Travere Therapeutics is Friday's IBD Stock Of The Day. The biotech stock is eyeing two potential entries and a second approval for its biggest moneymaker, Filspari.
Filspari treats immunoglobulin A nephropathy, a chronic kidney condition that leads immunoglobulin A, or IgA, to accumulate in the kidneys. The accumulation of this antibody damages the small filters in the kidneys that remove waste products from the blood.
Now, Travere Therapeutics is going for a second approval. Earlier this month, the company asked the Food and Drug Administration to approve Filspari for patients with focal segmental glomerulosclerosis, or FSGS. In this condition, scarring on the kidney filters can lead to kidney failure.
Leerink Partners analyst Joseph Schwartz sees a 75% chance the FDA approves Filspari for patients with FSGS. This would open up a new $1 billion-plus opportunity for Filspari, he said in a recent client note. There are no approved treatments for the roughly 40,000 adults and children in the U.S. with FSGS.
"We think the fact that Filspari could be the first (and only) option approved for FSGS (while it was not the first nor the only option in IgAN) could also fuel the uptake," he said. "Our gross peak sales estimate remains ~$1.1B (US + EU), which requires <20% peak penetration. Considering the lack of any near-term competitive entrants, this could prove to be potentially conservative."
Travere Therapeutics Angles For FSGS Approval
Travere Therapeutics is entering a "busy" 2025, Wedbush analyst Laura Chico said in a report. Filspari's launch in IgA nephropathy is going well. Last year, the kidney drug brought in $132.2 million in sales. During the fourth quarter, Filspari generated $49.6 million in sales. Travere also noted it received 693 new patient start forms, "driven by growth among both new and repeat prescribers."
That followed the full approval of Filspari. Previously, the FDA signed off on the IgA nephropathy drug under an accelerated approval. After Travere Therapeutics finished up confirmatory testing, the FDA converted that to a full approval.
Total fourth-quarter revenue — which includes Thiola, a treatment that prevents the formation of one type of kidney stones — grew more than 84% to $73.5 million. Total 2024 sales were $226.7 million.
It's important to note, Travere isn't profitable. But analysts following the biotech stock expect that to change in the near term. Last year, the company lost $3.05 per share, on an adjusted basis. Losses are projected to shrink this year and disappear next. That puts Travere on a path to profitability in 2026.
Overlap In Prescriber Base
Filspari's potential approval in FSGS treatment likely plays a role in that.
Leerink's Schwartz notes there are fewer patients with FSGS, but the urgency to treat them is higher due to the potential for kidney failure. He expects Travere Therapeutics to double the price of Filspari for patients with FSGS. In IgA nephropathy, Filspari costs $9,900 a month, before insurance kicks in.
"Importantly, the prescriber base is very similar to IgAN (~80% overlap), there is already strong brand awareness, physicians have experience with the drug, and it has strong placement in formularies," he said.
Schwartz has an outperform rating on the biotech stock.
Promisingly, the FDA also removed an extra layer of monitoring for patients who receive Filspari. Doctors will no longer have to watch for embryo-fetal toxicity, a condition that can affect the embryo and fetus during pregnancy. The FDA will also consider removing liver monitoring requires in August.
"Our prior physician checks did not detect significant barriers to prescribing directly from the REMS (Risk Evaluation and Mitigation Strategy)," Wedbush's Chico said. "Clearly, making prescribing easier for physicians would be seen as a positive outcome particularly as more competition emerges in spaces like IgAN."
She has an outperform rating and 30 price target on the biotech stock.
Highly Rated Biotech Stock
Travere stock is consolidating with a buy point at 25.29, according to MarketSurge. But the biotech stock could be actionable earlier if shares retake their March 25 high of 21.35. That would clearly be above the 50-day moving average.
Shares are currently below their 50-day line.
Importantly, Travere Therapeutics has a strong IBD Digital Relative Strength Rating of 98. This means shares outrank 98% of all stocks in terms of 12-month performance.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
