Intellia Therapeutics, Inc.

Entry

Lonvo-z BLA submission and anticipated FDA acceptance in hereditary angioedema · Company milestone

Drug

Lonvoguran ziclumeran (lonvo-z, NTLA-2002)

For

Hereditary angioedema

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

Q2 2026 PR (Aug 6, 2026): anticipates FDA acceptance of the lonvo-z BLA in H2 2026. HAELO topline (April 27, 2026) was positive: 87% attack-rate reduction vs placebo; first Phase 3 win for in vivo CRISPR editing.

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• Source: globenewswire.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
• NTLA headlines on this site

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Entry

MAGNITUDE-2 Phase 3 enrollment completion (nex-z in ATTRv-PN) · Company milestone

Drug

Nexiguran ziclumeran (nex-z, NTLA-2001)

For

Hereditary ATTR amyloidosis with polyneuropathy

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 successfully reinitiated in the nex-z Phase 3 trials (MAGNITUDE and MAGNITUDE-2); MAGNITUDE-2 enrollment completion expected in H2 2026.

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• Source: globenewswire.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
• NTLA headlines on this site

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

Entry

Anticipated U.S. approval/launch of lonvo-z in hereditary angioedema · Regulatory approval

Drug

Lonvoguran ziclumeran (lonvo-z, NTLA-2002)

For

Hereditary angioedema

Stage

BLA (planned)

When

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

Source note

Company plans a U.S. launch in H1 2027, implying an FDA decision in that window. No PDUFA date assigned yet (BLA not yet accepted as of Aug 20, 2026).

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• Source: globenewswire.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
• NTLA headlines on this site

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

Entry

Additional positive Phase 3 HAELO data at EAACI 2026; NEJM publication · Data presented at a medical meeting

Drug

lonvoguran ziclumeran (lonvo-z, NTLA-2002)

For

Hereditary angioedema (HAE)

Stage

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

When

Jun 13, 2026

Source note

Intellia presented additional positive Phase 3 HAELO results for lonvo-z in a late-breaking oral session at EAACI 2026 in Istanbul, with simultaneous publication in the New England Journal of Medicine. Benefit was consistent regardless of age or prior long-term prophylaxis.

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• Source: stocktitan.net ↗ — where this entry was taken from
• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• NTLA headlines on this site

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

Entry

Phase 3 HAELO met primary endpoint: 87% cut in HAE attacks with lonvo-z · Clinical trial results (readout / topline data)

Drug

lonvoguran ziclumeran (lonvo-z, NTLA-2002)

For

Hereditary angioedema (HAE)

Stage

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

When

Apr 27, 2026

Source note

The global Phase 3 HAELO trial of lonvoguran ziclumeran (lonvo-z, formerly NTLA-2002) met its primary and all key secondary endpoints, with an 87% reduction (p<0.0001) in mean monthly hereditary angioedema attacks; 62% of treated patients were attack- and therapy-free over the six-month efficacy period versus 11% on placebo.

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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
• NTLA headlines on this site

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

Entry

First-ever in vivo CRISPR editing clinical data · Clinical trial results (readout / topline data)

Drug

NTLA-2001 (nex-z)

For

ATTR amyloidosis

Stage

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

When

Jun 26, 2021

Source note

NTLA-2001 interim Phase 1 data in ATTR amyloidosis showed deep TTR knockdown.

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• SEC filings (8-K) ↗ — press releases are attached to 8-K filings
• ClinicalTrials.gov ↗ — trials of this drug
• NTLA headlines on this site

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