Every 8-K that Intellia Therapeutics, Inc (NTLA) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow NTLA and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full NTLA filings page.
Intellia Therapeutics, Inc. (NTLA) reports that the U.S. FDA has accepted its Biologics License Application for lonvoguran ziclumeran (lonvo-z) for hereditary angioedema and granted Priority Review with a Prescription Drug User Fee Act target action date of March 10, 2027. FDA also indicated it is not currently planning to hold an advisory committee meeting on the application. The BLA is supported by a global Phase 3 HAELO trial of 80 patients, where a single 50 mg dose of lonvo-z achieved an 87% reduction in mean monthly attacks versus placebo and 62% of treated patients were attack-free and HAE-therapy-free over six months. All treatment-emergent adverse events in the lonvo-z arm were mild or moderate with no serious adverse events reported. Intellia highlights that, if approved, lonvo-z could become the first in vivo CRISPR-based therapy and the only one-time treatment for HAE.
Intellia Therapeutics, Inc. (NTLA) entered into a senior secured Credit Agreement with OrbiMed-affiliated lenders providing a five-year credit facility of up to $400 million. An initial $75 million was drawn at closing, with additional tranches tied to regulatory, revenue and equity fundraising milestones, plus an uncommitted $100 million incremental option.
The facility matures on September 4, 2031. Loans bear monthly interest at the one-month SOFR (with a 3.00% floor) plus a 6.15% margin, implying a minimum annual rate of 9.15%, plus customary fees. Obligations are secured by first‑priority liens on substantially all company assets, including intellectual property, and are subject to mandatory prepayments from certain debt financings, asset sales and casualty proceeds.
Covenants include maintaining at least $50 million of liquidity in controlled accounts until FDA approval of the BLA for lonvoguran ziclumeran (lonvo‑z), and thereafter satisfying revenue, market capitalization or cash-balance tests. Negative covenants restrict additional debt, liens, M&A, asset sales, licensing and dividends, while permitting certain synthetic royalty transactions. Proceeds are for working capital and general corporate purposes.
Intellia Therapeutics reported second quarter 2026 results and major progress in its gene-editing pipeline. In the Phase 3 HAELO trial for hereditary angioedema, one-time treatment lonvo-z met its primary endpoint, reducing attacks by 87% versus placebo over weeks 5–28, with a mean monthly attack rate of 0.26 versus 2.10. Key secondary endpoints all reached statistical significance, including 62% of lonvo-z patients being attack- and therapy-free versus 11% on placebo. Safety findings showed only mild or moderate treatment emergent adverse events and no serious adverse events in the lonvo-z arm. Intellia plans a biologics license application to the FDA with expected acceptance in the second half of 2026 and a potential U.S. launch in the first half of 2027.
For its ATTR amyloidosis program, Intellia advanced Phase 3 MAGNITUDE and MAGNITUDE-2 trials for nex-z and aims to complete MAGNITUDE-2 enrollment in the second half of 2026. A genomic analysis linked higher liver transaminase elevations to one human leukocyte antigen allele, guiding HLA genotyping in ongoing studies. Financially, collaboration revenue was $7,659 thousand in the quarter, research and development expenses were $82,595 thousand, general and administrative expenses were $37,824 thousand, and net loss was $106,634 thousand. Cash, cash equivalents and marketable securities totaled $628,354 thousand at June 30, 2026, which Intellia expects will fund operations at least into 2028.
Intellia Therapeutics reported additional positive Phase 3 data from its global HAELO trial of lonvoguran ziclumeran (lonvo-z) for hereditary angioedema. The study previously met its primary endpoint, showing an 87% reduction in mean monthly attacks in the lonvo-z arm versus placebo during weeks 5 to 28. In that period, 62% of lonvo-z patients were attack free and therapy free compared with 11% on placebo. New key secondary data showed the mean monthly rate of attacks requiring on-demand treatment was 0.19 in the lonvo-z arm versus 1.79 on placebo, an 89% reduction. All treatment-emergent adverse events in the lonvo-z arm were mild or moderate, with no serious adverse events observed. Intellia has initiated a rolling biologics license application for lonvo-z with the FDA and continues to anticipate regulatory approval and a U.S. launch in the first half of 2027.
Intellia Therapeutics, Inc. reported the results of its Annual Meeting of stockholders held on June 9, 2026. Stockholders voted on three proposals that had been described in the company’s Proxy Statement.
For the election of directors, Muna Bhanji received 57,065,465 votes for and 1,610,941 against, Brian Goff received 46,090,644 for and 12,582,130 against, and Jesse Goodman received 43,004,221 for and 15,686,289 against, each with additional abstentions and 30,124,178 broker non-votes. A separate proposal received 87,833,534 votes for, 779,540 against, and 249,592 abstentions, with no broker non-votes. Another proposal received 44,806,637 votes for, 13,821,404 against, 110,447 abstentions, and 30,124,178 broker non-votes. No other matters were submitted to stockholders.
Intellia Therapeutics reported first quarter 2026 results alongside major clinical milestones. In the Phase 3 HAELO trial, a one-time infusion of lonvo-z reduced hereditary angioedema attacks by 87% versus placebo over six months, with 62% of treated patients attack free and therapy free.
Intellia has begun a rolling BLA submission for lonvo-z and is targeting a potential U.S. launch in the first half of 2027. The FDA lifted clinical holds on the MAGNITUDE and MAGNITUDE-2 Phase 3 trials for nex-z in ATTR amyloidosis, and patient screening has resumed.
Financially, Q1 2026 collaboration revenue was $15.0 million and net loss was $96.2 million, or $0.81 per share. Cash, cash equivalents and marketable securities were $517.2 million as of March 31, 2026, and an April underwritten equity offering added approximately $207 million in gross proceeds, supporting operations at least into 2028.
Intellia Therapeutics entered an underwriting agreement for a public offering of 16,744,187 shares of common stock at $10.75 per share, with underwriters exercising a 30‑day option for an additional 2,511,628 shares. The company estimates net proceeds of about $194.6 million.
Intellia plans to use the funds to advance clinical development and prepare for commercial launch of its lead programs, support other pipeline research, pursue potential acquisitions, and for working capital and general corporate purposes. It expects these proceeds, together with existing cash and collaboration funding, to fund operations at least into 2028.
Intellia also reported preliminary unaudited cash, cash equivalents and marketable securities of about $517.2 million as of March 31, 2026, including roughly $33.6 million in net proceeds from at‑the‑market stock sales during the quarter.
Intellia Therapeutics reported positive Phase 3 HAELO trial results for its in vivo CRISPR gene-editing candidate lonvoguran ziclumeran (lonvo-z) in hereditary angioedema. In the 80‑patient, placebo‑controlled study, lonvo-z achieved an 87% reduction in HAE attack rate versus placebo between weeks 5 and 28 and 62% of treated patients were completely attack‑free and off prophylactic therapy in that period. All 52 patients in the lonvo-z arm saw attack‑rate reductions, and early crossover data showed attack rates approaching zero in both arms. Safety appeared favorable, with no serious adverse events or grade ≥3 treatment‑emergent events reported in the lonvo-z group and mainly mild or moderate infusion‑related reactions. Intellia has initiated a rolling biologics license application with the FDA and is preparing to complete the submission in the second half of 2026 and for a potential U.S. launch in the first half of 2027, if approved.
Intellia Therapeutics, Inc. amended its bylaws, effective April 7, 2026. The changes let shareholders fix facially obvious errors in timely notices of director nominations or other proposals, and require the company to alert them when such deficiencies exist so they can be cured.
The updated bylaws also make federal district courts in the United States the exclusive forum for complaints asserting causes of action under the Securities Act of 1933 or the Securities Exchange Act of 1934, unless Intellia agrees in writing to a different forum.
Intellia Therapeutics expanded its at-the-market stock offering program with Jefferies, increasing capacity from $750,000,000 to $1,035,316,650. The company has already sold about $635,316,650 of common stock and will use a new prospectus to offer up to an additional $400,000,000 in shares on a discretionary basis, paying Jefferies up to 3% of gross proceeds.
Separately, the FDA removed the clinical hold on the MAGNITUDE Phase 3 trial of nexiguran ziclumeran for transthyretin amyloidosis with cardiomyopathy after prior Grade 4 liver enzyme elevations. Intellia and the FDA agreed on added liver and cardiac safety exclusions and enhanced monitoring, allowing enrollment activities in both MAGNITUDE and MAGNITUDE-2 to resume.
Intellia Therapeutics reported fourth-quarter and full-year 2025 results alongside major pipeline updates. Collaboration revenue for Q4 2025 was $23.0 million, up from $12.9 million a year earlier. Research and development expenses fell to $88.7 million from $116.9 million, and net loss narrowed to $95.8 million from $128.9 million.
The company ended 2025 with $605.1 million in cash, cash equivalents and marketable securities, which it expects to fund operations into the second half of 2027 and through the anticipated U.S. launch of lonvo-z for hereditary angioedema. Topline HAELO Phase 3 data for lonvo-z are expected by mid-2026, with a planned BLA submission in the second half of 2026 and a potential U.S. launch in the first half of 2027.
For nex-z in transthyretin amyloidosis, the FDA has lifted the clinical hold on the MAGNITUDE-2 Phase 3 trial, and Intellia is reactivating global sites with enrollment completion expected in the second half of 2026. Engagement with the FDA continues to resolve the remaining clinical hold on the MAGNITUDE Phase 3 trial for ATTR-CM.
Intellia Therapeutics reports that the U.S. FDA has removed the clinical hold on the investigational new drug application for its MAGNITUDE-2 Phase 3 trial of nexiguran ziclumeran ("nex-z") in patients with hereditary transthyretin amyloidosis with polyneuropathy (ATTRv-PN). The FDA had placed MAGNITUDE-2 and the related MAGNITUDE Phase 3 cardiomyopathy (ATTR-) trial on hold after a MAGNITUDE patient experienced Grade 4 liver transaminase elevations with increased total bilirubin and subsequently died, triggering protocol-defined pausing criteria. Intellia has now agreed with the FDA on study modifications and mitigation measures, including enhanced liver safety monitoring, and is working with investigators, ethics committees, regulators and other stakeholders to restart enrollment in MAGNITUDE-2.
The FDA clinical hold on the MAGNITUDE Phase 3 trial in ATTR- remains in place, and Intellia’s engagement with the agency on a path forward for that program is ongoing. The company plans to provide an update once alignment with the FDA is reached on next steps for the cardiomyopathy trial.
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.
Intellia Therapeutics (NTLA) reported new clinical updates across two in vivo CRISPR programs. For hereditary angioedema, a pooled Phase 1/2 analysis of 32 patients receiving a one-time 50 mg dose of lonvoguran ziclumeran (lonvo-z) showed a mean 89% reduction in plasma kallikrein at month 24. 31 of 32 patients (97%) were attack-free and off long-term prophylaxis as of the August 29, 2025 cut-off, with a safety profile described as well tolerated up to three years of follow-up. The global Phase 3 HAELO trial completed enrollment in September 2025, with topline data expected by mid-2026.
For transthyretin amyloidosis with cardiomyopathy, the Phase 1 trial of nexiguran ziclumeran (nex-z) enrolled 36 patients and showed sustained serum TTR reduction; among nine patients at 36 months, the mean reduction was 87%. At 24 months, stability or improvement was seen in 70% (NT-proBNP), 85% (hs‑Troponin T), and 69% (6MWT), with 81% stable or improved NYHA class. A matched-cohort mortality analysis reported HR 0.27 (p=0.009). The FDA placed a clinical hold on the Phase 3 MAGNITUDE and MAGNITUDE‑2 trials on October 29, 2025.
Intellia Therapeutics (NTLA) filed an 8-K announcing its financial results and business updates for the quarter ended September 30, 2025. The company furnished a press release as Exhibit 99.1 detailing the announcement.
The information provided under Item 2.02 is furnished, not deemed filed under Section 18 of the Exchange Act, and may be incorporated by reference only if a subsequent filing specifically references it.
Intellia Therapeutics (NTLA) reported an FDA clinical hold on the Investigational New Drug applications for its MAGNITUDE and MAGNITUDE‑2 Phase 3 trials of nexiguran ziclumeran (nex‑z). The company was verbally informed on October 29, 2025, and the FDA indicated it will issue a formal Clinical Hold Letter within 30 calendar days.
The hold follows a previously disclosed patient case with Grade 4 liver transaminases and increased total bilirubin in the MAGNITUDE trial. On October 27, 2025, Intellia had already paused dosing and screening in both Phase 3 studies under the trial’s protocol‑defined pausing criteria. Intellia stated it intends to work with the FDA to address the hold as expeditiously as possible.
Intellia Therapeutics temporarily paused dosing and screening in its Phase 3 MAGNITUDE (ATTR-CM) and MAGNITUDE-2 (ATTRv-PN) trials of nexiguran ziclumeran (nex-z) after a safety event met protocol-defined pausing criteria.
The action follows an October 24 report of Grade 4 liver transaminases and increased total bilirubin in a patient dosed on September 30 in MAGNITUDE. More than 650 patients with ATTR-CM are enrolled in MAGNITUDE and 47 patients with ATTR-PN are enrolled in MAGNITUDE-2; over 450 patients are estimated to have been dosed with nex-z. The company furnished a press release as Exhibit 99.1 and included standard forward-looking statements regarding the ability to resume and complete these studies.
Intellia Therapeutics reported interim clinical data for its in vivo CRISPR gene editing therapy "nex-z" (NTLA-2001) in hereditary transthyretin (ATTR) amyloidosis with polyneuropathy. In an open-label Phase 1 study, a one-time dose at or above 0.3 mg/kg (n=33) produced a mean serum TTR reduction of 92% at 24 months, corresponding to a mean absolute TTR level of 17.3 µg/mL (95% CI 12.5–22.2). Among 12 patients followed to 36 months, mean reduction was 90% with a mean absolute level of 20 µg/mL (95% CI 11.2–28.8).
Clinical measures such as quality-of-life for diabetic neuropathy (QoL-DN) and neurofilament light chain (NfL) trended toward improvement, and 89% of patients showed improvement or stability in PND scores through 24 months versus baseline. The filing also reiterates standard development and collaboration risks, including regulatory and development uncertainties and reliance on partners.
Intellia Therapeutics (NTLA) filed an 8-K current report dated 7 Aug 2025 covering two disclosure items.
- Item 2.02 – Results of Operations: The company furnished a press release (Ex. 99.1) announcing Q2 2025 financial results and business updates for the period ended 30 Jun 2025. Specific revenue, EPS or guidance figures are not included in the filing; the information is furnished, not filed, and may be incorporated into future SEC filings only if explicitly referenced.
- Item 5.02 – Executive Change: Executive Vice President & Chief Medical Officer Dr. David Lebwohl, M.D. will retire effective 7 Aug 2026. He will remain CMO until a successor is appointed and stay employed through the retirement date. Upon departure, his equity awards will follow the terms of the company’s Amended & Restated Retirement Policy (filed as Ex. 10.30 to the 2022 10-K).
No other material events, financial tables, or strategic transactions are disclosed in this report.