Intellia Therapeutics Inc. (NASDAQ:NTLA) shares are up on Monday following the FDA’s decision to lift the clinical hold on its MAGNITUDE Phase 3 clinical trial.
The FDA imposed clinical holds on the INDs for MAGNITUDE and MAGNITUDE-2 in October 2025, following the observation of Grade 4 liver transaminases and increased total bilirubin in a patient who was dosed with nex-z in MAGNITUDE that met the trial’s protocol-defined pausing criteria.
The positive news comes as broader markets experienced declines, with the Nasdaq falling 1.35% on the previous trading day.
FDA Green Light
The U.S. Food and Drug Administration (FDA) has removed the clinical hold on Intellia’s Investigational New Drug application for the MAGNITUDE trial, which evaluates the efficacy and safety of nexiguran ziclumeran (nex-z) for patients with transthyretin amyloidosis with cardiomyopathy (ATTR-CM).
The company aims to complete enrollment in both the MAGNITUDE and MAGNITUDE-2 trials, which are critical for advancing its treatment options.
The company has aligned with the FDA on mitigation measures for MAGNITUDE and MAGNITUDE-2 that include enhanced monitoring of liver laboratory tests, guidance for short-term steroid treatment if elevated liver transaminases are observed in the initial period following dosing, and the exclusion of patients with certain liver abnormalities.
The FDA removed the clinical hold MAGNITUDE-2 trial in January.
For MAGNITUDE, additional exclusion criteria are being incorporated for patients with a recent history of cardiovascular instability and those with an ejection fraction <25% at the time of screening.
The MAGNITUDE trial is evaluating the efficacy and safety of nex-z in approximately 1,200 patients with ATTR-CM.
The MAGNITUDE-2 study is evaluating the efficacy and safety of nex-z in approximately 60 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN).
Technical Analysis
The stock is currently trading 8.85% above its previous close, reflecting a strong reaction to the positive news. Shares have increased 20% over the past 12 months and are positioned closer to their 52-week highs than lows, indicating a favorable long-term trend.
The RSI is at 50.00, which is considered neutral territory, suggesting neither overbought nor oversold conditions. Meanwhile, MACD is at 0.10, below its signal line at 0.15, indicating some bearish pressure on the stock.
The combination of neutral RSI and bearish MACD suggests mixed momentum, indicating that traders should watch for potential shifts in market sentiment.
- Key Resistance: $16.50
- Key Support: $14.00
Analyst Consensus & Recent Actions: The stock carries a Buy Rating with an average price target of $19.73. Recent analyst moves include:
- Chardan Capital: Buy (Maintains Target to $26.00) (Feb. 27)
- HC Wainwright & Co.: Buy (Raises Target to $25.00) (Jan. 28)
NTLA Price Action: Intellia Therapeutics shares were up 2.69 at $14.15 on Monday, according to Benzinga Pro data.
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