Travere Says FDA Communicated Phase 3 DUPLEX Study Results Alone Are Not Sufficient To Support sNDA Submission For An FSGS Indication For Sparsentan; Co. Plans Conducting Addl. Analyses Of FSGS Data And Plans To Re-engage FDA In 2024
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Travere Therapeutics reported that the FDA indicated the Phase 3 DUPLEX study results for Sparsentan are not sufficient to support a supplemental New Drug Application (sNDA) for FSGS. The company plans to conduct additional analyses of the FSGS data and intends to re-engage with the FDA in 2024.
December 04, 2023 | 9:11 pm
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Travere Therapeutics' Sparsentan Phase 3 study results were deemed insufficient by the FDA for an sNDA in FSGS, leading to a need for further data analysis and a delayed FDA re-engagement until 2024.
The FDA's feedback is a significant regulatory setback for Travere, indicating that the current data from the Phase 3 DUPLEX study is not enough for an sNDA submission. This will likely delay the potential market entry of Sparsentan for the FSGS indication, which could negatively impact investor sentiment and the stock price in the short term. The company's plan to conduct additional analyses and re-engage with the FDA in 2024 suggests a prolonged timeline for potential approval, which may be viewed unfavorably by investors.
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