Intellia reports Q3 2026 results, cites progress toward lonvo-z launch and nex-z Phase 3 enrollment
Intellia said it remains on track for a March 10, 2027 PDUFA date for lonvo-z and completed enrollment in its MAGNITUDE-2 Phase 3 trial in ATTRv-PN.
Intellia Therapeutics reported financial results and business updates for the third quarter ended September 30, 2026, on November 5, 2026.
For lonvoguran ziclumeran (lonvo-z) in hereditary angioedema, the company said it is in September, the U.S. Food and Drug Administration accepted the Biologics License Application for lonvo-z and granted the BLA Priority Review with a Prescription Drug User Fee Act target action date of March 10, 20271. The FDA also advised that it is not currently planning to hold an advisory committee to discuss the application1. Intellia said it significantly advanced its launch readiness in recent months, completing the deployment of its field organization and deepening its engagement with HAE treatment centers and payers in preparation for a planned commercial launch in the first quarter of 20271.
On nexiguran ziclumeran (nex-z) in ATTR amyloidosis, developed with Regeneron Pharmaceuticals, Inc., Intellia leads the development and commercialization of nex-z in collaboration with Regeneron1. The company completed enrollment in its MAGNITUDE-2 Phase 3 clinical trial in hereditary ATTR amyloidosis with polyneuropathy during the third quarter, exceeding its targeted randomization of 60 patients1, and said it made significant progress advancing enrollment in its MAGNITUDE Phase 3 clinical trial in ATTR amyloidosis with cardiomyopathy1.
In September, Intellia entered into a non-dilutive senior secured term loan facility with OrbiMed, a leading global healthcare investment firm, for up to $400 million1.
On finances, cash, cash equivalents and marketable securities were $614.8 million as of September 30, 2026, compared to $605.1 million as of December 31, 20251. The company said its existing cash resources are expected to fund its operations at least into 2028 and well beyond lonvo-z's anticipated U.S. approval and commercial launch in HAE in the first quarter of 2027, a guidance that excludes all potential commercial revenues from lonvo-z and potential future funding from the term loan facility1. Net loss for the quarter was $127.5 million, compared to $101.3 million for the third quarter of 20251.
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