Intellia Completes 80-Patient Phase 3 HAE Trial, $605M Cash Fuels 2027 Runway
Intellia Therapeutics completed enrollment of 80 patients in its phase 3 HAELO trial nine months after first dosing and holds $605 million cash funding operations into H2 2027. FDA lifted the hold on its MAGNITUDE-2 ATTR study as top-line HAELO data are expected by mid-2026 and BLA submission planned H2 2026.
1. Phase 3 HAELO Trial Progress
Intellia completed enrollment of 80 patients in its phase 3 HAELO trial in September 2025, nine months after dosing the first patient. The company expects top-line data by mid-2026 and plans a BLA submission in the second half of 2026 for its one-time gene-editing candidate lonvo-z.
2. Financial Position
As of December 31, 2025, Intellia held $605.1 million in cash, providing a runway into the second half of 2027. Collaboration revenue increased in Q4 while net loss narrowed to $95.8 million, reflecting operating leverage across its in vivo platforms.
3. ATTR Program Update
The FDA lifted the clinical hold on Intellia’s MAGNITUDE-2 ATTR polyneuropathy study after adding liver monitoring, steroid guidance and tighter screening criteria. The cardiomyopathy arm of the program remains on hold pending further regulatory review.
4. Commercial Readiness for lonvo-z
Intellia is scaling its field medical team, engaging payers and patient groups, and finalizing distribution models and pricing strategy for a potential one-time HAE therapy launch. The company is identifying U.S. treatment centers and building reimbursement teams ahead of anticipated approval.