PDUFA date for zilganersen in Alexander disease
The FDA’s decision on Ionis’ Zilganersen for Alexander disease was due on Sep 22, 2026. The outcome isn’t recorded here yet — the linked source has the latest.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Ionis Pharmaceuticals, Inc. IONS
- Drug
- Zilganersen
- For
- Alexander disease
- Stage
- NDA under FDA Priority Review
- When
- Sep 22, 2026
- Source note
- Ionis Q2 2026 earnings release states a PDUFA target action date of September 22, 2026; would be the first approved treatment for Alexander disease.
- Checked
- Checked by a person when it was added
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- IONS headlines on this site
Ionis expects to report results from its Phase 3 study of Pelacarsen for Elevated Lp(a) / cardiovascular risk reduction in the second half of 2026 (no exact date yet). Phase 3 is the last stage before a drug can be approved, so this result usually decides the program’s future.
More details
- Entry
- HORIZON Phase 3 Lp(a) cardiovascular outcomes results for pelacarsen · Clinical trial results (readout / topline data)
- Drug
- Pelacarsen
- For
- Elevated Lp(a) / cardiovascular risk reduction
- Stage
- Phase 3 · the last stage before a drug can be approved
- When
- H2 2026 · the company gave a window, not a day
- Source note
- Ionis Q2 2026 earnings release: Novartis-run HORIZON outcomes trial results anticipated in H2 2026 — the first CVOT readout for an Lp(a)-lowering therapy; major royalty/milestone driver for Ionis.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- IONS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Ionis expects European regulators to decide on TRYNGOLZA (olezarsen) for Severe hypertriglyceridemia during 2027 (no exact date yet). An approval lets the company start selling it in that market.
More details
- Entry
- Potential EU approval/launch of olezarsen for sHTG · Regulatory approval
- Drug
- TRYNGOLZA (olezarsen)
- For
- Severe hypertriglyceridemia
- Stage
- EU MAA (indication extension) under review
- When
- 2027 · the company gave a window, not a day
- Source note
- Q2 2026 earnings PR (Jul 29, 2026): sHTG indication extension for TRYNGOLZA is under EMA review with a potential 2027 launch; no CHMP/EC date given.
- Checked
- Checked by a person when it was added
- Verify it
- Source: biospace.com ↗ — where this entry was taken from
- SEC filings (8-K) ↗ — press releases are attached to 8-K filings
- ClinicalTrials.gov ↗ — trials of this drug
- Drugs@FDA ↗ — search the drug name for approval letters
- IONS headlines on this site
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page