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pdufa.bio

SPY001

Updated ยทnext FDA decision on the calendar

SPY001 is a Spyre Therapeutics, Inc. program. Its next catalyst is a Readout in Q3 2026. Every date links its source.

SYRE catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Spyre Therapeutics, Inc. (SYRE). We track 1 catalyst event for this program: 1 upcoming and 0 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 · Q3 2026SYRE

Questions

When is SPY001's next FDA decision or readout?

The next tracked catalyst for SPY001 is a Readout in Q3 2026.

What happened at SPY001's most recent FDA decision?

No FDA decision for SPY001 is in our archive yet.

Who makes SPY001?

Spyre Therapeutics, Inc. (SYRE).

Where does this data come from?

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