Ionis nets Zanvastro US approval in first for Alexander disease

Ionis Pharmaceuticals (IONS) announced FDA approval of ZANVASTRO (zilganersen) for Alexander disease (AxD) in pediatric and adult patients. The treatment is the first to modify the underlying disease mechanism. The approval was based on positive clinical trial results showing stabilization of gait speed and improvement in gross motor function. Ionis will launch the drug in the U.S. and has a license agreement with Recordati for international markets.

Ionis Pharmaceuticals (IONS) announced FDA approval for Zanvastro, a treatment for Alexander disease. The approval was based on clinical trials showing improved gait speed and motor function. The drug will launch in the U.S. soon, with Recordati holding rights outside the U.S. IONS stock is up 2.24% in overnight trading.

Ionis Pharmaceuticals (IONS) received FDA approval for Zanvastro, a treatment for Alexander disease, a rare neurological disorder. The drug showed significant improvement in clinical trials and has no direct competition. Ionis plans to commercialize it independently in the U.S., with peak sales estimated at $295 million. The approval validates Ionis' RNA-targeted drug platform and supports its strategy of independently commercializing neurology medicines.

Ionis Pharmaceuticals (IONS) received FDA approval for Zanvastro, a treatment for Alexander disease. The company trades at a P/S ratio of 10.88, above its historical median, and has a GF Score of 68. Insiders have sold $185.6M in shares, while gurus show mixed activity. GF Value suggests a 20.8% overvaluation.

The FDA approved Ionis Pharmaceuticals' ZANVASTRO (zilganersen) as the first disease-modifying treatment for Alexander disease (AxD) in pediatric and adult patients. The approval was based on positive clinical trial results showing improved motor function. Ionis received a Priority Review Voucher and plans to host a webcast on September 4 to discuss the approval.

Ionis Pharmaceuticals (IONS) received FDA approval for Zanvastro (zilganersen), the first treatment for Alexander disease. Approval was based on a study involving patients aged 2 and older. According to the FDA, this marks a significant milestone in treating the rare neurological disorder.