- Travere Therapeutics Inc (NASDAQ: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.
Celestica Q3 EPS $0.52 Misses $0.62 Estimate
Celestica (TSX:CLS) reported quarterly earnings of $0.52 per share which missed the analyst consensus estimate of $0.62 by 16.13 percent. This is a 48.57 percent increase over earnings of $0.35 per share from the same
