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Stock Markets January 27, 2026

Intellia Shares Jump After FDA Removes Hold on MAGNITUDE-2 Phase 3 Trial

Regulator permits resumption of enrollment in ATTRv-PN study of nexiguran ziclumeran with expanded patient target

By Priya Menon NTLA
Intellia Shares Jump After FDA Removes Hold on MAGNITUDE-2 Phase 3 Trial
NTLA

Intellia Therapeutics saw its stock rise sharply after the FDA lifted a clinical hold on the company’s MAGNITUDE-2 Phase 3 study of nexiguran ziclumeran (nex-z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). The removal of the hold allows patient enrollment to restart and prompts a modest increase in the trial's target size.

Key Points

  • FDA lifted the clinical hold on Intellia’s MAGNITUDE-2 Phase 3 trial for ATTRv-PN, enabling resumption of patient enrollment.
  • Intellia plans to increase MAGNITUDE-2 target enrollment from about 50 to about 60 patients.
  • MAGNITUDE-2 is a randomized, double-blind, placebo-controlled study assessing a single 55 mg infusion of nexiguran ziclumeran versus placebo, with primary endpoints of modified neuropathy impairment score and serum TTR levels.

Intellia Therapeutics (NASDAQ:NTLA) experienced a notable market reaction Tuesday after the U.S. Food and Drug Administration lifted a clinical hold on its MAGNITUDE-2 Phase 3 trial evaluating nexiguran ziclumeran (nex-z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). Shares climbed roughly 20% on the news as the company prepared to restart patient enrollment.

The FDA removed the clinical hold placed on the Investigational New Drug application specifically for the MAGNITUDE-2 study, enabling Intellia to proceed with enrolling patients. Intellia said it will raise the trial’s planned enrollment from approximately 50 patients to approximately 60 patients.

Intellia’s president and chief executive officer, John Leonard, said the team is focused on resuming enrollment quickly as it works to advance what the company describes as a potential one-time treatment option for people living with ATTRv-PN.

The regulatory action reverses a pause that regulators placed on both the MAGNITUDE and MAGNITUDE-2 trials on October 29, 2025. That pause followed an event in the MAGNITUDE trial in which a patient experienced Grade 4 elevations in liver transaminases and an increase in total bilirubin, meeting the protocol’s predefined criteria for a pause.

While MAGNITUDE-2 is now cleared to continue, it will proceed under enhanced safety monitoring focused on liver laboratory tests. Intellia also noted that discussions with the FDA remain ongoing with respect to the clinical hold that is still in place on the MAGNITUDE trial for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM).

MAGNITUDE-2 is structured as a randomized, double-blind, placebo-controlled study designed to evaluate both the efficacy and safety of a single 55 mg infusion of nex-z compared with placebo. The trial’s primary endpoints include changes in a modified neuropathy impairment score and in serum transthyretin (TTR) levels.

The FDA decision to lift the hold on MAGNITUDE-2 allows the company to move forward with the ATTRv-PN program while regulatory dialogue continues around the cardiomyopathy-focused MAGNITUDE trial.

Risks

  • Enhanced safety monitoring for liver laboratory values will be required for MAGNITUDE-2, reflecting ongoing safety concerns that could affect trial conduct and timelines - impacts biotech and healthcare sectors.
  • The MAGNITUDE trial for ATTR-CM remains under clinical hold while Intellia continues regulatory discussions with the FDA, creating uncertainty for the cardiomyopathy program and investor expectations in the biotech sector.
  • The earlier patient event that prompted the October 29, 2025 clinical holds involved Grade 4 liver transaminase elevations and increased total bilirubin, underscoring safety risks that could influence trial outcomes and regulatory decisions - relevant to clinical development and investor risk assessment.

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