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pdufa.bio

HELIOS-3

Updated ยทnext FDA decision on the calendar

HELIOS-3 is a Ocular Therapeutix, Inc program. Its next catalyst is a Readout in Q1 2027. Every date links its source.

OCUL catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Ocular Therapeutix, Inc (OCUL). 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 · Q1 2027OCUL

Questions

When is HELIOS-3's next FDA decision or readout?

The next tracked catalyst for HELIOS-3 is a Readout in Q1 2027.

What happened at HELIOS-3's most recent FDA decision?

No FDA decision for HELIOS-3 is in our archive yet.

Who makes HELIOS-3?

Ocular Therapeutix, Inc (OCUL).

Where does this data come from?

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