Biotech Tracker
MilestoneApr 24, 2026186 days ago

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

CHMP positive opinion recommends EU approval of REDEMPLO (plozasiran) in FCS, on Apr 24, 2026. A company milestone for Arrowhead (REDEMPLO (plozasiran) for Familial chylomicronemia syndrome (FCS)): a step in the program rather than a decision or a data readout.

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DetailsCompany milestone
Company
Arrowhead Pharmaceuticals, Inc. ARWR
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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Arrowhead Pharmaceuticals, Inc.
ARWR
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MilestoneARWRArrowheadH2 2026

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.

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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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Trial resultsARWRArrowheadH2 2026

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.

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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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Trial resultsARWRArrowheadQ4 2026

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.

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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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MilestoneARWRArrowheadH1 2027

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.

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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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MilestoneARWRArrowheadQ2 2027

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.

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