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pdufa.bio

HLP003

Updated ยทnext FDA decision on the calendar

HLP003 is a Cybin Inc. program. Its next catalyst is a Readout in Q4 2026. Every date links its source.

HELP catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Cybin Inc. (HELP). 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 2026HELP

Questions

When is HLP003's next FDA decision or readout?

The next tracked catalyst for HLP003 is a Readout in Q4 2026.

What happened at HLP003's most recent FDA decision?

No FDA decision for HLP003 is in our archive yet.

Who makes HLP003?

Cybin Inc. (HELP).

Where does this data come from?

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