Travere Therapeutics Surges as Sales of Kidney Drug Spike 182%, Eyes FDA Priority Review for FSGS Treatment

Travere Therapeutics (TVE) has emerged as a standout performer in the biotech sector this quarter, with its shares climbing toward a critical buy point amid a stunning 182% surge in sales of its lead kidney disease drug. The company’s momentum is fueled by robust demand for its treatment for focal segmental glomerulosclerosis (FSGS), a rare kidney disorder, and anticipation of a potential FDA priority review for an expanded indication. For investors, the combination of strong execution, a compelling pipeline, and regulatory tailwinds could position Travere as a key player in the nephrology market.

The Sales Surge: A Catalyst for Growth

At the heart of Travere’s recent success is its drug odiparcil, a treatment for FSGS, a condition that can lead to end-stage kidney disease. The company reported third-quarter revenue of $45.2 million, with odiparcil sales alone jumping 182% year-over-year. This growth outpaces even the most optimistic analyst estimates, driven by both new patient enrollments and its entry into international markets, including the EU, where it received approval earlier this year.

The stock’s trajectory mirrors its financial turnaround. After bottoming at $4.30 in early 2023, TVE has rallied nearly 200% to its current price of $13.20, approaching a key resistance level of $14. Analysts attribute this rise to the odiparcil sales boom and the company’s strategic focus on niche therapies with high unmet need.

FDA Priority Review: A Game-Changer for FSGS

Looking ahead, Travere’s most significant catalyst is the potential FDA priority review for odiparcil in FSGS patients. In August, the company announced it had submitted a New Drug Application (NDA) for the treatment, seeking accelerated approval under the FDA’s Breakthrough Therapy designation. If granted priority review, the decision timeline could be cut to six months instead of the standard 10, with a PDUFA date as early as mid-2024.

FSGS affects approximately 20,000 to 30,000 patients in the U.S., and odiparcil is the first therapy shown to slow kidney function decline in clinical trials. With no FDA-approved treatments currently available for this indication, Travere could capture a dominant market share, potentially generating peak annual sales of $400 million, according to Cowen & Co. analyst estimates.

Risks and Considerations

Despite the optimism, risks remain. The FDA could request additional data or delay the review process, which would pressure the stock. Additionally, Travere’s reliance on a single drug—odiparcil accounts for nearly 80% of revenue—exposes it to potential setbacks. The company is also in early-stage trials for a treatment for autosomal dominant polycystic kidney disease (ADPKD), but that program is years away from commercialization.

Conclusion: A Buy at Current Levels?

Travere’s recent performance and pipeline milestones suggest it’s on track to deliver outsized returns. The 182% sales growth in odiparcil underscores strong clinical demand, while the potential FDA nod for FSGS could unlock a multibillion-dollar addressable market. With a market cap of $800 million and a price-to-sales ratio of 5.6x (well below peers like Alnylam Pharmaceuticals or BioMarin Pharmaceutical), TVE appears undervalued relative to its growth trajectory.

Analysts at Jefferies recently raised their price target to $18, citing the FSGS NDA’s potential, while the average Wall Street rating remains a “Buy.” The stock’s current price-to-research-and-development expense ratio of 2.1x also signals a favorable valuation for a company with a late-stage pipeline.

Investors should watch for two key catalysts: the FDA’s acceptance of Travere’s NDA for priority review by early 2024 and further odiparcil sales data in Q1 2024. With its stock near a pivotal technical level and a clear path to regulatory approval, Travere’s recent rally may just be the beginning of a sustained upward move.