sign-off on this sNDA application."

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 $21.64 yesterday.

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