Intellia Therapeutics, Inc. 8K

Intellia Therapeutics received FDA Priority Review for its BLA for lonvo-z for hereditary angioedema, with a PDUFA date of March 10, 2027, supported by positive Phase 3 data.

Intellia Therapeutics, Inc. announced that the U.S. Food and Drug Administration has accepted its Biologics License Application for lonvoguran ziclumeran (lonvo-z), an in vivo CRISPR-based gene-editing therapy for hereditary angioedema, and granted it Priority Review with a PDUFA target action date of March 10, 2027, with no advisory committee currently planned; the submission is supported by positive Phase 3 HAELO trial data demonstrating substantial reductions in attack rates and favorable safety, positioning lonvo-z as a potential first-ever in vivo CRISPR therapy and one-time treatment option for HAE if approved.

Filing Facts

CIK

1652130

Ticker

NTLA

Form

8K

Source Type

fda

Accession

0001193125-26-385194

Alert Tier

6