Earnings Releases·Nov 12, 2026, 4:14 PM ET

Intellia Therapeutics — November 12, 2026 Earnings Summary

FDA accepted the Biologics License Application (BLA) for lonvo-z for hereditary angioedema (HAE) for priority review, with a PDUFA goal date of March 10, 2027; no advisory committee meeting is currently planned.
Phase 3 HAELO trial results met all primary and key secondary endpoints, demonstrating a 62% mean attack-rate reduction and 87% reduction in attack-free weeks versus placebo, with 100% of patients achieving long-term prophylaxis (LTP) freedom.
The company is preparing for a commercial launch in March 2027, having established a dedicated team, engaged payers covering 280M+ U.S. lives, and built an Authorized Treatment Center (ATC) network with a "buy-and-bill" model to mitigate funding exposure.
First revenue generation is projected between months 3-6 post-approval, supported by strong physician interest (88% of surveyed HCPs would prescribe within one year) and a clear preference advantage over clinical-stage competitors.
No specific financial performance metrics, revenue figures, or guidance changes were disclosed in the summary; the outlook remains focused on the successful execution of the one-time therapy launch.