Back To Back Trial Failures: Analyst Weighs In On Travere Therapeutics' Prospects, Challenges

William Blair downgraded Travere Therapeutics Inc TVTX to Market Perform.

Thursday, the company's head-to-head Phase 3 PROTECT Study of Filspari (sparsentan) in IgA nephropathy did not meet its confirmatory two-year endpoint of change from baseline in eGFR total slope compared to active comparator irbesartan at two years.

William Blair analysts Tim Lugo, Lachlan Hanbury-Brown, and John Boyle observe that although the confirmatory data for Filspari demonstrate a distinct advantage for patients, reinforcing the case for its ongoing marketing, these findings may offer limited motivation for payers to prefer Filspari over irbesartan. Additionally, there remains uncertainty regarding the market potential for Filspari in IgAN.

Although Filspari holds the distinction of being the inaugural nonimmunosuppressive therapy approved for IgAN, and while the data indicate a tendency favoring Filspari when compared to irbesartan, William Blair shows reservations concerning the clinical significance of the narrow and statistically insignificant improvement over irbesartan. 

While these findings do introduce regulatory considerations for Filspari, the data do not provide adequate grounds for the FDA to contemplate removing the product from the market, the analysts write.

The analysts say the trajectory of Filspari will be the primary catalyst influencing stock performance in the short term, including the early launch in IgAN and forthcoming updates arising from regulatory dialogues regarding a potential course of action in FSGS. 

The successful development of FSGS represents a substantial market opportunity, albeit uncertain, following the adverse Phase 3 DUPLEX study results. 

Concurrently, they recognize the potential of pegtibatinase as a promising asset within the pipeline.

Price Action: TVTX shares are down 41.03 at $7.59 on the last check Thursday.