Ionis Pharmaceuticals Inc., IONS, FDA Calendar, PDUFA Date

Company Name	Ionis Pharmaceuticals, Inc. IONS
Drug Name	Nusinersen (sNDA)
Event Name	FDA decision on high-dose regimen of nusinersen for people living with spinal muscular atrophy (SMA)
Event Date	04/03/2026
Outcome Date
Outcome	pending
Drug Status	Biogen holds global license to develop, manufacture, and commercialize SPINRAZA (nusinersen) from Ionis Pharmaceuticals
Rival Drugs
Market Potential
Other Approvals	SPINRAZA (nusinersen) was approved by the FDA on December 23, 2016, as the first treatment for Spinal Muscular Atrophy (SMA) in pediatric and adult patients.
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