Name in SEC filings: IONIS PHARMACEUTICALS INC
| Program | Event | Stage | Stated timing | Filing |
|---|---|---|---|---|
| olezarsen | submission | Phase 3 | by the end of the year | 8-K · |
| zilganersen | NDA/BLA submission | — | in 2026 | 8-K · |
| olezarsen | target date (company stated) | PDUFA | June 30, 2026 | SEC filing · |
| zilganersen | PDUFA target date (company stated) | PDUFA | September 22, 2026 | SEC filing · |
| bepirovirsen | PDUFA target date (company stated) | PDUFA | October 26, 2026 | SEC filing · |
| pelacarsen | /data readout | Stage not stated | 2026 | 8-K · |
| sefaxersen | Topline/data readout | Stage not stated | 2026 | 8-K · |
| ulefnersen | Topline/data readout | Stage not stated | 2026 | 8-K · |
Source: ORION, orionbiotechai.com/company/IONS, data as of Oct 18, 2026
https://www.orionbiotechai.com/company/IONS
bepirovirsen · PDUFA target date (company stated) · October 26, 2026
SEC sources last checked .
○ Quote matched to filing (not yet reviewed by founder) · ✓ Checked by founder.
severe hypertriglyceridemia
NDA/BLA submissionby the end of the year
Stage: Phase 3SEC filing · “Phase 3”
Public float: $5,275,488,712 · as of · SEC filing
Ionis is on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the FDA by the end of the year.
8-K · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2025-12)
Alexander disease
NDA/BLA submissionin Q1 2026
Stage: —
Public float: $5,275,488,712 · as of · SEC filing
Planned NDA submission in Q1 2026
8-K · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-03)
severe hypertriglyceridemia
PDUFA target date (company stated)June 30, 2026
Stage: PDUFASEC filing · “PDUFA) target action date”
Public float: $5,275,488,712 · as of · SEC filing
Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-06)
Alexander disease
PDUFA target date (company stated)September 22, 2026
Stage: PDUFASEC filing · “PDUFA target action date”
Public float: $5,275,488,712 · as of · SEC filing
PDUFA target action date of September 22, 2026
SEC filing · Filed · Last checked
Resolution filing: · SEC filing
Alert me · Calendar: same stage and window-end month (2026-09)
chronic hepatitis B
PDUFA target date (company stated)October 26, 2026
Stage: PDUFASEC filing · “PDUFA target action date”
Public float: $5,275,488,712 · as of · SEC filing
PDUFA target action date of October 26, 2026
SEC filing · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-10)
Topline/data readout2026
Stage: Not stated
Public float: $5,275,488,712 · as of · SEC filing
Pelacarsen Lp(a)-CVD Lp(a) HORIZON data •
SEC timing legend:
• Indicates that the milestone is anticipated in 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readout2026
Stage: Not stated
Public float: $5,275,488,712 · as of · SEC filing
Sefaxersen IgAN IMAGINATION data •
SEC timing legend:
• Indicates that the milestone is anticipated in 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Topline/data readout2026
Stage: Not stated
Public float: $5,275,488,712 · as of · SEC filing
Ulefnersen FUS-ALS FUSION data •
SEC timing legend:
• Indicates that the milestone is anticipated in 2026.
8-K · Filed · Last checked
Alert me · Calendar: same stage and window-end month (2026-12)
Company periods and sentences are quoted as written. A matching disclosure uses the SEC filing date for the same program and event type. As of .
| Program / event | Stated period and SEC wording | Disclosure in stated period |
|---|---|---|
| bepirovirsenFDA decision | October 26, 2026“PDUFA target action date of October 26, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| bepirovirsenFDA decision | October 26, 2026“PDUFA action date of October 26, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| pelacarsenClinical results | 2026“Pelacarsen Lp(a)-CVD Lp(a) HORIZON data •” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| sefaxersenClinical results | 2026“Sefaxersen IgAN IMAGINATION data •” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| ulefnersenClinical results | 2026“Ulefnersen FUS-ALS FUSION data •” Filed · EX-99.1 | Still within period As of Oct 19, 2026 |
| zilganersenFDA decision | September 22, 2026“PDUFA target action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“Prescription Drug User Fee Act, or PDUFA, action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| bepirovirsenFDA decision | October 26, 2026“PDUFA action date of October 26, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| bepirovirsenFDA decision | October 26, 2026“PDUFA date of October 26, 2026” Filed · SEC original | Period not started The stated period has not started yet, so there is nothing to compare. |
| olezarsenFDA decision | June 30, 2026“Prescription Drug User Fee Act (PDUFA) target action date of June 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| olezarsenFDA decision | June 30, 2026“Prescription Drug User Fee Act, or PDUFA, action date of June 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“PDUFA action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“PDUFA target action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“Prescription Drug User Fee Act (PDUFA) action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“PDUFA date set for September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenFDA decision | September 22, 2026“Prescription Drug User Fee Act action date of September 22, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| olezarsenFDA decision | June 30, 2026“action date of June 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| olezarsenFDA decision | June 30, 2026“PDUFA action date of June 30, 2026” Filed · SEC original | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| zilganersenSubmission | in Q1 2026“Planned NDA submission in Q1 2026” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| olezarsenFDA decision | 2026“expect a Prescription Drug User Fee Act (“PDUFA”) target action date in 2026” Filed · SEC original | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by the end of the year“Ionis is on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the FDA by the end of the year.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by the end of the year“We are on track to submit a supplemental new drug application for both the 50 mg and 80 mg doses to the U.S. Food and Drug Administration (“FDA”) by the end of the year” Filed · 8-K | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | the end of 2025“sNDA submission on track for the end of 2025” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by year-end“sNDA submission on track by year-end” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| zilganersenSubmission | in Q1 2026“NDA submission planned in Q1 2026” Filed · EX-99.1 | Not compared The stated period has ended. ORION has no record of a complete search of SEC filings from that period. |
| olezarsenSubmission | by end of year“sNDA submission planned by end of year” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by end of year“Ionis plans to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration by end of year.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by end of year“We plan to submit a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration by end of year.” Filed · 8-K | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
| olezarsenSubmission | by year-end“which will be the basis for our potential sNDA filing in sHTG by year-end.” Filed · EX-99.1 | Not compared ORION has no confirmed start and end dates for this wording, so it is not compared with filings. |
“Not compared” means ORION has not matched this wording against a complete set of SEC filings for its period. It says nothing either way about whether a matching filing exists. Wording without exact dates is not given calendar dates.
Historical summaries and source dates are retained separately from the SEC timing quotes above. Earlier publications were collected retrospectively.
Historical catalog checked .
Source published · Original announcement
Retained timing label: 2024-12-19
Retained summary: Ionis reported a December 19, 2024 FDA target action date for olezarsen in familial chylomicronemia syndrome. Other olezarsen indications and their trials are separate milestones.
Source published · Original announcement
Retained summary: Ionis announced FDA approval of TRYNGOLZA as an adjunct to diet for adults with familial chylomicronemia syndrome.
Original ClinicalTrials.gov record · Open the selected study
These are selected linked records and dated source metadata, not a live registry recheck or the company’s full pipeline. Company announcements and the selected registry study are separate evidence sets. No stage or event timing is borrowed between them.
Coverage and identity checksSuggest an SEC timing statement to add for IONS. You can include the original filing link in your note. The founder reads each request by hand.
Or email ORION.
See IONS in the calendar · Review labels and methodology