Intellia Therapeutics, Inc. filings document the business, governance and capital structure of a Nasdaq-listed clinical-stage biopharmaceutical company developing CRISPR-based therapies. Its Form 8-K reports record quarterly financial results and business updates, clinical and regulatory disclosures for lonvo-z in hereditary angioedema, nex-z in ATTR amyloidosis, and related FDA communications.
The filing record also includes common stock financing disclosures, including an underwritten public offering and amendments to an at-the-market sales program. Proxy materials describe annual meeting matters, executive compensation, equity awards and board governance, while bylaw amendments and other corporate filings address shareholder proposal procedures, forum provisions and registered common stock listed on The Nasdaq Global Market.
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 is a genome-editing biotech developing in vivo CRISPR medicines, led by two Phase 3 programs. Lonvoguran ziclumeran (lonvo-z, NTLA-2002) targets hereditary angioedema with a one-time IV treatment; the HAELO Phase 3 trial fully enrolled 80 patients, with topline data expected by mid-2026 and a planned U.S. launch in the first half of 2027, following a BLA filing in the second half of 2026.
Nexiguran ziclumeran (nex-z, NTLA-2001) targets ATTR amyloidosis. The MAGNITUDE Phase 3 cardiomyopathy trial is on FDA clinical hold after a case of severe liver injury and a subsequent patient death, while the FDA has lifted the hold on the MAGNITUDE-2 Phase 3 polyneuropathy trial. Earlier Phase 1 data showed deep, durable TTR reductions and signs of disease stabilization. Intellia also advances additional CRISPR and cell-therapy collaborations, including a co-development deal with Regeneron and licensed ex vivo programs, and highlights extensive regulatory, manufacturing, competition and IP risks typical for first-wave CRISPR therapies.
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.
The Goldman Sachs Group, Inc. and Goldman Sachs & Co. LLC report beneficial ownership of 3,157,178.33 shares of Intellia Therapeutics common stock, representing 2.7% of the class as of 12/31/2025.
All shares are reported with shared voting and dispositive power, with no sole voting or dispositive authority. The firms state the securities were acquired and are held in the ordinary course of business and not for the purpose of changing or influencing control of Intellia. The filing confirms their ownership is below 5% of the outstanding common stock.
Contrarius Investment Management Limited and Contrarius Investment Management (Bermuda) Limited report beneficial ownership of 714,480 shares of Intellia Therapeutics, Inc.0.6% of the class as of the event date.
The firms have shared voting and dispositive power over all 714,480 shares and no sole power. They state that the securities were acquired and are held in the ordinary course of business, not for the purpose of changing or influencing control of Intellia. The filing is made jointly because the two entities may be deemed a group under section 13(d)(3).
State Street Corporation has filed a Schedule 13G reporting beneficial ownership of Intellia Therapeutics common stock. It reports beneficial ownership of 6,418,836 shares, representing 5.5% of the outstanding common stock as of the event date.
State Street reports no sole voting or dispositive power, with shared voting power over 6,045,757 shares and shared dispositive power over 6,418,836 shares. The holdings are reported as being acquired and held in the ordinary course of business, not for the purpose of changing or influencing control of Intellia. Several State Street Global Advisors and related investment adviser subsidiaries are identified as relevant entities.
ARK Investment Management LLC and its founder Catherine D. Wood report beneficial ownership of 14,207,324 shares of Intellia Therapeutics, Inc. common stock, representing 12.27% of the class as of 12/31/2025.
ARK has sole voting power over 13,162,242 shares and shared voting power over 280,265 shares. It has sole dispositive power over all 14,207,324 shares. Wood is reported to share voting power over 13,442,507 shares and share dispositive power over all 14,207,324 shares through her control of ARK.
The filing states these securities are held in the ordinary course of business and not for the purpose of changing or influencing control of Intellia. It also notes that among ARK’s clients, only ARK Innovation ETF holds more than 5% of this class.
The Vanguard Group filed an amended Schedule 13G reporting beneficial ownership of 13,010,001 shares of Intellia Therapeutics Inc common stock, representing 11.23% of the class as of 12/31/2025.
Vanguard reports shared voting power over 864,210 shares and shared dispositive power over all 13,010,001 shares, with no sole voting or dispositive power. The filing states the shares are held in the ordinary course of business and not for the purpose of changing or influencing control of Intellia.
Vanguard also notes an internal realignment effective 01/12/2026, after which certain subsidiaries or business divisions that are deemed to have beneficial ownership may report their holdings separately, while continuing the same investment strategies.
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.