January 14, 2026
Finance

Travere Therapeutics Faces Investor Concerns Following FDA Review Extension and Sales Forecast

Stock Prices Decline Amid Regulatory Updates and Mixed Analyst Sentiment

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Summary

Shares of Travere Therapeutics, Inc. have experienced a notable decrease following an FDA decision to extend the review period for its supplemental New Drug Application for Filspari. The company also announced a 2025 sales forecast and manufacturing updates, contributing to investor apprehension despite some positive analyst ratings. Technical indicators reveal bearish trends in the stock's short to medium-term outlook.

Key Points

FDA extended the review timeline for Travere's supplemental New Drug Application for Filspari to April 13.
Travere anticipates approximately $127 million in U.S. net product sales for Q4 2025 and has received a $40 million milestone payment from CSL Vifor.
The company plans to restart the Phase 3 HARMONY Study of pegtibatinase in early 2026 after optimizing manufacturing processes.
Technical indicators reflect bearish trends with the stock trading significantly below key moving averages, despite a neutral RSI and bearish MACD signals.

Stocks of Travere Therapeutics, Inc. (NASDAQ:TVTX) experienced a decline on Tuesday as investors responded to recent corporate developments that have triggered selling pressure. The dip in Travere’s share price comes against a backdrop of mixed results in the broader market, with the S&P 500 falling slightly by 0.16% and the Nasdaq registering a marginal increase of 0.02%.

On Tuesday, the U.S. Food and Drug Administration (FDA) announced an extension for its review timeline regarding Travere Therapeutics’ supplemental New Drug Application (sNDA) for Filspari (sparsentan), aimed at treating focal segmental glomerulosclerosis (FSGS). The new Prescription Drug User Fee Act (PDUFA) target date has been moved to April 13.

This extension follows Travere’s recent submission of additional responses to FDA inquiries focused on further clarifying the clinical benefits of Filspari. It is important to note that there were no new requests related to the medication’s safety profile or manufacturing processes.

In parallel with regulatory communications, Travere released preliminary financial results indicating they received further requests from the FDA for more detailed information on Filspari’s clinical benefits, to which the company has already responded. Approval of Filspari would mark a significant milestone as it would become the inaugural medication specifically approved for FSGS, a rare kidney disease characterized by proteinuria that leads to progressive renal decline and potential kidney failure.

Filspari is currently fully approved by the FDA and European Medicines Agency for decelerating kidney function decline in adults suffering from IgA nephropathy, highlighting the drug's existing foothold in kidney disease treatment.

On Monday, Travere projected U.S. net product sales for the fourth quarter of 2025 at approximately $127 million. Furthermore, the company announced receipt of a $40 million milestone payment from collaborator CSL Vifor, attributed to market access achievements linked to their partnership.

Travere also disclosed plans related to its clinical pipeline, specifying that after enhancing its manufacturing process throughout 2025, it anticipates restarting the pivotal Phase 3 HARMONY Study for pegtibatinase, targeting classical homocystinuria, in the first quarter of 2026.

Despite these operational updates, Travere’s stock performance remains under pressure from technical indicators suggesting bearish momentum. As of this week, the stock trades approximately 35.8% below its 20-day simple moving average (SMA), and 21.2% under its 100-day SMA, signaling weakness in both the short and medium term. Over the last twelve months, the shares have increased by 25.82%, yet recent volatility has brought the price closer to its 52-week lows than its highs.

Further analysis of trading metrics reveals a relative strength index (RSI) reading at 43.36, indicating a neutral position without signs of being oversold or overbought. However, the Moving Average Convergence Divergence (MACD) indicator remains below its signal line, reinforcing a prevailing bearish trend in stock momentum.

These mixed technical signals—neutral RSI combined with a bearish MACD—reflect uncertainty in the stock's near-term trajectory, emphasizing the need for cautious interpretation by investors.

Price support and resistance levels have been identified at $22.00 and $26.00, respectively, key thresholds that could influence future trading behavior.

Analyst opinions on Travere Therapeutics show some divergence but generally maintain a positive outlook. The average price target stands at $36.31. Specific recommendations include a 'Buy' rating from HC Wainwright & Co. with a target of $47.00, a 'Neutral' rating by Piper Sandler alongside an increased target of $35.00, and a 'Buy' rating from TD Cowen lifting the target to $40.00.

Additional market intelligence from Benzinga Edge scores Travere Therapeutics highly on momentum, assigning it a score of 94.7 out of 100, suggesting the stock has outperformed the broader market recently. The company’s stock constitutes notable weights in several exchange-traded funds (ETFs), such as 0.46% in the First Trust Small Cap Core AlphaDEX Fund, 0.91% in the First Trust Small Cap Growth AlphaDEX Fund, and 5.04% in the F/m Emerald Life Sciences Innovation ETF.

On Wednesday morning, Travere Therapeutics’ shares were trading down 3.13% at $28.20 in premarket activity, continuing the downward price pressure witnessed earlier.

Risks
  • Uncertainty surrounding FDA approval timeline for Filspari could impact stock performance.
  • Extension of FDA review suggests additional regulatory scrutiny on clinical benefit data.
  • Stock exhibits bearish trading signals, indicating possible downward pressure in stock price.
  • Potential volatility as the company awaits key regulatory and clinical milestones within the next year.
Disclosure
Education only / not financial advice
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TVTX - neutral
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