NTLA Intellia Therapeutics, Inc.
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Executive Summary
Intellia Therapeutics announced that the FDA has lifted the clinical hold on its Phase 3 MAGNITUDE trial for nexiguran ziclumeran (nex-z) in patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM), following implementation of enhanced safety monitoring and patient exclusion criteria. The company is now working to resume enrollment in both MAGNITUDE and MAGNITUDE-2 trials. This clears a key regulatory hurdle for a potential one-time CRISPR-based treatment for ATTR-CM.
Actionable Insight
Traders should monitor resumption of enrollment in MAGNITUDE and MAGNITUDE-2 trials and upcoming interim data readouts, which could serve as next catalysts. The resolution of the FDA hold removes near-term regulatory risk and renews confidence in Intellia’s CRISPR platform’s clinical viability.
Key Facts
- FDA has removed the clinical hold on the MAGNITUDE Phase 3 trial for nex-z in ATTR-CM.
- Clinical hold was initiated in October 2025 due to Grade 4 liver transaminases and elevated bilirubin in one patient.
- Mitigation measures include enhanced liver monitoring, steroid treatment guidance, and new exclusion criteria for liver abnormalities and low ejection fraction (<25%).
- MAGNITUDE trial involves ~1,200 patients; MAGNITUDE-2 (for ATTRv-PN) involves ~60 patients.
- Nex-z is a CRISPR-based therapy designed to inactivate the TTR gene, with potential as a one-time treatment.
- Nex-z has RMAT and Orphan Drug designations from the FDA.
Financial Impact
Removal of clinical hold significantly de-risks the development path for nex-z, a pivotal asset. Successful completion could position nex-z as a first-in-class one-time therapy with multi-billion dollar peak sales potential in ATTR-CM, a life-threatening rare disease with limited treatment options.
Risk Factors
- Potential for additional safety issues to emerge despite new monitoring protocols.
- Enrollment delays due to revised exclusion criteria or international regulatory hurdles.
- Clinical trial results may not meet efficacy endpoints despite safety clearance.
Market Snapshot
Documents Analyzed
This report is based on 1 press release from GlobeNewswire.
| Document | Accession Number |
|---|---|
| PRESS-RELEASE Data (Synthetic) | press-3247267 |
Track record builds as more directional reports settle.
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Jun 13, 2026
1d ago
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Press Release
| — | awaiting T+5 | — | — |
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Jun 1, 2026
13d ago
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Press Release
| $13.73 $13.54 | ▼ −1.38% | ▲ +1.37% | $12.11 (−11.80%) |
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May 11, 2026
4w ago
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8-K
| $14.42 $12.69 | ▼ −12.00% | ▼ −11.91% | $12.11 (−16.02%) |
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Apr 27, 2026
6w ago
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Press Release
| $13.20 $13.87 | ▼ −5.08% | ▼ −3.38% | $12.11 (+8.26%) |
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Apr 27, 2026
6w ago
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8-K
| $13.04 $13.87 | ▲ +6.37% | ▲ +5.96% | $12.11 (−7.13%) |
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Apr 3, 2026
10w ago
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Press Release
| $13.30 $14.26 | ▲ +7.22% | ▲ +3.08% | $12.11 (−8.95%) |
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Mar 6, 2026
14w ago
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Press Release
| $13.89 $13.38 | ▼ −3.67% | ▼ −2.32% | $12.11 (−12.81%) |
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Mar 2, 2026
14w ago
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Press Release
| $15.44 $13.89 | ▼ −10.04% | ▼ −8.83% | $12.11 (−21.57%) |
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Mar 2, 2026
15w ago
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Insider Cluster
| $15.44 $13.89 | ▼ −10.04% | ▼ −8.83% | $12.11 (−21.57%) |
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Feb 28, 2026
15w ago
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Institutional Cluster
| $15.44 $13.89 | ▼ −10.04% | ▼ −8.83% | $12.11 (−21.57%) |
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