FDA lifts hold on MacroGenics (NASDAQ: MGNX) LINNET gynecologic cancer trial
Filing Impact
Filing Sentiment
Form Type
8-K
Rhea-AI Filing Summary
MacroGenics, Inc. announced that the U.S. Food and Drug Administration has removed the partial clinical hold on its Phase 2 LINNET study of lorigerlimab in gynecologic cancers. This allows the company to resume enrolling new participants under a revised protocol with added safeguards for potential blood and heart-related side effects.
The LINNET study is testing single-agent lorigerlimab, a bispecific DART® antibody targeting PD-1 and CTLA-4, in up to about 60 patients with platinum-resistant ovarian cancer or clear cell gynecologic cancers who have received prior therapies. To date, 41 participants have been treated in LINNET and over 300 across lorigerlimab’s Phase 1 and Phase 2 trials. MacroGenics expects to provide a clinical update on the lorigerlimab program around mid-2026.
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Insights
FDA’s lift of the partial clinical hold lets MacroGenics fully resume lorigerlimab’s Phase 2 LINNET trial under tighter safety controls.
The removal of the partial clinical hold on the LINNET study means MacroGenics can again enroll new patients with platinum-resistant ovarian and clear cell gynecologic cancers. Previously treated participants were already continuing therapy, so this change primarily affects future recruitment and study momentum.
The updated protocol adds extra risk‑mitigation for hematologic and cardiac toxicities, reflecting FDA’s focus on safety for dual PD‑1/CTLA‑4 targeting agents. To date, 41 patients have received lorigerlimab in LINNET and over 300 across all trials, giving a growing safety and activity dataset.
The company plans a mid‑2026 program update, which will be an important point to review objective response data and tolerability. Outcomes will shape lorigerlimab’s potential in difficult‑to‑treat gynecologic cancers and inform any later‑stage development plans.
8-K Event Classification
2 items: 8.01, 9.01
2 items
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, and exhibit attachments filed with this report.
Key Figures
Planned LINNET enrollment: up to approximately 60 participants
LINNET participants dosed: 41 participants
Total lorigerlimab participants: over 300 participants
+1 more
4 metrics
Planned LINNET enrollment
up to approximately 60 participants
Phase 2 LINNET study target size
LINNET participants dosed
41 participants
Patients dosed to date in LINNET
Total lorigerlimab participants
over 300 participants
Dosed across all Phase 1 and Phase 2 studies
Program update timing
mid-2026
Expected lorigerlimab program update
Key Terms
partial clinical hold, bispecific DART® molecule, platinum-resistant ovarian cancer, objective response rate, +1 more
5 terms
partial clinical hold regulatory
"the U. S. Food and Drug Administration (FDA) has removed the partial clinical hold on the Company’s Phase 2 LINNET study"
A partial clinical hold is a temporary restriction imposed by health regulators that pauses certain parts of a medical trial while allowing others to continue. For investors, it signals potential delays or issues with a company's development of new treatments, which can impact future growth prospects. It’s like putting a project on hold in some areas while others keep moving forward.
bispecific DART® molecule medical
"lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4"
platinum-resistant ovarian cancer medical
"patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC)"
A form of ovarian cancer that stops responding to standard platinum-based chemotherapy, typically when the disease returns within about six months after treatment; think of it like a pest becoming resistant to a once-effective pesticide. It matters to investors because this resistance creates a large unmet medical need, shaping demand for new drugs, clinical trial strategies, regulatory priority and potential pricing — all of which can materially affect company value and market opportunity.
objective response rate medical
"The primary endpoint is objective response rate (ORR), with multiple secondary endpoints."
The objective response rate (ORR) is the percentage of patients in a clinical trial whose tumors measurably shrink or disappear according to preset rules. Investors use it as a quick, objective signal of a drug’s ability to produce a clear treatment effect—like counting how many plants visibly respond after applying a new fertilizer—and higher ORR can improve odds of regulatory approval, commercial success, and company valuation.
clear cell gynecologic cancer medical
"patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC)"
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): April 8, 2026
(Exact Name of Registrant as Specified in Charter)
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) | |||||||||||||||
| (Address of Principal Executive Offices) | (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:
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered | ||||||
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):
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 8.01 | Other Events. | ||||||||||||||||
On April 8, 2026, MacroGenics, Inc. (the “Company”) issued a press release announcing that the U.S. Food and Drug Administration has removed the partial clinical hold on the Company’s 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.
| Item 9.01 | Financial Statements and Exhibits | |||||||||||||
(d) Exhibits. | |||||||||||||||||
| Exhibit Number | Description of Exhibit | ||||||||||||||||
99.1 | Press Release dated April 8, 2026 | ||||||||||||||||
| 104 | Cover Page Interactive Data (embedded within the Inline XBRL document) | ||||||||||||||||
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.
Date: April 8, 2026 | MACROGENICS, INC. | |||||||||||||||||||||||||
By: /s/ Jeffrey Peters Jeffrey Peters Senior Vice President and General Counsel | ||||||||||||||||||||||||||
Exhibit 99.1
FDA Removes Partial Clinical Hold on MacroGenics’ LINNET Study
•Plan to resume enrollment in clinical study of lorigerlimab in gynecologic cancers
•On track to provide mid-2026 program update
ROCKVILLE, MD., April 8, 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 removed the partial clinical hold on the Company’s Phase 2 LINNET study of lorigerlimab, an investigational, bispecific DART® molecule that targets PD-1 and CTLA-4. During the partial clinical hold, previously enrolled study participants were allowed to continue to receive study drug. Going forward, new participants will be enrolled under a revised protocol that includes additional risk-mitigation measures for potential hematologic and cardiac toxicities.
"We are grateful for the productive interaction with the reviewers at the FDA’s Office of Oncologic Diseases, as well as the diligent efforts of the MacroGenics team to provide a rapid and comprehensive response to the FDA," said Eric Risser, President and Chief Executive Officer of MacroGenics. “With the partial clinical hold lifted, we intend to resume enrollment of new study participants in the ongoing LINNET study and we remain on track to provide a mid-year clinical update on the program.”
About the LINNET Study
The LINNET study is evaluating single-agent lorigerlimab, a bispecific DART® molecule that targets PD-1 and CTLA-4, in up to approximately 60 eligible study participants. These study participants comprise patients with either platinum-resistant ovarian cancer (PROC) or clear cell gynecologic cancer (CCGC) who have received one or more prior lines of therapy. The primary endpoint is objective response rate (ORR), with multiple secondary endpoints. To date, 41 study participants have been dosed in the LINNET study and over 300 study participants have been dosed across all previous lorigerlimab Phase 1 and Phase 2 clinical studies.
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 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
Exhibit 99.1
more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART 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: 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
1-301-251-5172
info@macrogenics.com
Argot Partners
1-212-600-1902
macrogenics@argotpartners.com
FAQ
What did the FDA decision change for MacroGenics (MGNX)?
The FDA removed a partial clinical hold on MacroGenics’ Phase 2 LINNET study of lorigerlimab. Previously enrolled patients could remain on treatment, but now new participants can again be enrolled under a revised protocol with additional safety measures for blood and heart-related toxicities.
What is MacroGenics’ LINNET study evaluating lorigerlimab?
The LINNET study tests single-agent lorigerlimab, a bispecific DART molecule targeting PD-1 and CTLA-4, in gynecologic cancers. It plans to enroll up to about 60 patients with platinum-resistant ovarian cancer or clear cell gynecologic cancer who have received at least one prior therapy line.
How many patients have received lorigerlimab in the LINNET trial so far?
To date, 41 participants have been dosed in the Phase 2 LINNET study of lorigerlimab. In addition, over 300 participants have been treated with lorigerlimab across all Phase 1 and Phase 2 clinical studies, providing a broader safety and activity experience for this investigational antibody.
When will MacroGenics (MGNX) provide an update on lorigerlimab?
MacroGenics expects to provide a clinical program update on lorigerlimab around mid-2026. That update is planned to cover new data from the ongoing Phase 2 LINNET study in gynecologic cancers, following resumption of enrollment under the revised, FDA-cleared trial protocol.
What safety changes were made to the LINNET protocol after the partial hold?
The revised LINNET protocol adds extra risk-mitigation steps for potential hematologic and cardiac toxicities. These changes were part of MacroGenics’ response that led the FDA to lift the partial clinical hold, and will govern how new gynecologic cancer patients are treated in the trial.
What type of drug is lorigerlimab in MacroGenics’ pipeline?
Lorigerlimab is an investigational bispecific DART antibody that targets immune checkpoints PD-1 and CTLA-4. MacroGenics is developing it for cancer treatment, including in the Phase 2 LINNET study for platinum-resistant ovarian and clear cell gynecologic cancers in patients previously treated with other therapies.