Intellia FDA lifts clinical hold on nex-z MAGNITUDE Phase 3 trial for ATTR-CM

Intellia Therapeutics, Inc.

FDA removed clinical hold on MAGNITUDE Phase 3 trial of nex-z for ATTR-CM after Grade 4 liver event on Oct 29, 2025.
Mitigation measures include enhanced liver monitoring, short-term steroid guidance, and exclusion of certain liver abnormalities.
For MAGNITUDE, added exclusion criteria for recent cardiovascular instability and ejection fraction <25%.
MAGNITUDE-2 clinical hold for ATTRv-PN was resolved in January 2026; enrollment activities resuming.
Amended ATM offering to up to $1.035B aggregate (from $750M); $635M sold, up to $400M additional shares remain.

item 1.01 item 7.01 item 8.01 item 9.01

Key facts

Extracted from this filing and checked against the source text.

Material Agreements SEC 8-K Item 1.01/1.02 confidence 0.9

Intellia Therapeutics, Inc. amended Sales Agreement with Jefferies LLC valued at $1,035,316,650 (effective 2026-03-02).

Action: amendment
Agreement: atm program
Counterparty: Jefferies LLC
Value: $1,035,316,650
Effective: 2026-03-02

Exact text from the filing

On March 2, 2026, the Company entered into an amendment to the Sales Agreement to increase the size of the at-the-market offering program from $750,000,000 to $1,035,316,650.

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Intellia Therapeutics, Inc. filing history →

Source: SEC EDGAR

accession 0001193125-26-084309

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