Intellia Therapeutics Inc. (NTLA), a biopharmaceutical company, on Saturday released additional positive results from the Phase 3 HAELO trial for Lonvo-z in treating Hereditary angioedema. Data was presented at the European Academy of Allergy and Clinical Immunology Annual Congress 2026.
Hereditary Angioedema (HAE) is a rare genetic disease characterized by unpredictable inflammatory attacks on various organs and tissues of the body, which may be painful and life-threatening. One in 50,000 people may be affected by the disease, and while attacks are managed through lifelong therapies, breakthrough attacks still occur. The inhibition of kallikrein is a validated strategy for preventative treatment of HAE. Lonvo-z (lonvoguran ziclumeran) is an in vivo CRISPR gene editing candidate that inactivates the kallikrein B1 gene to permanently lower kallikrein protein levels. The drug has received Orphan Drug and regenerative medicine advanced therapy (RMAT) designation from the U.S. Food and Drug Administration (FDA), the Innovation Passport by the U.K. Medicines and Healthcare products Regulatory Agency (MHRA), Priority Medicines (PRIME) Designation by the European Medicines Agency, as well as an Orphan Drug Designation (ODD) from the European Commission. It was previously reported that the Phase 3 HAELO trial met its primary endpoint by demonstrating a mean 87% reduction in monthly attacks. 62% of patients were also entirely attack free for the six-month efficacy evaluation period, compared to 11% in the placebo group. The company released data affirming that the trial also met key secondary endpoints. The rate of monthly attacks requiring on-demand treatment saw a 89% reduction in treated patients. The monthly rate of moderate or severe attacks decreased by a mean 91%. Patients also reported a change from baseline on their Angioedema Quality of Life (AE-QoL) score, noting a 17.04-point reduction. A 6-point reduction is considered to be a clinically significant improvement in AE-QoL. The drug was further found to be generally safe and tolerable, with mild to moderate adverse events reported. Additional analysis showed that 20% of patients showed complete disease control after enrollment in the HAELO trial. Plasma kallikrein levels also decreased substantially by the first measurement after treatment and reached a steady state by week 5. Based on the positive Phase 3 results, a rolling biological license application (BLA) submission to the FDA was initiated in April 2026. The company anticipates regulatory approval and a U.S. launch in the first half of 2027.
NTLA closed Friday at $12.11, down 1.94%. In the pre-market, the stock is trading at $12.58, up 3.88%.
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June 12, 2026 17:14 ET Major central bank action was the focus this week in economic news. The European Central Bank became the first major central bank to move in response to the rising inflationary pressures in the backdrop of the conflict in the Middle East. In North America, the U.S. inflation and trade data as well as Canada’s central bank decision gained attention. The Chinese trade data was the main news in Asia.