Why Travere Therapeutics (TVTX) Shares Are Plunging Today - Travere Therapeutics (NASDAQ:TVTX)

Travere Therapeutics Inc TVTX expects the November 17 PDUFA date for accelerated approval of lead drug sparsentan in IgA nephropathy to be extended by three months. The exact date is to be confirmed.
The FDA requested that the company update its proposed Risk Evaluation Mitigation Strategy to include liver monitoring.
HC Wainwright reduced the price target to $36 from $42, with a Buy rating.
The analyst notes that as with all other endothelin receptor antagonists (ERAs), sparsentan is associated with occasional transient elevations of liver enzymes during treatment.
However, management noted that patients on sparsentan have experienced "only a few cases."
So, why would the FDA request additional monitoring in the absence of direct evidence of theoretical liver toxicity on sparsentan therapy?
Management posited three key factors likely driving the agency's rationale:
- Consistency: liver monitoring is on the label for some other drugs in the class.
- Caution: FDA is considering accelerated approval.
- Caution: With all prior ERAs indicated for pulmonary arterial hypertension (PAH), prescribing this class of drugs is expected to be all-new to nephrologists.
Price Action: TVTX shares are down 8.93% at $21.12 on the last check Friday.

Analyst Cuts Price On Travere Therapeutics Citing Expected Delayed PDUFA