Intellia’s Lonvo-z Cuts Attacks 87%, Initiates BLA Submission and Raises $207M
Intellia’s Phase 3 HAELO trial of lonvo-z cut hereditary angioedema attacks by 87% versus placebo over six months with favorable safety, prompting a rolling BLA submission targeting potential U.S. approval in H1 2027. The company raised $207 million in April and held $517.2 million in cash at quarter-end, funding operations into 2028.
1. Phase 3 HAELO Topline Results
Intellia reported positive topline results from its global Phase 3 HAELO trial of lonvo-z in hereditary angioedema, with a one-time infusion reducing attack rates by 87% versus placebo over six months (0.26 vs. 2.10 mean monthly attacks, p<0.0001) and meeting all key secondary endpoints.
2. Rolling BLA Submission and Timeline
Following the HAELO success, the company initiated a rolling biologics license application to the FDA under RMAT designation, planning to submit remaining data in H2 2026 to support a potential U.S. launch in H1 2027.
3. nex-z Phase 3 Trial Resumption
Intellia resumed patient screening in its Phase 3 MAGNITUDE and MAGNITUDE-2 trials of nexiguran ziclumeran (nex-z) for ATTR-CM and ATTRv-PN after the FDA lifted clinical holds, aiming to complete MAGNITUDE-2 enrollment in H2 2026.
4. Financial Position and Runway
At March 31, cash, equivalents and marketable securities totaled $517.2 million, and an April public offering raised approximately $207 million, providing funding through at least 2028 to support continued development and operations.