The U.S. Food and Drug Administration has officially lifted the clinical hold on Intellia Therapeutics’ Phase 3 MAGNITUDE-2 trial evaluating nexiguran ziclumeran (nex-z) for hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). This decision follows the company’s submission of additional safety data and updated monitoring protocols, allowing Intellia to resume dosing patients enrolled across 25 trial sites in North America and Europe. The trial aims to enroll approximately 150 participants over the next 12 months, targeting a primary endpoint of neuropathy impairment score reduction at 18 months.

Intellia’s shares surged 6.3% in the latest trading session, with daily volume surpassing the three-month average by 45%. Market participants cited the FDA’s decision as a key catalyst, driving optimism around the company’s lead in in vivo CRISPR-based therapies. Analysts at Biotech Insights have raised their probability-of-success estimate for nex-z from 55% to 70%, while maintaining a market-outlook rating of Overweight based on the drug’s first-mover advantage in the ATTRv-PN space.

With the clinical hold removed, Intellia plans to restart dosing by mid-March, pending site activation and investigator training. The company has secured an additional $75 million in cash reserves through a private placement closed last quarter, ensuring sufficient runway to complete interim data readouts expected in Q4 2026. Regulatory filings to expand the MAGNITUDE program into Asia are also underway, with preliminary discussions initiated with Japan’s Pharmaceuticals and Medical Devices Agency for potential trial site inclusion.