Intellia Therapeutics initiates rolling BLA submission for lonvo-z for HAE

Intellia Therapeutics (NTLA) announced it has initiated a rolling submission of a biologics license application to the U.S. Food and Drug Administration seeking approval of lonvo-z for hereditary angioedema. Designed as a one-time treatment that is administered in an outpatient setting, lonvo-z is an in vivo CRISPR gene editing candidate that is intended to inactivate the kallikrein B1 gene to permanently lower kallikrein and bradykinin levels. “If approved, lonvo-z will become the world’s first in vivo CRISPR-based gene editing therapy,” said John Leonard, M.D., Intellia President and Chief Executive Officer. “The promising results from HAELO reinforce our conviction that lonvo-z could revolutionize how HAE is treated for many patients, with the potential to free most of them from both attacks and the need for ongoing therapy with just one dose. We look forward to our continued engagement with the FDA as we seek to ease many of the burdens for people living with HAE.” Intellia anticipates completing its BLA submission in the second half of 2026. If the filing is accepted by the FDA, the agency is expected to determine if it will grant a priority review and provide a target action date to complete its evaluation. If approved, Intellia plans to launch lonvo-z commercially in the first half of 2027.