Ionis and Roche report positive Phase 3 interim data for sefaxersen in IgA nephropathy
The IMAgINATION study hit its primary endpoint at 37 weeks, with the trial continuing blinded to assess kidney function through week 105.
SEC filing
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The IMAgINATION study hit its primary endpoint at 37 weeks, with the trial continuing blinded to assess kidney function through week 105.
SEC filing
The moves are meant to expand AI use across ProQR's Axiomer RNA editing programs, with an early readout for lead AI-discovered candidate AX-0811 expected in January 2027.
SEC filing
Lp(a)HORIZON did not reduce cardiovascular events despite lowering Lp(a) levels, Ionis and partner Novartis reported.
SEC filing
The agency cleared zilganersen as the first disease-modifying therapy for the ultra-rare neurological disorder and awarded Ionis a Rare Pediatric Disease Priority Review Voucher.
SEC filing
Records show the approval letter and label were issued days after the FDA's September 3 clearance of Ionis Pharmaceuticals' zilganersen.
Drugs@FDA, FDA press release (2)
TRYNGOLZA and DAWNZERA launches build early momentum as Ionis awaits zilganersen approval, an Lp(a) outcomes readout, and a hepatitis B launch.
SEC filing