Travere Therapeutics Inc. (NASDAQ:TVTX) shares are up on Tuesday following the announcement of full FDA approval for FILSPARI (sparsentan) for a rare kidney condition in adult and pediatric patients aged 8 years and above.

FDA Approval Expands Addressable Patient Population

Travere Therapeutics is a biopharmaceutical company focused on developing therapies for rare kidney, liver, and metabolic diseases.

FSGS is a kidney disease characterized by scarring (sclerosis) in scattered, specific parts (segmental) of some (focal) glomeruli, leading to nephrotic syndrome.

It causes protein leakage, swelling (edema), high blood pressure, and potential kidney failure.

The approval expands the potential patient population to over 100,000 individuals in the U.S., including more than 30,000 FSGS patients who do not have nephrotic syndrome.

The approval of FILSPARI marks a historic milestone as it becomes the first and only FDA-approved treatment for FSGS without nephrotic syndrome.

Strong Clinical Outcomes In Non-Nephrotic Patients

In the Phase 3 DUPLEX Study, the largest head-to-head interventional study in FSGS to date, patients treated with FILSPARI in the overall study population experienced a statistically significant 46% reduction in proteinuria from baseline to Week 108 compared to 30% for those treated with maximum labeled dose irbesartan.

In patients without nephrotic syndrome, FILSPARI demonstrated even greater improvements compared to the maximum labeled dose of irbesartan across proteinuria and eGFR.

Those without nephrotic syndrome who were treated with FILSPARI experienced a 48% reduction in proteinuria from baseline to Week 108 compared to 27% for those treated with irbesartan, which was statistically significant.

FILSPARI-treated patients without nephrotic syndrome also demonstrated a benefit in eGFR.

Travere Technical Setup Signals Continued Bullish Momentum

Travere Therapeutics is currently trading above its 20-day simple moving average (SMA) by 52.7%, indicating strong short-term momentum. It is also 39.4% above its 100-day SMA, suggesting that the intermediate trend remains bullish as well.

The stock’s 12-month performance shows a remarkable gain of 107.01%, reflecting strong investor confidence and interest over the past year. Currently, the stock is positioned near its 52-week high of $44.30, which suggests that it is experiencing strong upward momentum.

  • Key Resistance: $44.50 — This level may act as a barrier for further upward movement.
  • Key Support: $42.00 — This level could provide a safety net for buyers if the stock retraces.

TVTX Price Action: Travere Therapeutics shares were up 37.12% at $42.09 at the time of publication on Tuesday. The stock is trading near its 52-week high of $42.13, according to Benzinga Pro data.

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