Intellia Therapeutics Receives Partial FDA Clearance for Key Trial

Intellia Therapeutics has secured regulatory approval to resume a significant portion of its late-stage clinical program. The U.S. Food and Drug Administration (FDA) has lifted a clinical hold on the company's MAGNITUDE-2 Phase 3 study, allowing patient recruitment to restart under revised safety protocols. However, a separate and larger Phase 3 trial, named MAGNITUDE, remains suspended, presenting a continued hurdle for the biotech firm.

Following an agreement on enhanced safety monitoring, the FDA has removed the clinical hold on the MAGNITUDE-2 study. The updated protocols mandate more frequent liver function testing for participants. Additionally, Intellia has increased the target enrollment for this trial from approximately 50 to 60 patients.

The study evaluates the efficacy of nex-z, an in vivo CRISPR/Cas9 therapy designed to reduce the production of the transthyretin (TTR) protein following a single treatment. It focuses on patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).

Key Trial Status Updates:
* Resumed: MAGNITUDE-2 (Phase 3, ATTRv-PN) – Patient recruitment has recommenced
* Remains on Hold: MAGNITUDE (Phase 3, ATTR-CM) – FDA clinical hold continues
* Enhanced Safety: Stricter liver function monitoring implemented
* Increased Scale: MAGNITUDE-2 enrollment target raised from ~50 to 60 patients

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Cardiomyopathy Study Pause Persists

The restart of the polyneuropathy study represents progress but is limited in scope. The FDA has not yet cleared the clinical hold on the separate MAGNITUDE trial for transthyretin amyloidosis with cardiomyopathy (ATTR-CM), which investigates the same drug candidate.

Both studies were initially paused in October 2025. The suspension was triggered by a serious adverse event involving liver toxicity in the cardiomyopathy program, which subsequently led to a patient's death. Regulatory filings indicate the FDA has accepted the proposed risk mitigation measures for the ATTRv-PN patient group. Discussions regarding the path forward for the larger ATTR-CM indication are ongoing between Intellia and regulators.

Investor Implications of a Split Decision

This partial clearance creates a mixed outlook for shareholders. While the resumption of MAGNITUDE-2 is a positive development, the ATTR-CM program is widely considered to hold substantially greater commercial potential. Consequently, the continued FDA hold on the MAGNITUDE trial remains a significant overhang on the company's prospects.

Investor attention now turns to Intellia's upcoming financial results. The company is scheduled to report fourth-quarter and full-year 2025 figures in late February. These updates are expected to provide further clarity on two critical fronts: the timeline for a potential resolution of the remaining clinical hold and the pace of patient recruitment in the recently restarted MAGNITUDE-2 study.