On Thursday, H.C. Wainwright adjusted its outlook on Travere Therapeutics (NASDAQ:TVTX), increasing the price target to $19 from the previous $17, while maintaining a Buy rating on the stock.
The revision follows the announcement made on April 24 that the European Commission (EC) has granted conditional marketing authorization for FILSPARI (sparsentan), a treatment for adults with primary IgA nephropathy (IgAN).
The authorization by the EC allows FILSPARI to be marketed in all European Union member states, as well as in Iceland, Liechtenstein, and Norway. This decision was influenced by the Committee for Medicinal Products for Human Use (CHMP)'s favorable opinion delivered in February 2024, and by the encouraging results from the Phase 3 PROTECT trial.
FILSPARI has the distinction of being the first approved non-immunosuppressive treatment for IgAN in Europe, marking a significant milestone in the treatment of this condition. The commercial partner for Travere, CSL (OTC:CSLLY) Vifor, is planning the initial European market launch of FILSPARI in the second half of 2024.
Despite conservative projections of 2024 FILSPARI net sales in the EU4 + UK region amounting to $3.9 million, which would translate to $0.6 million in royalty revenues for Travere, the market is anticipating further information. The company is expected to provide near-term expectations for FILSPARI's European performance during its first quarter 2024 results conference call.
Additionally, there is anticipation for the U.S. Food and Drug Administration's (FDA) formal acceptance of a supplemental New Drug Application (sNDA) for FILSPARI. This would transition the drug from its current accelerated approval in the U.S. to full approval for the treatment of IgAN, and would also establish the Prescription Drug User Fee Act (PDUFA) date for the sNDA.
The price target uplift reflects the analyst's confidence in the drug's commercial prospects following these regulatory advancements.
InvestingPro Insights
In light of the recent developments with Travere Therapeutics (NASDAQ:TVTX) and the optimistic outlook from H.C. Wainwright, InvestingPro has provided some key metrics and tips that might interest investors considering the stock. As of the last twelve months ending in Q4 2023, Travere Therapeutics has a market capitalization of $414.79 million and has experienced a revenue growth of 32.69%, signaling a robust expansion in its financial performance despite a challenging gross profit margin of -76.57%.
One of the notable InvestingPro Tips for TVTX is that the company holds more cash than debt on its balance sheet, which could provide financial flexibility and stability. Additionally, the stock is currently trading near its 52-week low, which might present a buying opportunity for investors who believe in the company's long-term prospects. Moreover, three analysts have revised their earnings upwards for the upcoming period, reflecting a positive sentiment towards the company's future performance.
For those considering diving deeper into Travere Therapeutics' financial health and future outlook, InvestingPro offers a comprehensive list of additional tips. There are 12 more InvestingPro Tips available for TVTX at Investing.com/pro, which could provide valuable insights for a more informed investment decision. To access these insights, use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription.
InvestingPro Data for TVTX also reveals a negative P/E ratio of -3.61, reflecting the company's current lack of profitability. However, the company's recent authorization for FILSPARI in Europe could be a pivotal factor in changing this trajectory. As investors look towards the future with the upcoming U.S. FDA decisions and European market performance, these insights could prove crucial in evaluating the potential of Travere Therapeutics.
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