Intellia gets FDA nod to resume gene therapy trial after safety pause

Jan 27 (Reuters) - Intellia Therapeutics said on Tuesday that the U.S. drug regulator has lifted a clinical hold on one of ...
Fierce Biotech

After patient death, FDA lifts hold on 1 of 2 late-stage trials testing Intellia's CRISPR therapy

The hold followed Intellia’s voluntary pause in response to a grade 4 liver event—a case of Hy’s Law—in the ATTR-CM trial. Shortly after the regulatory hold was implemented, Intellia disclosed that ...

Intellia Therapeutics Announces FDA Lift of Clinical Hold on MAGNITUDE-2 Phase 3 Clinical Trial in ATTRv-PN

Plan to resume MAGNITUDE-2 patient enrollment and dosing FDA engagement ongoing regarding clinical hold on MAGNITUDE Phase 3 ...

Intellia rises as FDA lifts clinical hold on Regeneron-partnered gene editing drug

Intellia Therapeutics (NTLA) added ~15% in the premarket on Tuesday after the U.S. Food and Drug Administration lifted a ...

Intellia Therapeutics Climbs After FDA Lifts Hold on Phase 3 Trial

The company said Tuesday that the FDA lifted the hold on an Investigational New Drug Application for a phase 3 clinical trial of nexiguran ziclumeran, or nex-z, for patients with a genetic disease ...
BioPharma Dive

FDA lifts hold on an Intellia CRISPR drug trial

Intellia is instituting new safeguards following the death of a study participant that led regulators to pause two trials in ...
Becker's Hospital Review

FDA lifts hold on Intellia’s phase 3 trial for genetic nerve disease

The FDA has lifted a clinical hold on Intellia Therapeutics’ Magnitude-2 phase 3 trial of nexiguran ziclumeran, or nex-z: a CRISPR-based gene therapy for patients with hereditary transthyretin ...
BioSpace

FDA Lifts One of Two Clinical Holds on Intellia’s ATTR Gene Editing Program

After a patient safety signal and then death, the FDA in October 2025 placed holds on two of the company’s CRISPR programs for hereditary transthyretin amyloidosis.
The Pharma Letter

Intellia shares leap as FDA lifts trial hold

Gene editing company Intellia Therapeutics has announced that the US Food and Drug Administration (FDA) has removed the clinical hold on the Investigational New Drug application (IND) for the ...
KRQE Blogs

Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application to Initiate a Pivotal Phase 3 Trial of NTLA-2001 for the Treatment of Transthyretin ...

NTLA-2001 is the first-ever investigational in vivo CRISPR-based gene editing therapy cleared to enter late-stage clinical development CAMBRIDGE, Mass., Oct. 18, 2023 (GLOBE NEWSWIRE) -- Intellia ...

Intellia Therapeutics stock soars after FDA lifts clinical hold on Phase 3 trial

Investing.com -- Intellia Therapeutics (NASDAQ:NTLA) stock soared 20% Tuesday after the U.S. Food and Drug Administration (FDA) lifted a clinical hold on the company’s MAGNITUDE-2 Phase 3 trial for ...