pdufa.bio

Optune Pax

Updated ยทnext FDA decision on the calendar

Optune Pax 1 FDA decision on record below. Every date links its source.

NVCR catalyst hub

About this program

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

PDUFA · Feb 12, 2026 ✓ ApprovedNVCR

Questions

When is Optune Pax's next FDA decision or readout?

No upcoming catalyst is on our calendar for Optune Pax; 1 FDA decision is on record below.

What happened at Optune Pax's most recent FDA decision?

On Feb 12, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.