Ionis Pharmaceuticals, Inc.

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.

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• 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

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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.

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• Source: biospace.com ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
• Drugs@FDA ↗ — search the drug name for approval letters
• IONS headlines on this site

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Entry

REVEAL Phase 3 data for obudanersen in Angelman syndrome · Clinical trial results (readout / topline data)

Drug

Obudanersen (ION582)

For

Angelman syndrome

Stage

Phase 3 · the last stage before a drug can be approved

When

H2 2027 · the company gave a window, not a day

Source note

Ionis Q2 2026 earnings release: Phase 3 REVEAL study has completed enrollment with data anticipated in H2 2027.

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• Source: biospace.com ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
• IONS headlines on this site

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Entry

PDUFA date for bepirovirsen in chronic hepatitis B (GSK-partnered) · FDA decision due (PDUFA date)

Drug

Bepirovirsen

For

Chronic hepatitis B

Stage

Under FDA Priority Review

When

Oct 26, 2026

Source note

Ionis Q2 2026 earnings release states a PDUFA target action date of October 26, 2026; GSK leads development/commercialization, with additional regulatory reviews underway in EU, Japan, and China.

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• Source: biospace.com ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
• Drugs@FDA ↗ — search the drug name for approval letters
• IONS headlines on this site

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Entry

PDUFA date for zilganersen in Alexander disease · FDA decision due (PDUFA date)

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.

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• 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

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Entry

ION775 Phase 1 12-month single-dose HTG data oral at ESC Congress 2026 · Data presented at a medical meeting

Drug

ION775 (APOC3 siRNA)

For

Hypertriglyceridemia / sHTG

Stage

Phase 1 · an early safety study in a small group of people

When

Aug 28, 2026

Source note

Aug 20, 2026 Ionis PR: ION775, a long-acting siRNA follow-on to TRYNGOLZA, single-dose 12-month results in moderate hypertriglyceridemia to be presented by Dr. Sotirios Tsimikas at ESC Congress 2026 (Aug 28-31, Munich).

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Entry

TRYNGOLZA CORE-OLE one-year sHTG extension data oral at ESC Congress 2026 · Data presented at a medical meeting

Drug

TRYNGOLZA (olezarsen)

For

Severe hypertriglyceridemia

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 28, 2026

Source note

Aug 20, 2026 Ionis PR: long-term efficacy and safety of olezarsen in sHTG from the CORE/CORE2 open-label extension to be presented by Dr. Robert Giugliano at ESC Congress 2026 in Munich.

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Entry

CARDIO-TTRansform Phase 3 results for eplontersen in ATTR-CM at ESC 2026 · Data presented at a medical meeting

Drug

Eplontersen (WAINUA)

For

Transthyretin amyloid cardiomyopathy (ATTR-CM)

Stage

Phase 3 · the last stage before a drug can be approved

When

Aug 2026 · the company gave a window, not a day

Source note

Per Ionis Q2 2026 earnings release (July 29, 2026), CARDIO-TTRansform outcomes results to be presented at the ESC Congress in late August 2026; AstraZeneca-partnered.

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• ClinicalTrials.gov ↗ — trials of this drug
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Entry

Phase 3 CARDIO-TTRansform missed primary endpoint for eplontersen in ATTR-CM · Clinical trial results (readout / topline data)

Drug

eplontersen (partnered with AstraZeneca)

For

Transthyretin-mediated amyloid cardiomyopathy (ATTR-CM)

Stage

Phase 3 · the last stage before a drug can be approved

When

Jul 9, 2026

Source note

Ionis and AstraZeneca reported that CARDIO-TTRansform failed its primary endpoint of the composite of cardiovascular mortality and recurrent CV events through Week 140 in ATTR cardiomyopathy. A prespecified monotherapy subgroup showed a nominally significant hazard ratio of 0.71, while no treatment effect was seen in patients on a stabilizer at baseline.

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Entry

FDA approves TRYNGOLZA (olezarsen) for severe hypertriglyceridemia · Regulatory approval

Drug

TRYNGOLZA (olezarsen)

For

Severe hypertriglyceridemia (sHTG)

Stage

Regulatory (FDA approval)

When

Jun 24, 2026

Source note

FDA approved TRYNGOLZA (olezarsen) as an adjunct to diet to reduce triglycerides and the risk of acute pancreatitis in adults with severe hypertriglyceridemia, the first and only therapy indicated for pancreatitis risk reduction in sHTG. The approval, based on the Phase 3 CORE and CORE2 studies, is Ionis' first independent launch in a prevalent condition.

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Entry

Olezarsen CORE-OLE liver-fat data at NLA show hepatic fat returning toward baseline · Data presented at a medical meeting

Drug

olezarsen

For

Severe hypertriglyceridemia (sHTG)

Stage

Phase 3 · the last stage before a drug can be approved

When

Jun 12, 2026

Source note

At the National Lipid Association Scientific Sessions, Ionis presented 12-month open-label extension MRI-PDFF data from 53 CORE/CORE2 patients showing mean hepatic fat fraction returning toward baseline after 24 months on olezarsen 80 mg, with a continued favorable safety profile and over 90% retention.

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Entry

Partner GSK's Phase 3 B-Well trials show 19% functional cure rate in hepatitis B · Data presented at a medical meeting

Drug

bepirovirsen (partnered with GSK)

For

Chronic hepatitis B

Stage

Phase 3 · the last stage before a drug can be approved

When

May 28, 2026

Source note

Ionis-partnered bepirovirsen delivered a statistically significant 19% functional cure rate in the pooled B-Well 1 and B-Well 2 Phase 3 trials versus 0% on placebo, meeting the primary endpoints, with 26% cure in patients with HBsAg at or below 1000 IU/mL. Data were published in NEJM and presented at the EASL congress.

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Entry

Zilganersen pivotal AAN 2026 data reinforce benefit; PDUFA set for Sept 22, 2026 · Data presented at a medical meeting

Drug

zilganersen

For

Alexander disease

Stage

Phase 3 · the last stage before a drug can be approved

When

Apr 21, 2026

Source note

Ionis presented additional positive pivotal data for zilganersen in Alexander disease at AAN 2026, with the study meeting its primary endpoint of statistically significant stabilization of gait speed (10-Meter Walk Test) at Week 61 in patients 5 years and older. The release also disclosed a PDUFA target action date of September 22, 2026.

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