Ionis gains approval of zilganersen for Alexander disease (NASDAQ:IONS)

Ionis Pharmaceuticals (IONS) received FDA approval for Zanvastro, a treatment for Alexander disease, ahead of the expected date. The drug, backed by positive phase III study results, is the first disease-modifying treatment for this rare neurological condition. Ionis shares have fallen 27% year-to-date, and the company also received a rare pediatric disease priority review voucher, which could provide additional value.

Ionis Pharmaceuticals received FDA approval for Zanvastro (zilganersen), a therapy for Alexander disease. The drug showed efficacy in stabilizing walking speed in patients aged five and older. Ionis plans to launch Zanvastro in the US soon, with Recordati holding ex-US rights. The company has not yet disclosed the drug's price.

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.