Travere Therapeutics Shares Touch 52-Week Low on FSGS Study Data
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
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
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
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
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 email@example.com
(END) Dow Jones Newswires
May 02, 2023 12:29 ET (16:29 GMT)
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