As of 8:54 a.m. ET in New York on Friday, December 26, 2025, U.S. markets are in pre‑market and set to reopen for the regular session at 9:30 a.m. ET.
Travere Therapeutics, Inc. (NASDAQ: TVTX) is entering the post‑holiday session with fresh momentum and a very specific catalyst on investors’ minds: an FDA decision deadline of January 13, 2026 for expanding FILSPARI (sparsentan) into focal segmental glomerulosclerosis (FSGS)—a high‑stakes regulatory event that can move a biotech stock in either direction. [1]
TVTX stock: where it stands heading into today’s open
TVTX’s most recent regular-session close (Christmas Eve, Dec. 24) was $40.28, after a sharp +13.9% move that pushed the stock to an intraday high of $42.13. [2]
Early pre‑market indications this morning have been hovering around the low $40s (with some venue data showing around $40.6). [3]
That kind of gap‑up move right before year‑end is notable on its own—but it’s even more notable because the broader market backdrop is also “thin and twitchy.” Investor’s Business Daily noted that futures were barely moving Friday morning and trading volume is expected to remain light due to the holiday lull (with multiple global exchanges closed for Boxing Day). [4]
Low liquidity doesn’t create fundamentals out of thin air, but it can amplify price moves—especially in catalyst-driven biopharma.
Why TVTX jumped: Wall Street chatter + the FDA clock
The Dec. 24 rally was widely attributed to bullish analyst commentary and rising expectations around the upcoming FDA decision for FILSPARI in FSGS.
- Jefferies analyst Maury Raycroft flagged Travere among biotechs he viewed as attractive takeover candidates looking into 2026, highlighting FILSPARI as a potentially valuable asset. [5]
- Cantor Fitzgerald commentary also helped fan the flames, with market reporting pointing to a more optimistic interpretation of how the FDA may view endpoints tied to proteinuria (protein in urine), a key clinical marker in kidney disease. [6]
The regulatory setup investors are trading
Travere’s own timeline is clear: the FDA accepted its supplemental application for FILSPARI in FSGS and set a PDUFA target action date of Jan. 13, 2026. [7]
There’s also an underappreciated nuance here: when Travere announced FDA acceptance in May 2025, the FDA indicated it was planning to hold an advisory committee meeting. [8] But later, Travere disclosed that in September 2025, after further review, the FDA informed the company an advisory committee was no longer needed—a development many investors interpret as a potential (not guaranteed) de‑risking signal. [9]
The catalyst that matters most: FILSPARI in FSGS (Jan. 13, 2026)
What is FILSPARI?
FILSPARI (sparsentan) is already approved in the U.S. for IgA nephropathy (IgAN). Travere announced full FDA approval for an expanded IgAN indication in 2024, based on data including kidney function preservation versus irbesartan. [10]
Why FSGS expansion is such a big deal
FSGS is a serious kidney disease and a leading cause of kidney failure. Travere has positioned FILSPARI’s FSGS opportunity as potentially transformative, stating that if approved it would be the first and only FDA‑approved treatment for FSGS. [11]
In its FDA acceptance announcement, CEO Eric Dube, Ph.D. framed the moment as a milestone toward delivering “the first approved treatment” for people living with FSGS. [12]
The science backdrop: DUPLEX data and the proteinuria debate
Investors aren’t just trading a calendar date—they’re trading what they believe the FDA will accept as convincing evidence.
In early November 2025, Travere highlighted late‑breaking analyses from the Phase 3 DUPLEX study presented at ASN Kidney Week. The company said significantly more FILSPARI-treated patients achieved proteinuria below 0.7 g/g versus irbesartan, and that hitting this threshold correlated with reduced risk of kidney failure events. [13]
This is exactly why “proteinuria as an approvable endpoint” keeps showing up in analyst notes and market headlines: if the FDA is comfortable anchoring approval decisions to proteinuria reduction (and the relationship between proteinuria and long-term outcomes), that can change how investors handicap the probability of approval.
A related market-moving datapoint this week came indirectly from outside Travere: Cantor Fitzgerald pointed to FDA messaging about proteinuria endpoints (in the context of another company’s FSGS program) and said the consistency of that messaging was a positive read-through for Travere ahead of its Jan. 13 deadline. [14]
Commercial execution: revenue growth is no longer hypothetical
One reason TVTX has been able to attract “real money” attention in 2025 is that it isn’t just a pre-revenue biotech story anymore.
In its Q3 2025 financial update (reported Oct. 30, 2025), Travere reported:
- FILSPARI U.S. net product sales of $90.9 million, up 155% year-over-year
- Total revenue of $164.9 million (including a market access milestone)
- 731 new patient start forms during the quarter [15]
Dube said the company delivered “outstanding commercial performance,” citing growing confidence among physicians and patients. [16]
Travere has also highlighted a quarter-end cash position of $255 million (cash, cash equivalents, and marketable securities as of Sept. 30, 2025), giving it meaningful flexibility heading into 2026. [17]
What Wall Street forecasts look like right now
Analyst targets are not a crystal ball (and they often lag fast moves), but they do show how the Street is framing upside/downside after TVTX’s run.
- TipRanks shows TVTX with Buy and Hold ratings (no Sell ratings shown in the snapshot) and an average price target around $42 over the past three months. [18]
- TradingView’s analyst summary clusters around $41.64 with a cited range roughly $31 to $49. [19]
- MarketBeat’s consensus snapshot shows an average target around $38.71 (with a wider high/low range shown on its page). [20]
The important takeaway for today’s session: after a gap-up toward the low $40s, some consensus targets now sit close to the market price, which can matter tactically. When a stock runs up to (or through) the middle of the Street’s target range, momentum traders may still push it—but longer-horizon funds often become more selective, especially with a binary FDA date ahead.
Positioning and volatility: short interest and “binary-event physics”
TVTX is also a stock where positioning can accelerate moves.
MarketBeat reports short interest of about 10.36 million shares (around 12% of float) with a days-to-cover figure around 4.8 (as of the reporting period shown). [21]
Trefis similarly described a setup where short interest has been notable, while cautioning that holiday volume can distort signals. [22]
This matters because into a binary FDA date, stocks can experience two opposing forces at the same time:
- Run-up behavior: traders buy in anticipation of approval, forcing shorts to manage risk.
- Air pockets: if bullish expectations get “too priced in,” even good news can trigger profit-taking.
Neither is guaranteed—but both are common enough in biotech that investors should plan for wider-than-normal ranges.
If the exchange is closed right now: what investors should know before the next session opens
Because it’s still pre‑market in New York as of this writing, here are the practical things that matter most before the 9:30 a.m. ET open:
1) Treat pre‑market prices as “indications,” not commitments
Pre‑market liquidity is thinner; spreads can be wider; and a few prints can make a stock look stronger (or weaker) than it really is.
2) Watch for headlines tied to FDA “process,” not just the Jan. 13 decision
Between now and Jan. 13, the market can react to:
- FDA commentary in other kidney disease programs that hints at endpoint preferences
- Any late-breaking safety/regulatory clarifications
- Conference commentary or investor event remarks [23]
3) Expect post-holiday tape conditions
With broad markets in a holiday lull and futures barely moving, individual-stock news and positioning can dominate price action more than macro does—especially in biopharma. [24]
4) Know what “success” would likely mean for the narrative
Travere has repeatedly framed potential FSGS approval as enabling a commercial launch in early 2026 and expanding FILSPARI’s impact beyond IgAN. [25]
That’s the bull case in one sentence: commercial growth + a new indication + a first-in-disease label.
5) Know what could break the story
Risks investors typically weigh here include:
- FDA requesting additional data, label restrictions, or post-marketing requirements
- Commercial competition in IgAN (including newer entrants) and whether FILSPARI’s monitoring requirements affect uptake—though Travere did secure a streamlined REMS in 2025 that reduced liver monitoring frequency and removed embryo‑fetal toxicity monitoring requirements. [26]
Beyond FILSPARI: pipeline notes investors may be tracking into 2026
While FILSPARI is the stock’s center of gravity, Travere has a second longer-term program: pegtibatinase for classical homocystinuria (HCU).
Travere has stated it expects to restart enrollment in the Phase 3 HARMONY study in 2026, and the trial is listed on ClinicalTrials.gov. [27]
This isn’t the “today catalyst,” but it matters for investors thinking beyond the Jan. 13 binary event—because the market often re-prices what a company could look like after its next catalyst, not just into it.
The bottom line for TVTX stock today
Travere Therapeutics stock is setting up for a potentially active post-holiday session after a sharp Dec. 24 rally pushed shares into the low $40s. The move has been fueled by a mix of analyst optimism, takeover talk, and—most importantly—investor positioning ahead of the Jan. 13, 2026 FDA decision for FILSPARI in FSGS. [28]
For investors heading into today’s open, the key is to separate what moved the stock (sentiment + positioning + thin trading) from what can ultimately justify the move (FDA outcome and continued commercial execution). And in biotech, it’s wise to assume the market will keep changing its mind loudly—sometimes before breakfast.
References
1. ir.travere.com, 2. finance.yahoo.com, 3. public.com, 4. www.investors.com, 5. www.fool.com, 6. www.fool.com, 7. ir.travere.com, 8. ir.travere.com, 9. ir.travere.com, 10. ir.travere.com, 11. ir.travere.com, 12. ir.travere.com, 13. ir.travere.com, 14. www.tipranks.com, 15. ir.travere.com, 16. ir.travere.com, 17. ir.travere.com, 18. www.tipranks.com, 19. www.tradingview.com, 20. www.marketbeat.com, 21. www.marketbeat.com, 22. www.trefis.com, 23. www.tipranks.com, 24. www.investors.com, 25. ir.travere.com, 26. ir.travere.com, 27. ir.travere.com, 28. www.fool.com
