Intellia Therapeutics, Inc. 8-K

What Happened
Intellia Therapeutics (NTLA) filed an 8‑K on January 9, 2026 updating its corporate presentation and reporting that the FDA has placed a clinical hold on the Investigational New Drug applications for its Phase 3 MAGNITUDE and MAGNITUDE‑2 trials of nexiguran ziclumeran (“nex‑z”). The clinical hold follows a previously reported Grade 4 liver transaminase event and increased total bilirubin in a patient dosed in MAGNITUDE; that patient died on November 5, 2025 (principal investigator reported cause: septic shock secondary to a perforated duodenal ulcer). The patient’s course included acute liver injury treated with corticosteroids and an autopsy that supported the clinical diagnoses.

Key Details

• Filing date: Current Report on Form 8‑K furnished January 9, 2026; corporate presentation included as Exhibit 99.1.
• Trial enrollment: MAGNITUDE (ATTR‑CM) has enrolled more than 650 patients; MAGNITUDE‑2 (ATTRv‑PN) has enrolled 47 patients.
• Safety events: Grade 4 liver transaminase elevations reported in <1% of MAGNITUDE patients; none reported in MAGNITUDE‑2. Onset of Grade 4 events occurred 3–5 weeks after dosing and, except for the fatal case, resolved within several weeks without reported clinical sequelae.
• Next steps: Intellia says it will provide an update after finalizing a plan with regulators to resolve the clinical hold.

Why It Matters
The FDA clinical hold affects late‑stage development of nex‑z, Intellia’s candidate for ATTR amyloidosis, and could delay or alter trial timelines and regulatory plans. The filing confirms the serious liver events are rare but have occurred in the Phase 3 program and that the company is actively engaging regulators on next steps — information material to investors monitoring development progress, regulatory risk, and the timeline for potential approval.