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pdufa.bio

Sublingual film

Updated ยทnext FDA decision on the calendar

Sublingual film is a BioXcel Therapeutics program. Its next catalyst is a Readout in Jul 2027. Every date links its source.

BTAI catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: BioXcel Therapeutics (BTAI). 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 · Jul 2027BTAI

Questions

When is Sublingual film's next FDA decision or readout?

The next tracked catalyst for Sublingual film is a Readout in Jul 2027.

What happened at Sublingual film's most recent FDA decision?

No FDA decision for Sublingual film is in our archive yet.

Who makes Sublingual film?

BioXcel Therapeutics (BTAI).

Where does this data come from?

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