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BiotechnologyGene editingOpen

Will the FDA approve Intellia's lonvo-z, a one-time CRISPR treatment for hereditary angioedema, by March 10, 2027?

Answer in 136 days

How this resolves: Resolves Yes if the FDA approves the Biologics License Application for lonvoguran ziclumeran (lonvo-z) on or before March 10, 2027, as shown on fda.gov or in an Intellia press release.

Closes Mar 9, 2027, 15:00 UTC (12:00 BRT)

Why it matters

Lonvo-z edits a liver gene inside the body with a single infusion. In the Phase 3 HAELO trial it cut monthly swelling attacks by 87% versus placebo. If approved it would be the first in vivo CRISPR therapy cleared anywhere.

Question provenance

How this question entered the record and how it will be resolved.

Resolution criteria
Resolves Yes if the FDA approves the Biologics License Application for lonvoguran ziclumeran (lonvo-z) on or before March 10, 2027, as shown on fda.gov or in an Intellia press release. Resolves No if the FDA issues a Complete Response Letter, extends the review past that date, or takes no action by then.
Expected resolution
Mar 10, 2027

Key evidence

  • Intellia press release (SEC Exhibit 99.1), September 8, 2026: BLA accepted with Priority Review, PDUFA date March 10, 2027, no advisory committee planned
  • Same release: HAELO showed an 87% cut in monthly attacks and no serious adverse events in the lonvo-z arm

Skeptical perspective

The FDA often extends reviews by three months after a major amendment, and a first of its kind gene editing product invites extra scrutiny of long term safety.

What could change the outlook

  • An FDA request for more data that triggers a review extension
  • Long term safety updates from HAELO patients
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How does this question resolve?

Resolves Yes if the FDA approves the Biologics License Application for lonvoguran ziclumeran (lonvo-z) on or before March 10, 2027, as shown on fda.gov or in an Intellia press release. Resolves No if the FDA issues a Complete Response Letter, extends the review past that date, or takes no action by then.

When does this question close?

It closes to new calls on March 9, 2027.