# Lonvoguran ziclumeran (lonvo-z; formerly NTLA-2002) PDUFA Event: Hereditary angioedema

Canonical URL: https://biopharmsignal.com/pdufa-calendar/NTLA/lonvoguran-ziclumeran-hereditary-angioedema

Ticker: NTLA

Company: Intellia

Event date: 2027-03-10

Event type: FDA Decision

Stage: PDUFA

Result: Pending

Application type: BLA

FDA decision expected. FDA granted Priority Review and set March 10, 2027 as the PDUFA target action date for the lonvo-z BLA.

## Event Timeline

### March 10, 2027 — FDA decision expected

FDA granted Priority Review and set March 10, 2027 as the PDUFA target action date for the lonvo-z BLA.

[Intellia — BLA acceptance, Priority Review and PDUFA date](https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm)

### September 8, 2026 — FDA accepted the BLA for review

FDA accepted Intellia's BLA for lonvo-z, a one-time in vivo CRISPR-based treatment candidate for hereditary angioedema, and indicated that no advisory committee meeting was then planned.

[Intellia — FDA acceptance announcement](https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm)

### January 2026 — Phase 3 HAELO data supported the rolling BLA

Intellia reported positive Phase 3 HAELO results for lonvo-z and used those data to support its rolling BLA submission.

[Intellia — HAELO Phase 3 update](https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm)

## Regulatory Designations

- Priority Review FDA: [Intellia — BLA acceptance and Priority Review](https://www.sec.gov/Archives/edgar/data/1652130/000119312526385194/ntla-ex99_1.htm)

## Related Pages

- NTLA PDUFA calendar: https://biopharmsignal.com/pdufa-calendar/NTLA.md

- NTLA company profile: https://biopharmsignal.com/company/NTLA.md

- PDUFA calendar: https://biopharmsignal.com/pdufa-calendar.md

## Related News

- 2026-10-02 — Intellia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/NTLA/intellia-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635-c-240d5c46.md

- 2026-10-02 — Intellia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/NTLA/intellia-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635-c-c6e6fb53.md

- 2026-09-08 — Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE): https://biopharmsignal.com/news/NTLA/intellia-therapeutics-announces-fda-acceptance-of-biologics-license-application--19e36b7c.md

- 2026-09-08 — Intellia Therapeutics Announces FDA Acceptance of Biologics License Application with Priority Review for Lonvoguran Ziclumeran (Lonvo-z) for Hereditary Angioedema (HAE): https://biopharmsignal.com/news/NTLA/intellia-therapeutics-announces-fda-acceptance-of-biologics-license-application--21eb726f.md

- 2026-09-04 — Intellia Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4): https://biopharmsignal.com/news/NTLA/intellia-therapeutics-reports-inducement-grants-under-nasdaq-listing-rule-5635-c-250d5dd9.md