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Newswires & Feeds Content Syndication Digital Signage Services Radio News Services Intelligent Investor Biotech Investor Latest News Videos Free Content Press Releases Clinical Trial Results Ionis Enters Licensing Deal With Recordati For Zilganersen Commercialization In Alexander Disease By RTTNews Staff Writer ✉ | Published: 6/25/2026 6:48 AM ET Addas your preferred news source on Google Ionis Pharmaceutical Inc. (IONS), a commercial-stage biotechnology company, on Thursday announced entering a license agreement with Recordati (REC.MI), a pharmaceutical company, for the international commercialization rights of Zilganersen in treating
Alexander disease. According to the terms of the agreement, Ionis will retain all commercialization rights for Zilganersen within the U.S. The company will receive an upfront payment of $30 million, in addition to various milestone payments and up to 20% in royalties on potential net sales of the drug. Recordati assumes responsibility for all regulatory filing and commercialization outside the U.S. Alexander disease (AxD) is a rare, progressive, and ultimately fatal neurological disorder that affects one in every 1 to 3 million individuals. The disorder
affects patients’ astrocytes, which support neurons in the brain, and can be modified by variations in the GFAP genes. The disease currently has no cure. Zilganersen is an investigational, antisense, oligonucleotide RNA- targeting therapy. The drug inhibits excess production of the glial fibrillary acidic protein (GFAP), to restore the function of astrocytes in patients of AxD. Zilganersen was granted a Breakthrough Therapy, Fast Track and Rare Pediatric Disease designations by the U.S. Food and Drug Administration (FDA), in addition to an Orphan Drug designation from
both the FDA and European Medicines Agency (EMA). Positive data from the Phase 1-3 pivotal study for Zilganersen in AxD was reported by the company. The study demonstrated a meaningful stabilization of gait speed in treated patients, measured by the 10 meter walk test (10MWT), used to determine gross motor function at week 61. Currently under a priority review by the FDA, a prescription drug user fee act date (PDUFA) for Zilganersen was set at September 22, 2026. If approved, the drug will be the
first and only treatment for AxD. IONS closed Wednesday at $76.52, up 0.70%. In the pre-market, shares are trading at $77.65. up 1.48%. REC.MI is currently trading on the Milan Stock Exchange at EUR 51.53, down 0.05%. For comments and feedback contact: editorial@rttnews.com Slide Shows Biotech Stocks Facing FDA Decision In June 2026 Biotech Stocks Facing FDA Decision In May 2026 Biotech Stocks Facing FDA Decision In April 2026 Latest Updates on Middle East War Canadian Stocks Slide Amid U.S.-Iran Disagreements, Declines In Gold, Silver
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Ionis, Recordati, Zilganersen, Alexander disease, AxD, licensing agreement, FDA priority review, PDUFA September 22 2026, breakthrough therapy, Fast Track, orphan drug