pdufa.bio

FILSPARI (sparsentan)

Updated ยทnext FDA decision on the calendar

FILSPARI (sparsentan) The FDA approved it on Apr 13, 2026. 4 FDA decisions on record below. Every date links its source.

LGND catalyst hub · TVTX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

We track 4 catalyst events for this program: 0 upcoming and 4 in the record. A PDUFA date is the FDA's target date to complete review of a marketing application; a readout is the sponsor's expected date for clinical trial results. What a PDUFA date is · why we do not compare trial results across drugs.

Catalyst history

PDUFA · Aug 27, 2025 ✓ ApprovedLGNDPDUFA · Aug 27, 2025 ✓ ApprovedTVTXPDUFA · Apr 13, 2026 ✓ ApprovedLGNDPDUFA · Apr 13, 2026 ✓ ApprovedTVTX

Questions

When is FILSPARI (sparsentan)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for FILSPARI (sparsentan); 4 FDA decisions are on record below.

What happened at FILSPARI (sparsentan)'s most recent FDA decision?

On Apr 13, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.

Has FILSPARI (sparsentan) been approved by the FDA?

Yes. The FDA approved an application for FILSPARI (sparsentan) on Apr 13, 2026; the decision page linked above carries the source.

Where does this data come from?

FDA announcements, sponsor press releases and SEC filings; every date on this page links its source.