Intellia Therapeutics has begun a rolling FDA submission for its in vivo CRISPR therapy lonvo-z, following Phase III results showing an 87% reduction in hereditary angioedema attacks versus placebo.
Intellia also separately announced positive topline data today from the Phase 3 HAELO clinical trial of lonvo-z in HAE. The trial met its primary and all key secondary endpoints, demonstrating that a ...
Intellia Therapeutics said its Crispr-based treatment for hereditary angioedema met its goals in a Phase 3 trial, marking a milestone for gene editing.
A phase 3 trial of Intellia Therapeutics’ in vivo gene-editing therapy lonvoguran ziclumeran (lonvo-z) has hit its primary endpoint, leading the biotech to start a rolling submission for FDA approval.
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Intellia seeks FDA nod after phase 3 CRISPR success
Intellia Therapeutics has begun a rolling FDA submission for lonvoguran ziclumeran (lonvo-z) after its phase 3 trial showed an 87% reduction in hereditary angioedema attacks versus placebo. The ...
Phase 3 HAELO trial of lonvoguran ziclumeran (lonvo-z) met primary and all key secondary endpoints; favorable safety and tolerability data observed Single dose of lonvo-z freed most patients from both ...
Presented positive Phase 3 HAELO topline clinical data for lonvo-z in HAE; initiated rolling BLA submission; anticipate U.S. launch in first half of 2027Recently resumed patient screening in MAGNITUDE ...
FILE PHOTO: Signage is seen outside of the Food and Drug Administration (FDA) headquarters in White Oak, Maryland, U.S., August 29, 2020. REUTERS/Andrew Kelly/File Photo (Reuters) -Intellia ...
Comprehending the spate of recent rejections in the cell and gene therapy space may require looking no further than early-stage clinical trials of candidates from REGENXBIO, Excision BioTherapeutics ...
In late April 2026, Intellia Therapeutics completed a US$180.00 million follow-on offering of 16,744,187 common shares at US$10.75 each, shortly after reporting that its in vivo CRISPR therapy lonvo-z ...
A CRISPR Therapy Just Cured A Disease From Inside The Body For The First Time. The Gene-Editing Era Officially Started Monday.
Veradermics' hair loss pill late-stage trial success, FDA fast-tracks reviews for psychedelics, and more biotech news ...
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