Ionis gets $30 million Recordati deal

• Ionis signed a license agreement giving Recordati exclusive zilganersen rights outside the U.S.
• Ionis receives $30 million upfront and may receive milestones plus tiered royalties.
• Ionis will keep U.S. responsibility as zilganersen moves toward a September 22 FDA decision date.

Ionis Pharmaceuticals (NASDAQ:IONS) entered a license agreement giving Recordati (BIT) exclusive rights to develop and commercialize zilganersen outside the U.S., with Ionis receiving $30 million upfront.

The deal comes as Ionis prepares for a possible U.S. launch, with zilganersen under FDA review and a PDUFA action date of September 22, 2026.

“Together, we are committed to working closely to help bring zilganersen to people living with Alexander disease outside the United States,” said Ionis chief executive officer Brett P. Monia.

Recordati will handle regulatory filings and commercialization outside the U.S., while Ionis will lead global development and keep sole commercial responsibility in the U.S.

Following the announcement, Ionis' share price was up at $76.52.

Ionis said zilganersen 50 mg met the primary endpoint in patients aged at least 5 years, showing gait speed stabilization on the 10-Meter Walk Test at Week 61 versus control.

Ionis also said most adverse events were mild or moderate, while serious treatment-emergent adverse events occurred in 37.5% of zilganersen 25 mg or 50 mg patients and 47.1% of pooled control patients.