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On Friday, Travere Therapeutics (NASDAQ:TVTX), a $1.88 billion market cap biotech company with impressive revenue growth of 76% in the last twelve months, experienced a significant drop in the post-market session, following the news that the U.S. Food and Drug Administration (FDA) set a standard review date of January 13, 2026, for the company’s drug candidate sparsentan. This announcement diverged from expectations of a priority review timeframe for the treatment of Focal Segmental Glomerulosclerosis (FSGS), a rare kidney disorder.
Citi analyst Carly Kenselaar reiterated a Buy rating and a $35.00 price target on Travere stock, advising investors to buy the dip. This aligns with the broader analyst consensus, as revealed by InvestingPro data, showing a highly bullish stance with price targets ranging from $22 to $47. Kenselaar explained that the standard review timeline, while longer than anticipated, does not alter their confidence in the drug’s prospects. The analyst noted that the FDA’s decision to convene an advisory committee (AdCom) is consistent with the agency’s practices for novel treatments for diseases without prior approvals.
The FDA’s intent to hold an AdCom suggests a meticulous approach to the approval process, which may have been influenced by the need to balance their workload. Despite the extended review period, Kenselaar remains optimistic, citing the support from the PARASOL working group for using proteinuria as an approvable endpoint in FSGS treatment and the recent precedent set by Dimerix’s findings.
Furthermore, Citi confirmed with Travere Therapeutics that Aliza Thompson, co-chair of the PARASOL working group, signed the sNDA acceptance letter and is still with the FDA, indicating continuity in the review process. The analyst emphasized that the standard review timeline does not impact their positive stance on the outcomes expected from the regulatory body’s evaluation.
Investors reacted to the FDA’s decision with a sell-off that saw Travere stock decline by approximately 25% after the market closed. Despite this setback, InvestingPro data shows the company maintains strong financial health with a current ratio of 2.05, indicating sufficient liquidity to meet short-term obligations. Additionally, the stock has demonstrated remarkable strength with a 216% return over the past year. Get access to 8 more exclusive InvestingPro Tips and a comprehensive Pro Research Report for Travere Therapeutics, along with 1,400+ other stocks, to make more informed investment decisions. The reassurance from Citi analysts about the potential of sparsentan and the procedural nature of the FDA’s review process may influence market sentiment in the coming days.
In other recent news, Travere Therapeutics reported significant developments in their financial and clinical endeavors. The company exceeded expectations for the first quarter of 2025, with earnings per share (EPS) of -$0.19, outperforming the anticipated -$0.55, and revenue of $81.7 million, surpassing the forecasted $78.05 million. A major contributor to this revenue was FILSPARI, with net sales reaching $55.9 million, marking a 182% increase compared to the previous year. The U.S. Food and Drug Administration (FDA) has accepted Travere’s supplemental New Drug Application (sNDA) for FILSPARI for the treatment of focal segmental glomerulosclerosis (FSGS), a rare kidney condition. An advisory committee meeting is planned, with a target action date set for January 13, 2026. FILSPARI, already approved for IgA nephropathy, could become the first FDA-approved treatment for FSGS if sanctioned. Travere’s CEO, Eric Dube, has expressed optimism about the approval, citing the urgent need for new treatment options for FSGS. The company’s strong financial performance and the potential expansion of FILSPARI into new indications reflect Travere’s ongoing efforts to address rare kidney disorders.
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