Why Is Travere Therapeutics Stock (TVTX) Tumbling Today?

Shares in Travere Therapeutics (TVTX) plunged over 33% on Tuesday after the U.S. health watchdog extended its decision date for the biotech firm’s Filspari, a kidney medication formally known as sparsentan.

FDA Demands Additional Information on Filspari

The U.S. Food and Drug Administration (FDA) shifted the decision date from today (January 13) — as TipRanks FDA Calendar shows — to April 13 of this year, Travere Therapeutics said in a statement. The decision is for the use of Filspari to treat focal segmental glomerulosclerosis (FSGS), a group of rare kidney diseases.

The California-based company noted that it recently responded to the FDA’s demand for additional information about the benefits of Filspari for FSGS. Travere had submitted its supplemental new drug application (sNDA) for the treatment plan in March and announced its acceptance in May.

The FDA considered the additional responses as a “major amendment” to the sNDA, Travere noted.

Filspari in FSGS Trial Misses Main Goal

Meanwhile, the negative sentiment greeting the update might also be related to the fact that the mid-stage trial for Filspari in FSGS failed to hit its primary goals. However, Travere noted that the drug helped to reduce proteinuria in patients by 50%, on average, after two years, compared to 32% in the control group.

Proteinuria is the presence of excess protein in the urine. This is often used as a measure of kidney damage, including in conditions such as IgA nephropathy. The biotech firm had said it would use this factor to ask for the FDA’s approval

Already, the FDA has given the go-ahead for the use of Filspari to treat adults with primary IgA nephropathy, a rare kidney disease that causes proteinuria. Travere secured the full approval in 2024.

What Is the Outlook for TVTX Stock?

On Wall Street, Travere Therapeutics’ shares continue to enjoy a Strong Buy consensus rating from analysts. This is based on nine Buys and two Holds issued by 11 analysts over the past three months.

Moreover, the average TVTX price target of $42.60 implies about 52% upside from current trading levels.

See more TVTX analyst ratings here.