Ionis Pharms Inc
1 products tracked · names used in filings: Ionis Pharms Inc, Ionis Pharmaceuticals Inc
Upcoming milestones
No upcoming milestones listed.
Recent milestones
bepirovirsen: PDUFA target action date (chronic hepatitis B)
Ionis Pharmaceuticals Inc (IONS); bepirovirsen; empty; status: set; "and PDUFA target action date of October 26, 2026 o Positive data from the Phase 3 B-Well studies showing unprecedented functional cure rates presented at the European A"; filed 2026-07-29 · source
zilganersen: PDUFA target action date (Alexander disease)
Ionis Pharmaceuticals Inc (IONS); zilganersen; NDA; status: set; "…Zilganersen on track to launch this year as the first and only medicine to demonstrate clinically meaningful and disease-modifying benefit in children and adults with Alexander disease (AxD), assuming approval o New Drug Application (NDA) under FDA Priority Review with PDUFA target action date of September 22,…"; filed 2026-07-29 · source
FDA approves Zanvastro (zilganersen sodium), a new medicine
Ionis Pharms Inc; NDA220210; New molecular entity, Priority review; solution · source
TRYNGOLZA: PDUFA target action date (severe hypertriglyceridemia (sHTG))
Ionis Pharmaceuticals Inc (IONS); olezarsen; sNDA; status: set; "…Olezarsen on track to launch this year as a transformational medicine for severe hypertriglyceridemia (sHTG), assuming approval o sNDA accepted by the FDA for Priority Review for the treatment of sHTG with a Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026 o The European Medicines Agency…"; filed 2026-04-29 · source
SPINRAZA: PDUFA target action date (spinal muscular atrophy (high dose))
Ionis Pharmaceuticals Inc (IONS); nusinersen; empty; status: set; "(PDUFA date of April 3, 2026) o Positive high dose results from pivotal DEVOTE study published in Nature Medicine • WAINUA ® (eplontersen) (WAINZUA"; filed 2026-02-25 · source
Higher dose SPINRAZA: PDUFA target action date (spinal muscular atrophy (SMA))
Ionis Pharmaceuticals Inc (IONS); nusinersen; status: set; "(PDUFA date of September 22, 2025) and in the EU • Biogen to advance salanersen (formerly ION306/BIIB115), an investigational medicine for SMA into regis"; filed 2025-07-30 · source
Donidalorsen: PDUFA target action date (hereditary angioedema (HAE))
Ionis Pharmaceuticals Inc (IONS); donidalorsen; status: set; "PDUFA date of August 21, 2025 o Poised to transform the treatment paradigm for individuals with hereditary angioedema (HAE) as the first and only RNA"; filed 2025-07-30 · source
Products
| Product | Status | Approved | |
|---|---|---|---|
| 🇺🇸 | Zanvastro zilganersen sodium | Approved | 2026-09-03 |
Information from official EMA, FDA, Federal Register and SEC records. Dates marked company-announced come from the company's own SEC filing; dates marked estimate are calculated, not official. Not investment or medical advice; always confirm on the source.