Will lonvo-z (Intellia) become the first approved in vivo CRISPR therapy, and when?
Opening setting
50%No trades yet. This is the uniform opening setting, not a community forecast.
Probability that the predicted event happens at all: all yes / by-a-date outcomes added together. “Other” is tracked as its own third slice.
Outcomes
Resolution criteria
lonvo-z receives FDA approval; we then check whether it is the first approved in vivo CRISPR drug. Resolution horizon: 2028-12-31. Source: FDA.
Evidence & context
Trials, publications and reports our research found on this prognosis. Each links to the original source.
This is a BioPharma Dive news report on Intellia's late-stage results for lonvo-z in hereditary angioedema. It bears directly on the approval-timing prognosis because it states the company has begun a rolling FDA submission and is targeting a first-half 2027 launch if cleared.
This is a ClinicalTrials.gov registration for the Phase 3 HAELO study of NTLA-2002, an in vivo CRISPR candidate from Intellia for hereditary angioedema. A pivotal Phase 3 trial is directly relevant to the likelihood and timing of eventual FDA approval by the 2028 resolution horizon.
This is a news report stating that Intellia initiated a rolling BLA with the FDA for lonvoguran ziclumeran (lonvo-z) after meeting Phase 3 endpoints. It directly bears on the forecast because FDA filing progress and expedited-review designations are concrete steps toward possible approval by the 2028 resolution date, and the article explicitly frames lonvo-z as a potential first approved in vivo CRISPR therapy.
This is a company-linked SEC 8-K/news page reporting positive Phase 3 HAELO results for lonvo-z and stating that Intellia has initiated a rolling BLA with the FDA. It bears directly on the approval-timing prognosis because it describes late-stage efficacy/safety and the company’s expectation of U.S. approval and launch in the first half of 2027.