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KYV-101 KYSA-1

Updated ยทnext FDA decision on the calendar

KYV-101 KYSA-1 Every date links its source.

KYTX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Review status: KYSA-1 (NCT05938725) was TERMINATED; ClinicalTrials.gov records the reason as 'Study discontinued due to sponsor decision' (status verified 2026). The related KYSA-3 lupus nephritis trial (NCT06342960) is also terminated for the same stated reason. No topline readout will occur from this trial; primary completion is recorded as ACTUAL 2026-05-29. We track 1 catalyst event for this program: 0 upcoming and 1 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

Readout · Aug 2026KYTX

Questions

When is KYV-101 KYSA-1's next FDA decision or readout?

No upcoming catalyst is on our calendar for KYV-101 KYSA-1; no FDA decisions are on record below.

What happened at KYV-101 KYSA-1's most recent FDA decision?

No FDA decision for KYV-101 KYSA-1 is in our archive yet.

Where does this data come from?

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