# EDGAR Filing Document

**Accession Number:** 0001125345
**File Stem:** 0001125345-26-000009
**Filing Date:** 2026-2
**Character Count:** 12045
**Document Hash:** dbc16186b22a9cde29a3dbb51f24901c
**Contains OCR:** False
**Source Format:** 

## Filing Content

## Filing Summary
**0001125345-26-000009.hdr.sgml**: 20260224

**ACCESSION NUMBER**: 0001125345-26-000009

**CONFORMED SUBMISSION TYPE**: 8-K

**PUBLIC DOCUMENT COUNT**: 14

**CONFORMED PERIOD OF REPORT**: 20260223

**ITEM INFORMATION**: Other Events

**FILED AS OF DATE**: 20260224

**DATE AS OF CHANGE**: 20260223

**FILER**: 

**COMPANY DATA:**
- **COMPANY CONFORMED NAME:** MACROGENICS INC
- **CENTRAL INDEX KEY:** 0001125345
- **STANDARD INDUSTRIAL CLASSIFICATION:** PHARMACEUTICAL PREPARATIONS [2834]
- **ORGANIZATION NAME:** 03 Life Sciences
- **EIN:** 000000000
- **STATE OF INCORPORATION:** DE
- **FISCAL YEAR END:** 1231

**FILING VALUES:**
- **FORM TYPE:** 8-K
- **SEC ACT:** 1934 Act
- **SEC FILE NUMBER:** 001-36112
- **FILM NUMBER:** 26666933

**BUSINESS ADDRESS:**
- **STREET 1:** 9704 MEDICAL CENTER DRIVE
- **CITY:** Rockville
- **STATE:** MD
- **ZIP:** 20850
- **BUSINESS PHONE:** 301-251-5172

**MAIL ADDRESS:**
- **STREET 1:** 9704 MEDICAL CENTER DRIVE
- **CITY:** ROCKVILLE
- **STATE:** MD
- **ZIP:** 20850

?xml version='1.0' encoding='ASCII'? mgnx-20260223

**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): February 23, 2026

**MACROGENICS, INC.**

 *(Exact Name of Registrant as Specified in Charter)*

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| | | | |
|:---|:---|:---|:---|
| **Delaware** | **Delaware** | **001-36112** | **06-1591613** |
| *(State or Other Jurisdiction of Incorporation)* | *(State or Other Jurisdiction of Incorporation)* | *(Commission<br>File Number)* | *(IRS Employer*<br> *Identification No.)* |
| **9704 Medical Center Drive** | **9704 Medical Center Drive** | | |
| **Rockville,** | **Maryland** | **20850** | **20850** |
| (Address of Principal Executive Offices) | (Address of Principal Executive Offices) | (Zip Code) | (Zip Code) |

---

Registrant's telephone number, including area code: **(301) 251-5172**

**Not applicable** 

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

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

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| | | |
|:---|:---|:---|
| **Title of each class** | **Trading Symbol(s)** | **Name of each exchange on which registered** |
| Common Stock, par value $0.01 per share | MGNX | Nasdaq Global Select Market |

---

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 (see General Instruction A.2. below):

☐ 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))

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. ☐

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| | |
|:---|:---|
| **Item 8.01** | **Other Events.** |

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On February 23, 2026, MacroGenics, Inc. issued a press release announcing that the U.S. Food and Drug Administration (the "***FDA***") has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers.

A copy of the press release is attached to this Current Report on Form 8-K as Exhibit 99.1 and is incorporated by reference into this Item 8.01.

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| | |
|:---|:---|
| **Item 9.01** | **Financial Statements and Exhibits** |

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<br>**(d) Exhibits.**<br>

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| | |
|:---|:---|
| **Exhibit Number** | **Description of Exhibit** |
| <u>[99.1](exhibit991_lorigerlimabcli.htm)</u> | <u>[Press Release dated](exhibit991_lorigerlimabcli.htm)[February 23](exhibit991_lorigerlimabcli.htm)[, 202](exhibit991_lorigerlimabcli.htm)[6](exhibit991_lorigerlimabcli.htm)</u> |
| 104 | Cover Page Interactive Data (embedded within the Inline XBRL document) |

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**SIGNATURE**

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 hereunto duly authorized.

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| | |
|:---|:---|
| &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;Date: February 23, 2026 | &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;MACROGENICS, INC. |
|  | By: <u>/s/ Jeffrey Peters</u><br>&nbsp;&nbsp;&nbsp;&nbsp; Jeffrey Peters<br>&nbsp;&nbsp;&nbsp;&nbsp; Senior Vice President and General Counsel |

---

## Exhibit 99.1

**Exhibit 99.1**

![macrogenics20logo_jpgormata.jpg](macrogenics20logo_jpgormata.jpg)

**MacroGenics Announces Pausing of Enrollment of New Study Participants in LINNET Trial**

FDA has placed partial clinical hold on LINNET study of lorigerlimab in gynecologic cancer

**ROCKVILLE, MD., February 23, 2026 (GLOBE NEWSWIRE)** — MacroGenics, Inc. (NASDAQ: MGNX), a clinical-stage biopharmaceutical company focused on developing innovative antibody-based therapeutics for the treatment of cancer, today announced that the U. S. Food and Drug Administration (FDA) has placed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4, in patients with gynecologic cancers. Under the partial clinical hold, no new patients will be enrolled in the LINNET study until the partial hold is lifted by the FDA. Current study participants may continue to receive study drug.

The FDA's partial clinical hold was initiated following the Company's recent notification to the FDA of a temporary pause in enrollment of new participants in the LINNET trial due to the occurrence of recent safety events. The safety events that prompted the enrollment pause occurred across four patients and included Grade 4 thrombocytopenia (N=2), Grade 4 myocarditis (N=1), and Grade 4 neutropenia and concurrent septic shock (N=1) which led to a Grade 5 event. To date, 41 study participants have been dosed at 6 mg/kg every 3 weeks across the platinum-resistant ovarian cancer (PROC) and clear cell gynecologic cancer (CCGC) cohorts.

"At MacroGenics, our top priority is patient safety," said Eric Risser, President and CEO. "MacroGenics is fully committed to working closely with the FDA to resolve the partial clinical hold and we intend to resume study enrollment as soon as possible."

**About the LINNET Study**

The LINNET study is evaluating lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4, as monotherapy in a Simon two-stage trial in eligible patients with PROC who have received up to three prior lines of therapy. If a predefined activity threshold is met in the first stage — based on approximately 20 patients — the study may expand to enroll an additional 20 patients. The study was also designed to enroll up to 20 patients with CCGC who have received at least one prior line of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints.

**About MacroGenics, Inc.**

MacroGenics (the Company) is a biopharmaceutical company focused on developing innovative monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms, which have applicability across broad therapeutic

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**Exhibit 99.1**

domains. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics and the MacroGenics logo are trademarks or registered trademarks of MacroGenics, Inc.

**Cautionary Note on Forward-Looking Statements** 

Any statements in this press release about future expectations, plans and prospects for MacroGenics ("Company"), including statements about the Company's strategy, future operations, clinical development of and regulatory plans for the Company's therapeutic candidates, expected timing of the release of clinical updates and safety and efficacy data for the Company's ongoing clinical trials and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "potential," "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy, including our ability to execute on our key strategic priorities for 2025 and 2026, constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the risk of delays or failure in reaching an agreement with the FDA regarding the release of a clinical hold, risks that TZIELD, lorigerlimab, ZYNYZ, or any other product candidate's revenue, expenses and costs may not be as expected, risks relating to TZIELD, lorigerlimab, ZYNYZ, or any other product candidate's market acceptance, competition, reimbursement and regulatory actions; future data updates, including timing and results of efficacy and safety data with respect to product candidates in ongoing clinical trials; our ability to provide manufacturing services to our customers; the uncertainties inherent in the initiation and enrollment of future clinical trials; the availability of financing to fund the internal development of our product candidates; expectations of expanding ongoing clinical trials; expectations for the timing and steps required in the regulatory review process; expectations for regulatory approvals; expectations of future milestone payments; the impact of competitive products; our ability to enter into agreements with strategic partners and other matters that could affect the availability or commercial potential of the Company's product candidates; business, economic or political disruptions due to catastrophes or other events, including natural disasters, terrorist attacks, civil unrest and actual or threatened armed conflict, or public health crises; costs of litigation and the failure to successfully defend lawsuits and other claims against us; and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.

**CONTACTS**

Jim Karrels, Senior Vice President, CFO

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**Exhibit 99.1**

1-301-251-5172

info@macrogenics.com

Argot Partners

1-212-600-1902

macrogenics@argotpartners.com

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