Travere Therapeutics Inc

-0.88 (-5.56%)
Products, Other Pre-Announcement

Travere Therapeutics Provides Regulatory Update On Sparsentan Development Program For Focal Segmental Glomerulosclerosis

Published: 05/25/2021 20:30 GMT
Travere Therapeutics Inc (TVTX) - Travere Therapeutics Provides Regulatory Update on Sparsentan Development Program for Focal Segmental Glomerulosclerosis.
Travere - Following Interim Proteinuria Endpoint in Ongoing Phase 3 Duplex Study of Sparsentan in Fsgs, Conducted Pre-nda Interactions With FDA.
Travere Therapeutics Inc - Also Conducted Initial Maa Pre-submission Interactions With Ema.
Travere Therapeutics Inc - No Longer Expects to Submit for Accelerated Approval for Fsgs in U.S. During Second Half of 2021.
Travere - FDA Has Indicated That It May Be Possible to Submit an Application for Accelerated Approval After Additional Data Accrue in Study.
Travere Therapeutics - Believes It May Be Possible to Provide Sufficient Additional Estimated Glomerular Filtration Data From Duplex Study in H1 2022.
Travere - FDA Encouraged Co to Request Follow-up Meeting to Further Explore Option in Greater Detail, and a Type a Meeting is Expected to Occur in Q3.