Arrowhead Pharmaceuticals, Inc.

Entry

sNDA submission to FDA for plozasiran in severe hypertriglyceridemia · Company milestone

Drug

Plozasiran (Redemplo)

For

Severe hypertriglyceridemia

Stage

Regulatory submission

When

H2 2026 · the company gave a window, not a day

Source note

Company PR (July 22, 2026): planned sNDA with U.S. FDA 'before the end of 2026,' leveraging SHASTA-3, SHASTA-4 and MUIR-3, with additional global filings to follow. A PDUFA date would follow acceptance (not yet assigned).

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• Source: businesswire.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
• ARWR headlines on this site

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Entry

MUIR-3 Phase 3 topline: plozasiran in mixed hyperlipidemia · Clinical trial results (readout / topline data)

Drug

Plozasiran (Redemplo)

For

Mixed hyperlipidemia (supportive for sHTG filing)

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

Enrollment-completion PR guided primary completion of SHASTA-3/4 and MUIR-3 in mid-2026 'with topline data expected shortly thereafter.' SHASTA-3/4 topline is out (July 2026); MUIR-3 topline had not been published as of Aug 20, 2026. H2 2026 window inferred from that company guidance.

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• Source: ir.arrowheadpharma.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
• ARWR headlines on this site

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Entry

ARO-ALK7 additional Ph1/2 obesity data in Q4 2026 · Clinical trial results (readout / topline data)

Drug

ARO-ALK7

For

Obesity

Stage

Phase 1/2 · an early study that checks safety and takes a first look at effect

When

Q4 2026 · the company gave a window, not a day

Source note

Fiscal Q3 2026 call (Aug 4, 2026). Management also flagged additional obesity-program updates in Q4; ARO-INHBE Phase 2b protocol submitted to regulators with start timing pending.

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• Source: investing.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
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Entry

Zodasiran Ph3 YOSEMITE HoFH study completion mid-2027 · Company milestone

Drug

zodasiran

For

Homozygous familial hypercholesterolemia

Stage

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

When

H1 2027 · the company gave a window, not a day

Source note

Fiscal Q3 2026 release (Aug 4, 2026); enrollment completed mid-July 2026. 'mid-2027' mapped to 2027-H1; management said on the call that data follow in H2 2027 (outside this window).

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• Source: biospace.com ↗ — where this entry was taken from
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Entry

Potential accelerated Redemplo sHTG launch Q2 2027 (PRV priority review) · Company milestone

Drug

plozasiran (Redemplo)

For

Severe hypertriglyceridemia

Stage

sNDA

When

Q2 2027 · the company gave a window, not a day

Source note

Fiscal Q3 2026 call (Aug 4, 2026): sNDA to be filed before year-end 2026 using an acquired priority review voucher (6-month review), which management said could enable an sHTG launch in Q2 2027. No PDUFA date yet.

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• Source: finance.yahoo.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
• ARWR headlines on this site

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Entry

ARO-DIMER-PA Ph1 early data (APOC3/PCSK9 dimer) in September · Clinical trial results (readout / topline data)

Drug

ARO-DIMER-PA

For

Mixed hyperlipidemia / cardiometabolic

Stage

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

When

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

Source note

Management guidance on the fiscal Q3 2026 call (Aug 4, 2026), per Investing.com transcript. Earlier guidance (fiscal Q2 call) put ARO-DIMER-PA in Q3 2026.

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• Source: investing.com ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
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Entry

ARO-MAPT Ph1 healthy-volunteer early data (tau knockdown) in September · Clinical trial results (readout / topline data)

Drug

ARO-MAPT

For

Alzheimer's disease / tauopathies

Stage

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

When

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

Source note

Fiscal Q3 2026 call (Aug 4, 2026) highlights via Yahoo Finance; first CNS (intrathecal) program data. Prior guidance was late Q3/early Q4 2026.

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• Source: finance.yahoo.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
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Entry

SHASTA-3/SHASTA-4 detailed Phase 3 results, ESC Congress HOT LINE late-breaker · Data presented at a medical meeting

Drug

Plozasiran (Redemplo)

For

Severe hypertriglyceridemia

Stage

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

When

Aug 30, 2026

Source note

Topline (July 22, 2026) was positive: ~79-81% median TG reduction, significant acute pancreatitis reduction. Detailed results to be presented as a HOT LINE Late Breaker at the European Society of Cardiology Congress, Munich, on August 30, 2026.

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• Source: businesswire.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
• ARWR headlines on this site

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Entry

EC grants EU marketing authorization for REDEMPLO (plozasiran) in FCS · Regulatory approval

Drug

REDEMPLO (plozasiran)

For

Familial chylomicronemia syndrome (FCS)

Stage

Regulatory (EC decision)

When

Jun 22, 2026

Source note

The European Commission formally granted marketing authorization for REDEMPLO (plozasiran) to reduce triglycerides in adults with familial chylomicronemia syndrome, making it the first and only siRNA medicine authorized in the EU for FCS.

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• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
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Entry

Australia's TGA approves REDEMPLO (plozasiran) for FCS · Regulatory approval

Drug

REDEMPLO (plozasiran)

For

Familial chylomicronemia syndrome (FCS)

Stage

Regulatory (TGA)

When

May 1, 2026

Source note

Australia's Therapeutic Goods Administration approved REDEMPLO (plozasiran) for familial chylomicronemia syndrome, the first and only medicine approved for FCS in Australia, for both genetically confirmed and clinically diagnosed adults.

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• Source: biospace.com ↗ — where this entry was taken from
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• ClinicalTrials.gov ↗ — trials of this drug
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Entry

CHMP positive opinion recommends EU approval of REDEMPLO (plozasiran) in FCS · Company milestone

Drug

REDEMPLO (plozasiran)

For

Familial chylomicronemia syndrome (FCS)

Stage

Regulatory (EU MAA)

When

Apr 24, 2026

Source note

The EMA's CHMP adopted a positive opinion recommending approval of REDEMPLO (plozasiran) as an adjunct to diet to reduce triglycerides in adults with familial chylomicronemia syndrome, covering both genetically confirmed and clinically diagnosed patients.

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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
• ARWR headlines on this site

Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page