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pdufa.bio

BIS-001

Updated ยทnext FDA decision on the calendar

BIS-001 is a Supernus Pharmaceuticals, Inc. program. Its next catalyst is a Readout in Dec 2026. Every date links its source.

SUPN catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Supernus Pharmaceuticals, Inc. (SUPN). 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 · Dec 2026SUPN

Questions

When is BIS-001's next FDA decision or readout?

The next tracked catalyst for BIS-001 is a Readout in Dec 2026.

What happened at BIS-001's most recent FDA decision?

No FDA decision for BIS-001 is in our archive yet.

Who makes BIS-001?

Supernus Pharmaceuticals, Inc. (SUPN).

Where does this data come from?

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