pdufa.bio

neratinib

Page updated ·next FDA decision on the calendar ·Data as of Nov 5, 2026 9:00 PM ET

neratinib is a Puma Biotechnology, Inc. program. Every date links its source.

PBYI catalyst hub

All upcoming FDA decision dates on the 2026 PDUFA calendar

About this program

Sponsor: Puma Biotechnology, Inc. (PBYI). We track 1 catalyst event for this program: 0 upcoming and 1 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 · Oct 2026PBYI

Questions

When is neratinib's next FDA decision or readout?

No upcoming catalyst is on our calendar for neratinib; no FDA decisions are on record below.

What happened at neratinib's most recent FDA decision?

No FDA decision for neratinib is in our archive yet.

Who makes neratinib?

Puma Biotechnology, Inc. (PBYI).

Where does this data come from?

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