Record mula sa primary source
MateryalNaitakda ang petsa ng PDUFA
Ionis: zilganersen PDUFA itinakda sa Setyembre 22, 2026
Itinakda ng FDA ang PDUFA action date na Setyembre 22, 2026 para sa zilganersen sa ilalim ng Priority Review. Ipinakikita rin ng press release ang karagdagang positibong pivotal-study data sa mga motor, patient-reported at clinician-reported endpoints na sumusuporta sa dating inihayag na topline results.
Mahahalagang fact
- Na-file
- Abr 21, 2026, 11:00 AM
- Kaganapan
- Naitakda ang petsa ng PDUFA
- Direksyon
- Positibo
- Kumpanya
IONSIonis- Asset
- zilganersen
- Pinagmulan
- SEC 8-K
- Kumpiyansa
- May source
- Kalendaryo
- Desisyon ng FDA (PDUFA) · Set 22, 2026 · Positibo
- P-value ng GFAP
- 0.003
- P-value ng 10MWT
- 0.041
- P-value ng GMFM-88
- 0.034
- Pagbawas ng GFAP
- 33.6%
- Pagkakaiba sa 10MWT
- 33.3%
- Pagkakaiba sa GMFM-88
- 22.9 puntos
Sipi mula sa source
EX-99.1 2 ef20071051_ex99-1.htm EXHIBIT 99.1 Exhibit 99.1 FINAL: April 20, 2026 Ionis presents new data from pivotal study of zilganersen in Alexander disease (AxD) at AAN 2026 Annual Meeting – New data highlight potential treatment benefit across multiple AxD symptom domains, reinforcing zilganersen’s positive impact on people living with this rare, often fatal neurological disease – – PDUFA date set for September 22, 2026 – CARLSBAD, Calif., April 21, 2026 -- Ionis Pharmaceuticals, Inc. (Nasdaq: IONS) today announced additional positive results from the pivotal study of zilganersen in children and adults living with Alexander disease (AxD), a rare, progressive and often fatal neurological condition with no approved disease-modifying treatments. These findings, which will be prese