TVTX Plummets 25.7% Amid FDA Scrutiny: Is the Biopharma Giant Facing a Regulatory Crossroads?

Summary
• Travere Therapeutics (TVTX) plunges 25.76% intraday to $25.315, erasing $8.78 from its price in under 3 hours.
• FDA requests additional data for Filspari’s FSGS approval, with PDUFA decision looming on January 13.
• Q4 2025 net sales hit $127M, but cash reserves remain robust at $323M.
• Options volatility surges, with 249% implied volatility on January 16 puts.

Travere Therapeutics’ stock has imploded on Tuesday, trading down 25.76% to $25.315 as the FDA’s demand for more data on Filspari’s FSGS efficacy triggers panic. The stock’s intraday range of $23.0–$26.0 underscores extreme volatility, with sector peers like Johnson & Johnson (JNJ) rising 0.64% as a counterpoint. The biopharma sector’s regulatory risk profile is now front and center.

FDA's Data Request Sparks Turbulence in TVTX Trading
The collapse in TVTX shares stems directly from the FDA’s request for additional clinical data to assess Filspari’s benefit in treating focal segmental glomerulosclerosis (FSGS). The agency’s intervention, disclosed in the company’s corporate update, has forced investors to reassess the drug’s approval timeline. With the PDUFA target date of January 13 now clouded by regulatory uncertainty, short-term holders have fled. The stock’s 52-week low of $12.91 looms as a psychological barrier, while the -60.1x dynamic P/E ratio highlights the market’s bearish sentiment toward near-term profitability.

Options Volatility Soars: Strategic Plays for TVTX's Volatile Outlook
• MACD: 0.228 (bearish divergence from 0.749 signal line)
• RSI: 48.9 (neutral, but trending downward)
• Bollinger Bands: Price at $25.315, far below the $32.37 lower band
• 200D MA: $23.12 (price near critical support)

TVTX’s technicals scream short-term bearishness despite a long-term bullish setup. The stock is trading near its 200-day moving average ($23.12), with RSI hovering near 50 but declining. Bollinger Bands show extreme compression, suggesting a breakout is imminent. For traders, the key levels to watch are $23.0 (intraday low) and $25.0 (psychological floor).

Top Options Plays:
1. TVTX20260116P25 (Put):
- Strike: $25.00 | Expiry: Jan 16 | IV: 249.54% | Delta: -0.436 | Theta: -0.1825 | Gamma: 0.0599 | Turnover: $92,268
- IV: High volatility (249.54%) signals strong bearish expectations.
- Delta: -0.436 indicates moderate sensitivity to price drops.
- Theta: -0.1825 shows rapid time decay, ideal for short-term bearish bets.
- Gamma: 0.0599 suggests increasing delta as price falls.
- Turnover: $92,268 confirms liquidity. This put option is a high-leverage play (10.03% leverage ratio) for a 5% downside scenario, projecting a $0.00 payoff if TVTX drops to $24.04.

2. TVTX20260220P25 (Put):
- Strike: $25.00 | Expiry: Feb 20 | IV: 101.42% | Delta: -0.420 | Theta: -0.0271 | Gamma: 0.0468 | Turnover: $2,175
- IV: Mid-range volatility (101.42%) balances risk/reward.
- Delta: -0.420 offers moderate directional exposure.
- Theta: -0.0271 implies slower decay, suitable for mid-term bearishness.
- Gamma: 0.0468 ensures delta responsiveness to price swings.
- Turnover: $2,175 supports reasonable liquidity. This contract offers a 67.55% price change ratio, projecting a $0.00 payoff under a 5% downside scenario.

Aggressive bears should prioritize TVTX20260116P25 for immediate short-term exposure, while TVTX20260220P25 suits those betting on prolonged regulatory uncertainty. If $23.0 breaks, TVTX20260116P25 offers short-side potential.

Backtest Travere Therapeutics Stock Performance
The 3-Day win rate for TVTX after an intraday plunge of at least -26% is 48.63%, with an average return of 0.30% over that period. The 10-Day win rate is higher at 52.00%, with an average return of 1.01%. Over 30 days, the win rate is 52.63%, and the average return is 3.34%. The maximum return during the backtest was 6.45%, which occurred on day 59.

TVTX at a Crossroads: Navigating FDA Uncertainty and Market Volatility
TVTX’s 25.7% plunge underscores the fragility of its FSGS approval hopes, with the FDA’s January 13 PDUFA decision now a high-stakes event. While the stock’s 200-day support at $23.12 and 52-week low at $12.91 offer potential floors, the -60.1x P/E ratio and -25.8% intraday drop signal a bearish near-term outlook. Investors should monitor the FDA’s review timeline and key resistance at $26.0. Meanwhile, sector leader Johnson & Johnson (JNJ) rose 0.64%, highlighting the relative safety of diversified pharma plays. For TVTX, the path forward hinges on regulatory clarity—watch for a breakdown below $23.0 or a rebound above $26.0 to gauge the next move.