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 (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 (NTLA) reported an insider transaction by its EVP and Chief Scientific Officer. On October 1, 2025, the officer executed a mandatory sell-to-cover of 31 shares of common stock at $17.38 to satisfy tax withholding upon RSU vesting, which the filing notes was not a voluntary trade.
Following the transaction, the officer directly beneficially owned 105,184 shares of Intellia common stock.
Michael P. Dube, Vice President and Chief Accounting Officer of Intellia Therapeutics, Inc. (NTLA), reported a Form 4 disclosing a mandatory tax-withholding sale related to RSU vesting. On 10/01/2025 the reporting person had 1,871 shares sold (transaction code S(1)) at $17.38 per share to satisfy tax withholding obligations arising from RSU vesting. After the sale, the reporting person beneficially owned 55,266 shares. The Form 4 was signed by an attorney-in-fact and dated 10/03/2025. The filing describes the sale as non-volitional and linked solely to tax withholding.
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.
William J. Chase, a director of Intellia Therapeutics, Inc. (NTLA), reported an open-market purchase of 100,000 shares of the issuer's common stock on 08/20/2025. The shares were bought in accordance with the company's trading policies at a weighted average price of $10.03, with transaction prices ranging from $9.97 to $10.04. Following the purchase, the reporting person beneficially owned 134,693 shares. The Form 4 was filed as a single-person report and signed by attorney-in-fact James Basta on 08/22/2025.
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.