Intellia Therapeutics Stock Earnings Reports

Intellia announced a clinical hold (verbal notification from FDA) on its nex-z Phase III programs MAGNITUDE (ATTR cardiomyopathy) and MAGNITUDE-2 (ATTR polyneuropathy) after a patient dosed on Sept 30 was hospitalized with severe liver test abnormalities and subsequently died; the company paused dosing and screening across both trials as a precaution and is awaiting the FDA's formal clinical-hold letter. Management said they have enrolled >650 patients in MAGNITUDE and 47 in MAGNITUDE-2, that Grade 4 liver transaminase elevations have occurred in <1% of MAGNITUDE patients (with no Grade 4 cases reported in MAGNITUDE-2), and that most prior events are resolving. Intellia is conducting a comprehensive internal review, increasing early post-dose liver monitoring, working with independent DSMCs and regulators, and evaluating potential risk‑mitigation and enrollment-criteria changes; milestone timing for nex-z is no longer maintained. Separately, lonvo-z (HAE) Phase III (HAELO) completed enrollment in <9 months and remains on track for topline data mid-2026, a potential BLA in H2 2026 and a planned U.S. launch in H1 2027. Financially, Intellia reported cash, cash equivalents and marketable securities of $669.9M as of Sept 30, 2025 (down from $861.7M at year-end 2024), raised ~ $115M via ATM in Q3, and expects its cash runway into mid-2027 to support operations through the anticipated lonvo-z launch; Q3 net loss was $101.3M (vs. $135.7M prior year), R&D and G&A expenses declined year-over-year, and management said they expect at least a 10% YOY decline in GAAP operating expenses. Management emphasized patient safety as first priority and that further updates will follow once the FDA letter and additional analyses are complete.