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SPINRAZA (Nusinersen)

Updated ยทnext FDA decision on the calendar

SPINRAZA (Nusinersen) 2 FDA decisions on record below. Every date links its source.

BIIB catalyst hub · IONS catalyst hub

About this program

We track 2 catalyst events for this program: 0 upcoming and 2 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 · Mar 30, 2026 ✓ ApprovedBIIBPDUFA · Mar 30, 2026 ✓ ApprovedIONS

Questions

When is SPINRAZA (Nusinersen)'s next FDA decision or readout?

No upcoming catalyst is on our calendar for SPINRAZA (Nusinersen); 2 FDA decisions are on record below.

What happened at SPINRAZA (Nusinersen)'s most recent FDA decision?

On Mar 30, 2026 the FDA approved the application. The decision page carries the source document and the measured share-price reaction.