Street Calls of the Week
Investing.com - Travere Therapeutics (NASDAQ:TVTX) stock rose Wednesday after the company announced the FDA no longer requires an advisory committee meeting for its Sparsentan supplemental New Drug Application (sNDA) in focal segmental glomerulosclerosis (FSGS). The stock, which has surged over 68% in the past year according to InvestingPro data, is currently trading near its 52-week high of $25.29.
The PDUFA date for the regulatory decision remains January 13, 2026, according to the company’s announcement. This development follows the sNDA acceptance with standard review earlier in May, when expectations included an advisory committee meeting.
Stifel maintained its Hold rating and $20.00 price target on Travere following the news. The firm noted that ongoing management commentary indicates interactions with the FDA remain consistent.
The investment firm views this update as "likely a positive" and suggests Sparsentan is "more-likely-than-not to get approved." Stifel had previously questioned whether the agency would want an advisory committee given the precedent-setting nature of full approval based on proteinuria findings versus estimated glomerular filtration rate (eGFR) following PARASOL’s findings.
Stifel also noted that while the stock could trade into the "mid-$20s+" on FSGS approval, longer-term questions remain about whether the approximately 2033 loss of exclusivity will affect merger and acquisition potential or valuation, especially considering expectations for a rapid FSGS launch due to unmet need and pricing tailwind against increasing IgA nephropathy (IgAN) competition. The company, currently valued at $2.46 billion, has shown impressive revenue growth of 88% over the last twelve months, though InvestingPro’s Fair Value analysis suggests the stock may be overvalued at current levels.
In other recent news, Travere Therapeutics has experienced several notable developments. The U.S. Food and Drug Administration (FDA) announced that an advisory committee is no longer required for the review of Travere’s supplemental New Drug Application (sNDA) for FILSPARI, aimed at treating focal segmental glomerulosclerosis (FSGS). The target action date for this application remains January 13, 2026. Additionally, the FDA approved updated monitoring requirements for FILSPARI, reducing the frequency of liver function tests from monthly to every three months and removing the embryo-fetal toxicity monitoring requirement.
Cantor Fitzgerald reiterated an Overweight rating on Travere shares following these announcements. Furthermore, H.C. Wainwright raised its price target for Travere from $30 to $47, maintaining a Buy rating, after the FDA’s approval of the updated Risk Evaluation and Mitigation Strategy (REMS) labeling for FILSPARI. The company also presented new long-term data at the International Congress of Inborn Errors of Metabolism (ICIEM) 2025, showing significant reductions in total homocysteine and methionine in patients treated with their enzyme replacement candidate, pegtibatinase. These developments contribute to the ongoing interest and analysis from investment firms.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.