CSL CSL Limited

By Colin Kellaher

Shares of Travere Therapeutics tumbled nearly 35% and hit a new 52-week low Tuesday after the biopharmaceutical company said a pivotal Phase 3 study of its kidney drug Filspari missed the primary endpoint in patients with the rare kidney disease focal segmental glomerulosclerosis, or FSGS.

The San Diego company said that while the study didn't achieve the primary efficacy endpoint over 108 weeks of treatment, secondary and topline exploratory endpoints trended favorably for Filspari, which earlier this year won accelerated approval from the U.S. Food and Drug Administration to reduce proteinuria in adults with primary IgA nephropathy, a leading cause of chronic kidney disease.

Despite the primary endpoint setback, Travere said it plans to engage with the FDA to explore a potential path forward for Filspari in FSGS.

The company said it also expects to work with CSL Vifor, which holds a license to commercialize Filspari in Europe, to engage with European regulators on an FSGS indication. The European Medicines Agency is currently reviewing Filspari for approval in IgA nephropathy.

Amid a murkier outlook for Filspari's prospects in FSGS, analysts at several Wall Street firms lowered their price targets on Travere shares.

In a research note, Evercore ISI analysts Liisa Bayko and Jingming Chen said they didn't think Travere would have the appetite for another study in FSGS and removed the indication from their model, bringing their price target on the stock to $36 from $26.

Analyst Laura Chico at Wedbush, meanwhile, kept FSGS in her estimates but with a delayed launch timing, trimming her price target on Travere shares to $27 from $29.

Travere in February said the FDA's accelerated approval of Filspari in IgA nephropathy was based on a reduction in proteinuria, or levels of protein in urine, and that continued approval may be contingent on confirmation of a clinical benefit.

The company said it expects topline results later this year from the two-year confirmatory endpoints in a Phase 3 study designed to show whether Filspari slows kidney function decline and to support traditional approval of the drug.

Evercore noted that it doesn't believe the FSGS study has much read-through to Filspari in IgA nephropathy.

Travere shares were recently changing hands at $14.83, down 34%, after touching a 52-week low of $14.76 earlier in the session.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

May 02, 2023 12:29 ET (16:29 GMT)

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