pdufa.bio

SPY001

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

SPY001 is a Spyre Therapeutics, Inc. program. 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: 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 · Q3 2026SYRE

Specialist biotech funds holding SYRE, 13F for the quarter ended June 30, 2026

FundSharesValue at quarter endFiling
Perceptive Advisors4,319,496$383.5 millionfiled August 14, 2026
RTW Investments4,251,996$377.5 millionfiled August 14, 2026
Cormorant Asset Management225,000$20.0 millionfiled August 14, 2026
OrbiMed Advisors186,145$16.5 millionfiled August 14, 2026

13F reports list long positions in common stock at quarter end, are due 45 days later, and show no short positions or later trades. Notes, warrants and other instruments are not counted as shares.

Questions

When is SPY001's next FDA decision or readout?

No upcoming catalyst is on our calendar for SPY001; no FDA decisions are on record below.

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.