FDA Removes Partial Clinical Hold on MacroGenics’ LINNET Study
Rhea-AI Summary
MacroGenics (NASDAQ: MGNX) announced the FDA has removed a partial clinical hold on its Phase 2 LINNET study of lorigerlimab, a bispecific DART molecule targeting PD-1 and CTLA-4.
The company plans to resume enrollment under a revised protocol with additional risk-mitigation measures for hematologic and cardiac toxicities and remains on track to provide a mid-2026 clinical update.
AI-generated analysis. Not financial advice.
Positive
- FDA removed partial clinical hold on Phase 2 LINNET
- Company intends to resume enrollment of new participants
- On track to provide a mid-2026 clinical update
Negative
- Partial hold reflected safety concerns requiring protocol changes
- Revised protocol adds measures for hematologic and cardiac toxicities
News Market Reaction – MGNX
On the day this news was published, MGNX declined 0.29%, reflecting a mild negative market reaction. Argus tracked a trough of -14.2% from its starting point during tracking. Our momentum scanner triggered 2 alerts that day, indicating moderate trading interest and price volatility. This price movement removed approximately $638K from the company's valuation, bringing the market cap to $219.27M at that time.
Data tracked by StockTitan Argus on the day of publication.
Market Reality Check
Peers on Argus
MGNX is up 5.35% with scanner-flagged peers ATOS and TCRX also moving up (7.88% and 1.89%). Sector summary notes 2 peers rising, suggesting broader biotech momentum alongside today’s company-specific FDA update.
Historical Context
| Date | Event | Sentiment | Move | Catalyst |
|---|---|---|---|---|
| Mar 09 | Full-year earnings | Positive | +45.3% | 2025 results, cash of $189.9M, and multiple 2026 data milestones highlighted. |
| Feb 26 | Investor conferences | Neutral | +0.5% | Announcement of March 2026 investor conference participation and webcasts. |
| Feb 23 | Clinical hold announced | Negative | -1.1% | FDA imposed partial clinical hold on LINNET after serious safety events. |
| Nov 25 | Conference participation | Neutral | +2.1% | CEO fireside chat at Evercore Healthcare Conference with webcast access. |
| Nov 12 | Quarterly earnings | Positive | +8.8% | Q3 2025 results, extended cash runway and continued ADC and LINNET programs. |
MGNX has often reacted positively to operational and earnings updates, while safety-related setbacks like the LINNET partial hold saw only modest downside.
Over the past several months, MacroGenics has highlighted cash runway into late 2027, multiple ADC milestones in 2026, and strong revenue such as $149.5M for 2025. Earnings and pipeline updates on Nov 12, 2025 and Mar 9, 2026 triggered notable gains, while conference participation headlines had minor impact. The February partial clinical hold on LINNET produced only a small decline, and today’s removal of that hold directly follows that safety setback.
Market Pulse Summary
This announcement reports FDA removal of the partial clinical hold on the Phase 2 LINNET study of lorigerlimab, allowing enrollment to resume under a revised safety‑focused protocol. It follows February’s hold tied to serious hematologic and cardiac events. Historically, MacroGenics has emphasized a cash runway into late 2027 and multiple 2026 data catalysts. Investors may watch upcoming LINNET updates around mid‑2026 and broader ADC data readouts for further validation.
Key Terms
partial clinical hold regulatory
phase 2 medical
pd-1 medical
ctla-4 medical
hematologic medical
cardiac toxicities medical
AI-generated analysis. Not financial advice.
• Plan to resume enrollment in clinical study of lorigerlimab in gynecologic cancers
• On track to provide mid-2026 program update
ROCKVILLE, MD, April 08, 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 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