Intellia (NASDAQ: NTLA) details nex-z trial death and FDA hold status

Rhea-AI Filing Summary

Intellia Therapeutics reported safety updates from its Phase 3 MAGNITUDE and MAGNITUDE-2 trials of nexiguran ziclumeran ("nex-z") for transthyretin amyloidosis. A previously disclosed patient in MAGNITUDE experienced Grade 4 liver transaminase elevations and increased bilirubin, triggering a protocol-defined pause, and the FDA placed a clinical hold on the nex-z Phase 3 programs. The patient later died on November 5, 2025, with the principal investigator attributing the death to septic shock secondary to a perforated duodenal ulcer, with a clinical course that included acute liver injury treated with corticosteroids and supported by autopsy findings.

More than 650 patients with ATTR-CM are enrolled in MAGNITUDE and 47 patients with hereditary ATTRv-PN are enrolled in MAGNITUDE-2. Grade 4 liver transaminase elevations have occurred in less than one percent of MAGNITUDE patients, with no such events in MAGNITUDE-2, and all cases except the fatal one resolved within weeks without reported clinical sequelae. The company also updated its corporate presentation for investor and analyst meetings and plans to provide a further update after finalizing a path forward for nex-z with regulators.

Positive

• None.

Negative

• FDA clinical hold on key nex-z Phase 3 trials following a Grade 4 liver injury case and subsequent patient death in MAGNITUDE increases uncertainty for this ATTR amyloidosis program.

Insights

Biotech clinical development analyst

FDA clinical hold on nex-z Phase 3 after rare severe liver event and one patient death heightens development risk.

Intellia Therapeutics outlines a serious safety signal in its MAGNITUDE Phase 3 trial of nexiguran ziclumeran ("nex-z") for ATTR-CM. A patient developed Grade 4 liver transaminase elevations and increased bilirubin, triggering protocol pausing criteria, and the FDA subsequently imposed a clinical hold on the MAGNITUDE and MAGNITUDE-2 Phase 3 studies. The same patient later died from septic shock secondary to a perforated duodenal ulcer, following a complicated course that included acute liver injury treated with corticosteroids and supported by autopsy findings.

The company provides broader context: more than 650 ATTR-CM patients are enrolled in MAGNITUDE and 47 ATTRv-PN patients in MAGNITUDE-2. Grade 4 liver transaminase elevations have occurred in less than 1% of MAGNITUDE patients, with no such events in MAGNITUDE-2, and all cases besides the fatal one resolved within several weeks without reported clinical sequelae. This suggests the event is rare but clinically significant, and regulators are likely focused on understanding its mechanism and manageability before allowing trials to resume.

Intellia states it plans to provide an update after it finalizes a plan with regulators on the path forward for nex-z, emphasizing that resolving the clinical hold is a key near-term objective. The updated corporate presentation furnished as Exhibit 99.1 indicates an effort to keep investors and analysts informed while the hold remains in place. Subsequent regulatory feedback and any protocol modifications will shape how, and if, these Phase 3 programs continue.

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): January 9, 2026

INTELLIA THERAPEUTICS, INC.

(Exact name of Registrant as Specified in Its Charter)

Delaware		001-37766		36-4785571
(State or Other Jurisdiction of Incorporation)		(Commission File Number)		(IRS Employer Identification No.)
40 Erie Street, Suite 130 Cambridge, Massachusetts				02139
(Address of Principal Executive Offices)				(Zip Code)

Registrant’s Telephone Number, Including Area Code: (857) 285-6200

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class		Trading Symbol(s)		Name of each exchange on which registered
Common Stock (Par Value $0.0001)		NTLA		The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 7.01 Regulation FD Disclosure.

On January 9, 2026, Intellia Therapeutics, Inc. (the “Company”) updated its corporate presentation for use in meetings with investors, analysts and others. A copy of the presentation is furnished as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated herein by reference.

The information under this Item 7.01, including Exhibit 99.1 hereto, is being furnished herewith and shall not be deemed “filed” for the purposes of Section 18 of the Exchange Act, or otherwise subject to the liabilities of that section, nor shall such information be deemed incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such filing.

Item 8.01. Other Events.

As the Company reported on October 27, 2025, Grade 4 liver transaminases and increased total bilirubin were reported in a patient who was dosed with nexiguran ziclumeran (“nex-z”) in the MAGNITUDE trial of nex-z for the treatment of transthyretin (“ATTR”) amyloidosis with cardiomyopathy (“ATTR-CM”). This case met the trial’s protocol-defined pausing criteria, and the United States Food and Drug Administration (the “FDA”) subsequently placed a clinical hold on the Investigational New Drug applications for the MAGNITUDE and MAGNITUDE-2 Phase 3 clinical trials of nex-z.

As previously reported, the patient passed away on November 5, 2025. It was reported by the principal investigator that the patient died due to septic shock secondary to a perforated duodenal ulcer. The patient’s complicated clinical course also included acute liver injury and its treatment with corticosteroids. An autopsy report supported the clinical diagnoses.

To date, more than 650 patients with ATTR-CM are enrolled in MAGNITUDE, and 47 patients with hereditary ATTR amyloidosis with polyneuropathy (“ATTRv-PN”) are enrolled in MAGNITUDE-2. Grade 4 liver transaminase elevations have been reported in less than one percent of all patients enrolled in MAGNITUDE, and no Grade 4 liver transaminase elevations have been reported in MAGNITUDE-2. The onset of each of the Grade 4 events occurred within 3-5 weeks of dosing and, apart from the aforementioned case, resolved within several weeks of onset and without reported clinical sequelae.

The Company plans to provide an update after it has finalized a plan with regulators on the path forward for nex-z.

Forward-Looking Statements

This Current Report on Form 8-K and certain of the materials furnished or filed herewith contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, as amended. The words “may,” “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “target” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.

These forward-looking statements include, but are not limited to, express or implied statements regarding Intellia’s beliefs and expectations regarding: the safety, tolerability, efficacy, success and advancement of its clinical programs for nex-z for ATTR amyloidosis, including its MAGNITUDE Phase 3 study of nex-z for the treatment of ATTR-CM and its MAGNITUDE-2 Phase 3 study of nex-z for the treatment of ATTRv-PN; and its ability to resolve the clinical hold and finalize a plan with regulators on the path forward for nex-z.

Any forward-looking statements in this current report on Form 8-K are based on management’s current expectations and beliefs of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to: risks related to Intellia’s ability to protect and maintain its intellectual property position; risks related to valid third party intellectual property; risks related to Intellia’s relationship with third parties, including its licensors and licensees; risks related to the ability of its licensors to protect and maintain their intellectual property position; uncertainties related to regulatory agencies’ evaluation of regulatory filings and other information related to our product candidates, including nex-z; uncertainties related to the authorization, initiation and conduct of studies and other development requirements for our product candidates, including uncertainties related to regulatory approvals to conduct clinical trials; the risk that any one or more of Intellia’s product candidates, including nex-z, will not be successfully developed and commercialized; the risk that the results of preclinical studies or clinical studies will not be predictive of future results in connection with future studies for the same product candidate or Intellia’s other product candidates; and risks related to Intellia’s reliance on collaborations, including that its collaboration with Regeneron Pharmaceuticals, Inc. will not continue or will not be successful. For a discussion of these and other risks and uncertainties, and other important factors, any of which could cause Intellia’s actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors”

in Intellia’s most recent annual report on Form 10-K and quarterly report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in Intellia’s other filings with the Securities and Exchange Commission. All information in this current report on Form 8-K is as of the date of the report, and Intellia undertakes no duty to update this information unless required by law.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits

Exhibit No.		Description
99.1		Corporate Presentation
104		Cover Page Interactive Data File (embedded within the Inline XBRL document)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

				Intellia Therapeutics, Inc.
Date: January 9, 2026				By:		/s/ John M. Leonard
				Name:		John M. Leonard
				Title:		Chief Executive Officer and President

FAQ

What did Intellia Therapeutics (NTLA) disclose about the nex-z MAGNITUDE trials?

Intellia disclosed that in the MAGNITUDE Phase 3 trial of nexiguran ziclumeran ("nex-z") for ATTR-CM, a patient experienced Grade 4 liver transaminase elevations and increased bilirubin, triggering protocol-defined pausing criteria and leading the FDA to place a clinical hold on the MAGNITUDE and MAGNITUDE-2 Phase 3 studies.

What were the circumstances of the patient death reported by Intellia (NTLA)?

The company reported that the patient died on November 5, 2025. According to the principal investigator, the cause of death was septic shock secondary to a perforated duodenal ulcer, after a complicated clinical course that included acute liver injury treated with corticosteroids, with an autopsy supporting the clinical diagnoses.

How many patients are enrolled in Intellia's nex-z MAGNITUDE and MAGNITUDE-2 trials?

More than 650 patients with ATTR-CM are enrolled in the MAGNITUDE trial, and 47 patients with hereditary ATTR amyloidosis with polyneuropathy (ATTRv-PN) are enrolled in the MAGNITUDE-2 Phase 3 trial.

What liver safety data did Intellia (NTLA) report for nex-z?

Intellia stated that Grade 4 liver transaminase elevations have occurred in less than one percent of all patients enrolled in MAGNITUDE, with no Grade 4 liver transaminase elevations reported in MAGNITUDE-2. For all Grade 4 events except the fatal case, onset occurred within 3–5 weeks of dosing and resolved within several weeks without reported clinical sequelae.

What are Intellia Therapeutics' next steps regarding the nex-z clinical hold?

The company indicated that it plans to provide an update after it has finalized a plan with regulators on the path forward for nex-z, following the FDA clinical hold on the MAGNITUDE and MAGNITUDE-2 Phase 3 trials.

What additional materials did Intellia (NTLA) provide with this 8-K?

Intellia updated its corporate presentation for use in meetings with investors, analysts and others, and furnished it as Exhibit 99.1. The company noted that this information is being furnished, not filed, under the Exchange Act.