Lonvo-z BLA submission and anticipated FDA acceptance in hereditary angioedema
Lonvo-z BLA submission and anticipated FDA acceptance in hereditary angioedema, expected in the second half of 2026 (no exact date yet). A company milestone for Intellia (Lonvoguran ziclumeran (lonvo-z, NTLA-2002) for Hereditary angioedema): 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
- Intellia Therapeutics, Inc. NTLA
- 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; the calendar never invents one
- 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.
- Checked
- Checked by a person when it was added
- 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
MAGNITUDE-2 Phase 3 enrollment completion (nex-z in ATTRv-PN), expected in the second half of 2026 (no exact date yet). A company milestone for Intellia (Nexiguran ziclumeran (nex-z, NTLA-2001) for Hereditary ATTR amyloidosis with polyneuropathy): a step in the program rather than a decision or a data readout.
More details
- 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.
- Checked
- Checked by a person when it was added
- Verify it
- 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
Intellia expects regulators to decide on Lonvoguran ziclumeran (lonvo-z, NTLA-2002) for Hereditary angioedema in the first half of 2027 (no exact date yet). An approval lets the company start selling it in that market.
More details
- 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).
- Checked
- Checked by a person when it was added
- Verify it
- 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