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FDA Lifts Hold on Intellia’s MAGNITUDE-2 Trial

Story Highlights
  • Intellia won FDA clearance to restart its MAGNITUDE-2 Phase 3 ATTRv-PN trial after safety-driven changes.
  • The ATTR-CM MAGNITUDE trial remains on hold, keeping regulatory and development risks elevated for nex-z.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
FDA Lifts Hold on Intellia’s MAGNITUDE-2 Trial

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Intellia Therapeutics ( (NTLA) ) just unveiled an update.

On January 27, 2026, Intellia Therapeutics announced that the U.S. Food and Drug Administration lifted the clinical hold on its investigational new drug application for the MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), a hold that had been imposed on October 29, 2025 after a MAGNITUDE trial patient experienced severe liver toxicity and subsequently died. Following alignment with the FDA on protocol modifications and enhanced liver safety monitoring, Intellia plans to resume enrollment and dosing in MAGNITUDE-2, expand target enrollment from about 50 to 60 patients, and continue evaluating the efficacy and safety of a single 55 mg infusion of nex-z versus placebo; however, the separate MAGNITUDE Phase 3 trial in ATTR-CM remains on clinical hold as discussions with the agency continue, leaving a key part of the nex-z program and Intellia’s broader ATTR strategy still subject to regulatory uncertainty for patients, investigators and investors.

The most recent analyst rating on (NTLA) stock is a Hold with a $14.50 price target. To see the full list of analyst forecasts on Intellia Therapeutics stock, see the NTLA Stock Forecast page.

Spark’s Take on NTLA Stock

According to Spark, TipRanks’ AI Analyst, NTLA is a Neutral.

Overall score reflects very weak profitability and persistent cash burn as the primary constraint, partially offset by a relatively solid balance sheet/cash runway and positive price momentum. The outlook is further capped by the nex-z FDA clinical hold and associated safety concerns, while valuation metrics provide limited support due to negative earnings and no dividend yield.

To see Spark’s full report on NTLA stock, click here.

More about Intellia Therapeutics

Intellia Therapeutics, Inc. (NASDAQ:NTLA) is a clinical-stage gene editing company based in Cambridge, Massachusetts, focused on developing CRISPR-based therapies to address significant unmet medical needs, including transthyretin amyloidosis. The company is advancing nexiguran ziclumeran (nex-z), a potential one-time gene-editing treatment for transthyretin amyloidosis with cardiomyopathy (ATTR-CM) and hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN), under a multi-target collaboration with Regeneron Pharmaceuticals.

Average Trading Volume: 6,355,313

Technical Sentiment Signal: Hold

Current Market Cap: $1.62B

Find detailed analytics on NTLA stock on TipRanks’ Stock Analysis page.

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