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NTLA Stock Up More Than 6% as FDA Lifts ATTRv-PN Study Clinical Hold
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Key Takeaways
FDA lifts clinical hold on NTLA's MAGNITUDE-2 phase III IND for nex-z in ATTRv-PN, enabling study resumption.
NTLA aligned with the FDA on study changes and liver monitoring. It plans to resume enrollment and dosing.
Nex-z is Intellia's lead program, in partnership with Regeneron, which shares 25% of R&D costs and profits.
Intellia Therapeutics (NTLA - Free Report) announced that the FDA lifted the clinical hold on the investigational new drug application (IND) for the phase III study, MAGNITUDE-2, evaluating nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).
NTLA shares gained nearly 6.3% on Tuesday following the regulatory update.
Over the past year, Intellia Therapeutics’ shares have surged 46.6% compared with the industry’s 17.2% rise.
Image Source: Zacks Investment Research
Recent Developments for NTLA’s Nex-z
In October 2025, Intellia halted dosing and patient enrollment in its late-stage MAGNITUDE and MAGNITUDE-2 studies, which were evaluating nex-z for ATTR amyloidosis with cardiomyopathy (ATTR-CM) and ATTRv-PN, respectively.
The studies were halted after a patient experienced grade 4 liver transaminase elevations and increased total bilirubin following dosing with nex-Z and later died.
This triggered a clinical hold by the FDA on the IND and raised widespread concerns about the safety and future of the program.
Intellia has aligned with the FDA on specific study modifications and risk-mitigation measures for MAGNITUDE-2, including enhanced liver safety monitoring. With the removal of the clinical hold, NTLA intends to resume patient enrollment and dosing in the late-stage study as promptly as possible.
The company is also working with the regulatory authorities regarding the clinical hold on the late-stage MAGNITUDE study and will provide an update once a regulatory path forward is established.
Nex-z, Intellia’s lead pipeline candidate, is being developed in collaboration with Regeneron Pharmaceuticals (REGN - Free Report) for the treatment of ATTR-CM and ATTRv-PN. Intellia’s top line currently comprises only collaboration revenues from its partners, like Regeneron Pharmaceuticals. While NTLA leads the deal for nex-z, REGN shares 25% of the development costs and commercial profits. Nex-z has previously received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA, along with the Orphan Drug designation from the European Commission.
MAGNITUDE-2 is a randomized, double-blind, placebo-controlled phase III study designed to assess the efficacy and safety of nex-z in patients with ATTRv-PN. Following a protocol amendment, Intellia has increased the planned enrollment from approximately 50 to 60 patients. The study’s primary endpoints include changes in the modified neuropathy impairment score and serum transthyretin levels.
NTLA’s Zacks Rank & Stocks to Consider
Intellia Therapeutics currently carries a Zacks Rank #3 (Hold).
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 50 cents. CSTL shares have risen 56% over the past year.
Castle Biosciences’ earnings beat estimates in three quarters and missed in the remaining quarter, with the average surprise being 66.11%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS’ shares have risen 6.2% over the past year.
Alkermes’ earnings beat estimates in three quarters and missed in the remaining quarter, with the average earnings surprise being 4.58%.
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NTLA Stock Up More Than 6% as FDA Lifts ATTRv-PN Study Clinical Hold
Key Takeaways
Intellia Therapeutics (NTLA - Free Report) announced that the FDA lifted the clinical hold on the investigational new drug application (IND) for the phase III study, MAGNITUDE-2, evaluating nexiguran ziclumeran (nex-z) in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN).
NTLA shares gained nearly 6.3% on Tuesday following the regulatory update.
Over the past year, Intellia Therapeutics’ shares have surged 46.6% compared with the industry’s 17.2% rise.
Image Source: Zacks Investment Research
Recent Developments for NTLA’s Nex-z
In October 2025, Intellia halted dosing and patient enrollment in its late-stage MAGNITUDE and MAGNITUDE-2 studies, which were evaluating nex-z for ATTR amyloidosis with cardiomyopathy (ATTR-CM) and ATTRv-PN, respectively.
The studies were halted after a patient experienced grade 4 liver transaminase elevations and increased total bilirubin following dosing with nex-Z and later died.
This triggered a clinical hold by the FDA on the IND and raised widespread concerns about the safety and future of the program.
Intellia has aligned with the FDA on specific study modifications and risk-mitigation measures for MAGNITUDE-2, including enhanced liver safety monitoring. With the removal of the clinical hold, NTLA intends to resume patient enrollment and dosing in the late-stage study as promptly as possible.
The company is also working with the regulatory authorities regarding the clinical hold on the late-stage MAGNITUDE study and will provide an update once a regulatory path forward is established.
Nex-z, Intellia’s lead pipeline candidate, is being developed in collaboration with Regeneron Pharmaceuticals (REGN - Free Report) for the treatment of ATTR-CM and ATTRv-PN. Intellia’s top line currently comprises only collaboration revenues from its partners, like Regeneron Pharmaceuticals. While NTLA leads the deal for nex-z, REGN shares 25% of the development costs and commercial profits. Nex-z has previously received Orphan Drug and Regenerative Medicine Advanced Therapy designations from the FDA, along with the Orphan Drug designation from the European Commission.
MAGNITUDE-2 is a randomized, double-blind, placebo-controlled phase III study designed to assess the efficacy and safety of nex-z in patients with ATTRv-PN. Following a protocol amendment, Intellia has increased the planned enrollment from approximately 50 to 60 patients. The study’s primary endpoints include changes in the modified neuropathy impairment score and serum transthyretin levels.
NTLA’s Zacks Rank & Stocks to Consider
Intellia Therapeutics currently carries a Zacks Rank #3 (Hold).
A couple of better-ranked stocks in the biotech sector are Castle Biosciences (CSTL - Free Report) , and Alkermes (ALKS - Free Report) , each currently sporting a Zacks Rank #1 (Strong Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Castle Biosciences’ 2026 loss per share have narrowed from $1.06 to 50 cents. CSTL shares have risen 56% over the past year.
Castle Biosciences’ earnings beat estimates in three quarters and missed in the remaining quarter, with the average surprise being 66.11%.
Over the past 60 days, estimates for Alkermes’ 2026 earnings per share have increased from $1.54 to $1.91. ALKS’ shares have risen 6.2% over the past year.
Alkermes’ earnings beat estimates in three quarters and missed in the remaining quarter, with the average earnings surprise being 4.58%.