Potential accelerated Redemplo sHTG launch Q2 2027 (PRV priority review)
Potential accelerated Redemplo sHTG launch Q2 2027 (PRV priority review), expected in Q2 2027 (Apr–Jun) (no exact date yet). A company milestone for Arrowhead (plozasiran (Redemplo) for Severe hypertriglyceridemia): a step in the program rather than a decision or a data readout.
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary
- Company
- Arrowhead Pharmaceuticals, Inc. ARWR
- Drug
- plozasiran (Redemplo)
- For
- Severe hypertriglyceridemia
- Stage
- sNDA
- When
- Q2 2027 · the company gave a window, not a day; the calendar never invents one
- 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
sNDA submission to FDA for plozasiran in severe hypertriglyceridemia, expected in the second half of 2026 (no exact date yet). A company milestone for Arrowhead (Plozasiran (Redemplo) for Severe hypertriglyceridemia): a step in the program rather than a decision or a data readout.
More details
- 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
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Arrowhead expects to report results from its Phase 3 study of Plozasiran (Redemplo) for Mixed hyperlipidemia (supportive for sHTG filing) 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
- 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
Plain-English summary generated from this entry’s own fields (drug, condition, stage, date). Glossary · Open this catalyst’s page
Arrowhead expects to report results from its Phase 1/2 study of ARO-ALK7 for Obesity in Q4 2026 (Oct–Dec) (no exact date yet). Phase 1/2 is an early study that checks safety and takes a first look at effect.
More details
- 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
- 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
Zodasiran Ph3 YOSEMITE HoFH study completion mid-2027, expected in the first half of 2027 (no exact date yet). A company milestone for Arrowhead (zodasiran for Homozygous familial hypercholesterolemia): a step in the program rather than a decision or a data readout.
More details
- 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
- 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