Intellia Therapeutics, Inc.

Intellia Therapeutics announced the FDA has accepted its Biologics License Application (BLA) for lonvoguran ziclumeran (lonvo-z) for the treatment of hereditary angioedema (HAE), granting it Priority Review with a target action date of March 10, 2027. The FDA has indicated it does not plan to hold an advisory committee meeting for this application. If approved, lonvo-z would represent a significant advancement as the world's first in vivo CRISPR-based therapy and a potential one-time treatment for HAE. Phase 3 trial data demonstrated substantial reductions in HAE attacks and a high percentage of patients remaining attack-free.

Intellia Therapeutics, Inc. announced that it awarded inducement grants totaling 38,200 time-based Restricted Stock Units (RSUs) to eight new employees on August 1, 2026. These grants, made under the company's 2024 Inducement Plan, are subject to annual vesting over three years, contingent on the employee's continued service. The awards were approved by the compensation committee as a material inducement for employment, in compliance with Nasdaq Listing Rule 5635(c)(4).

Intellia Therapeutics reported positive topline data from its Phase 3 HAELO clinical trial for lonvo-z in hereditary angioedema (HAE) in April 2026, with a planned commercial launch in the first half of 2027, if approved. For the second quarter of 2026, the company's net loss increased to $(106.6) million, and collaboration revenue decreased to $7.7 million. The company strengthened its liquidity with $229.7 million in net cash from financing activities in the first half of 2026, including a $194.6 million follow-on public offering, and expects current cash to fund operations for at least 12 months.

Intellia Therapeutics announced its second quarter 2026 financial results and business updates, highlighted by positive Phase 3 HAELO clinical data for lonvo-z in hereditary angioedema (HAE), which showed an 87% reduction in attacks versus placebo. The company anticipates FDA BLA acceptance for lonvo-z in the second half of 2026 and a U.S. launch in the first half of 2027. Enrollment for nex-z Phase 3 clinical trials has been reinitiated, with MAGNITUDE-2 enrollment expected to be completed in the second half of 2026. Intellia reported a net loss of $106.6 million for Q2 2026 and ended the quarter with approximately $628 million in cash, expected to fund operations at least into 2028.

Intellia Therapeutics reported positive Phase 3 HAELO clinical data for lonvo-z in hereditary angioedema (HAE), showing an 87% reduction in attacks versus placebo. The company anticipates FDA acceptance of its Biologics License Application (BLA) for lonvo-z in H2 2026, with a U.S. launch planned for H1 2027. Additionally, enrollment for nex-z Phase 3 trials was reinitiated, and the company ended Q2 2026 with $628.4 million in cash, funding operations into 2028. The net loss for Q2 2026 was $106.6 million.

Intellia Therapeutics, Inc. announced it will host a conference call on August 6, 2026, at 8 a.m. ET. The purpose of the call is to discuss the company's second quarter 2026 financial results and provide business updates. Investors can access the call via webcast or teleconference, with replay available for approximately 90 days.

Intellia Therapeutics announced additional positive Phase 3 results for its hereditary angioedema (HAE) treatment, lonvoguran ziclumeran (lonvo-z). The HAELO trial demonstrated a significant 87% reduction in mean monthly attacks and 62% of patients remaining attack-free for six months. Key secondary endpoints also showed substantial improvements, including an 89% reduction in attacks requiring on-demand treatment and a 91% reduction in moderate/severe attacks. The drug exhibited a favorable safety profile with no serious adverse events reported. Intellia has initiated a rolling BLA submission and anticipates a U.S. launch in the first half of 2027.

Intellia Therapeutics presented additional positive Phase 3 HAELO clinical trial results for lonvo-z (formerly NTLA-2002) for hereditary angioedema (HAE) at the EAACI Annual Congress 2026, with simultaneous publication in the New England Journal of Medicine. The trial met its primary endpoint with an 87% reduction in mean monthly HAE attacks and showed 62% of patients were attack-free. Key secondary endpoints also demonstrated significant reductions in attacks requiring on-demand treatment (89%) and moderate/severe attacks (91%), alongside improved quality of life. The company initiated a rolling BLA submission in April and anticipates regulatory approval and a U.S. launch in H1 2027.

Intellia Therapeutics announced that data from its global Phase 3 HAELO clinical trial of lonvo-z for hereditary angioedema (HAE) will be presented in a late-breaking oral presentation at the European Academy of Allergy & Clinical Immunology (EAACI) Annual Congress 2026. Lonvo-z, a CRISPR-based gene editing therapy, aims to be a one-time treatment for HAE by permanently lowering kallikrein. The company will also present a poster on the burdens faced by HAE patients outside the U.S.

Intellia Therapeutics reported a net loss of $(96.2) million, or $(0.81) per share, for Q1 2026, an improvement from $(114.3) million, or $(1.10) per share, in Q1 2025. Collaboration revenue decreased slightly to $15.0 million. The company announced positive topline data from the global Phase 3 HAELO clinical trial of lonvo-z in hereditary angioedema (HAE) in April 2026, with preparations underway for a commercial launch in the first half of 2027. Additionally, Intellia entered into a new 12-year lease agreement for office and laboratory space in Cambridge, MA, and is involved in several legal proceedings.