Intellia Therapeutics, Inc. NTLA
Intellia Therapeutics, Inc. (Nasdaq: NTLA) is a rare genetic drug developer. Its lead program, lonvoguran ziclumeran (lonvo-z), is in Phase 3 for hereditary angioedema (HAE). Its next catalyst on record is lonvoguran ziclumeran (lonvo-z): PDUFA target action date (March 2027).
Upcoming catalysts
- March 2027lonvoguran ziclumeran (lonvo-z) — PDUFA target action date
In September 2026, the FDA accepted the BLA for lonvo-z and granted the BLA Priority Review with a Prescription Drug User Fee Act ('PDUFA') target action date of March 10, 2027.
Next further out: lonvoguran ziclumeran (lonvo-z) — Planned commercial launch (Q1 2027). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| lonvoguran ziclumeran (lonvo-z) | hereditary angioedema (HAE) | gene therapy | Phase 3 |
| nexiguran ziclumeran (nex-z) | ATTR amyloidosis with cardiomyopathy (ATTR-CM) | gene therapy | Phase 3 |
| nexiguran ziclumeran (nex-z) | hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) | gene therapy | Phase 3 |
Recent results and decisions
- Sep 30, 2026accepted FDA accepted BLA for lonvo-z for HAE with Priority Review and PDUFA date of March 10, 2027.
In September, the U.S. Food and Drug Administration (FDA) accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a Prescription Drug User Fee Act (PDUFA) target action date of March 10, 2027.
Filing - Sep 30, 2026completed enrollment Completed enrollment in MAGNITUDE-2 Phase 3 trial in ATTRv-PN, exceeding targeted randomization of 60 patients.
During the third quarter, the company completed enrollment in its MAGNITUDE-2 Phase 3 clinical trial in hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), exceeding its targeted randomization of 60 patients.
Filing - Sep 8, 2026accepted FDA accepted lonvo-z BLA with Priority Review; PDUFA date March 10, 2027; no AdComm currently planned.
FDA has accepted the Biologics License Application (BLA) for lonvo-z and granted the BLA Priority Review with a PDUFA target action date of March 10, 2027.
Filing
5 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 rare genetic companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.