- Trial Phase
- Phase 3
- Time to Market
- If MAGNITUDE-2 Phase 3 data are positive, a regulatory filing (BLA) would likely follow in 2027, with potential approval in 2028 at the earliest — assuming no further clinical holds or safety issues.
- Why 7/10
- The next hard catalyst is the MAGNITUDE-2 Phase 3 topline readout for nex-z in hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN), expected in H2 2026 (within ~4 months). This is a pivotal readout for a major pipeline asset, but Intellia also has the lonvo-z BLA as a separate value driver, so nex-z is not the company's only binary — impactScore of 7 reflects a major but not make-or-break catalyst.
Watch for MAGNITUDE-2 Phase 3 topline data for nex-z in ATTRv-PN, expected in H2 2026 (likely within the next 4 months). Positive data would validate Intellia's in vivo CRISPR platform beyond lonvo-z; negative data or renewed safety concerns would be a major setback. The stock also has a lonvo-z BLA catalyst (approval decision H1 2027) that partially de-risks the single-asset binary.
Price Chart
Executive Summary
nex-z (nexiguran ziclumeran) is Intellia Therapeutics' CRISPR-based in vivo gene editing therapy for transthyretin amyloidosis (ATTR), targeting both cardiomyopathy (ATTR-CM) and polyneuropathy (ATTRv-PN) forms. Both Phase 3 MAGNITUDE trials were placed on clinical hold in October 2025 due to liver safety concerns but have since been lifted (MAGNITUDE-2 in Jan 2026, MAGNITUDE in Mar 2026). The next major catalyst is the MAGNITUDE-2 topline readout expected in H2 2026. Intellia trades at ~$12.78 (Nasdaq: NTLA) with a ~$1.5B market cap, $628M cash runway into 2028, and a separate lonvo-z BLA for hereditary angioedema that provides a second value driver. The stock has a mixed analyst consensus (13 Buy/Strong Buy, 8 Hold, 3 Sell/Strong Sell) with a mean price target of ~$23.94, implying ~87% upside from current levels.
How It Works
nex-z is a CRISPR-based gene therapy injected intravenously that permanently edits a specific gene (TTR) in liver cells. It uses CRISPR/Cas9 to knock out the production of transthyretin protein, which misfolds and builds up as toxic amyloid deposits in the heart and nerves in ATTR amyloidosis. It is designed as a one-time treatment rather than requiring lifelong daily medication.
Trial Status
Two Phase 3 trials: MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN). Both were placed on clinical hold by the FDA on October 29, 2025 due to liver transaminase elevations. The MAGNITUDE-2 hold was lifted on January 27, 2026; the MAGNITUDE hold was lifted on March 2, 2026 after enhanced safety monitoring was implemented. Enrollment has resumed in both trials. MAGNITUDE-2 completion is expected in H2 2026.
The Two-Sided Case
Upcoming Catalysts
- MAGNITUDE-2 Phase 3 topline data readout for nex-z in ATTRv-PN — expected H2 2026 (within ~4 months)
- MAGNITUDE Phase 3 data readout for nex-z in ATTR-CM — timeline TBD, likely follows MAGNITUDE-2
- Potential BLA submission for nex-z if Phase 3 data are supportive — likely 2027
Source Filing
The SecBot filing or press-release report that triggered this drug report:
Intellia Therapeutics, Inc. 8-K NTLA ·Originating report