FDA Lifts Hold on Intellia’s Phase 3 Gene-Editing Trial for Deadly Heart Disease
Intellia Therapeutics gets FDA approval to resume its Phase 3 trial for nexiguran ziclumeran, a gene-editing treatment for ATTR-CM heart disease, boosting shares by 6%.
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Intellia Shares Jump After FDA Lifts Clinical Hold on Gene Therapy Trial
Intellia Therapeutics’ stock rises as the FDA clears a Phase 3 trial for its gene therapy, nexiguran ziclumeran, for a rare genetic disease.
Intellia Therapeutics Shares Plunge 29% After FDA Pauses Key Gene Therapy Trials
Intellia Therapeutics (NTLA) shares fell 29% premarket after the FDA paused two late-stage gene-editing trials following a patient death linked to liver complications.
FDA’s New Fast-Track Plan for Custom Gene Editing Could Transform Rare Disease Treatments
The FDA is unveiling a faster approval pathway for custom gene-editing therapies, aiming to spark major investment and accelerate cures for rare diseases through Crispr-based innovations.
Intellia Therapeutics Stock Plunges on FDA Clinical Hold
Intellia Therapeutics (NTLA) shares drop 15% after FDA halts late-stage gene therapy trials following serious liver safety concerns in patient.
Intellia Pauses Gene Therapy Trials After Patient Develops Severe Liver Injury
Intellia Therapeutics halts MAGNITUDE trials of nex-z gene therapy after patient hospitalization with Grade 4 liver toxicity. Over 650 patients enrolled in ATTR amyloidosis studies.