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pdufa.bio

OPUS-1

Updated ยทnext FDA decision on the calendar

OPUS-1 is a Vaxcyte, Inc. program. Its next catalyst is a Readout in Q4 2026. Every date links its source.

PCVX catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Vaxcyte, Inc. (PCVX). 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 · Q4 2026PCVX

Questions

When is OPUS-1's next FDA decision or readout?

The next tracked catalyst for OPUS-1 is a Readout in Q4 2026.

What happened at OPUS-1's most recent FDA decision?

No FDA decision for OPUS-1 is in our archive yet.

Who makes OPUS-1?

Vaxcyte, Inc. (PCVX).

Where does this data come from?

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