MacroGenics LINNET Study Partially Lifted by FDA
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Apr 08 2026
0mins
Should l Buy MGNX?
MacroGenics announced that the U. S. 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."
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Analyst Views on MGNX
Wall Street analysts forecast MGNX stock price to fall
4 Analyst Rating
1 Buy
3 Hold
0 Sell
Hold
Current: 3.480
Low
2.00
Averages
3.00
High
4.00
Current: 3.480
Low
2.00
Averages
3.00
High
4.00
About MGNX
MacroGenics, Inc. is a biopharmaceutical company focused on discovering, developing, manufacturing and commercializing monoclonal antibody-based therapeutics for the treatment of cancer. The Company generates its pipeline of product candidates primarily from its suite of antibody-based technology platforms, which have applicability across broad therapeutic domains. It is advancing three proprietary product candidates in clinical development: lorigerlimab, a bispecific DART molecule that targets checkpoint inhibitors PD-1 and CTLA-4; MGC026, an ADC that targets B7-H3 and delivers a novel topoisomerase I inhibitor (TOP1i)-based linker-payload, and MGC028, an ADC that targets ADAM9 and delivers a novel TOP1i-based linker-payload. Its other product candidates are MGD024, retifanlimab, enoblituzumab, and vobramitamab duocarmazine. MGD024 is an investigational, next-generation, bispecific CD123 CD3 DART molecule designed to engage CD3 expressed on immune effector cells, such as T cells.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
MGNX Positioned for Growth in Antibody-Drug Conjugate Market
- FDA Lifts Clinical Hold: MGNX announced that the U.S. FDA has lifted the partial clinical hold on its Phase 2 trial of Lorigerlimab, allowing the study to resume enrolling patients with advanced ovarian and gynecologic cancers, which is expected to accelerate clinical progress and patient recruitment.
- Significant Stock Surge: Following a bullish analyst call, MGNX shares surged approximately 10% on Friday, reaching their highest levels since November 2024, indicating strong market confidence in the company's growth potential, with a year-to-date increase of around 133%.
- Analyst Upgrade: B. Riley upgraded MGNX from ‘Neutral’ to ‘Buy’ with a price target of $9, driven by optimistic projections for the Antibody-Drug Conjugate (ADC) market, asserting that MGNX is uniquely positioned in the emerging “ADAM9 TOPO1i ADC” space.
- Shift in Market Sentiment: Retail sentiment for MGNX on Stocktwits shifted from ‘bearish’ to ‘bullish’, with users expressing increased optimism about the stock's valuation, reflecting a growing confidence among investors regarding the company's future prospects.
See More
Macrogenics Shares Rise as FDA Lifts Clinical Hold on Lorigerlimab Trial
- Clinical Hold Lifted: The FDA's removal of the partial clinical hold on Macrogenics' lorigerlimab mid-stage trial allows the company to begin enrolling new patients under a revised protocol, which is expected to significantly accelerate research progress and enhance market confidence.
- Enhanced Safety Measures: The new protocol includes additional safety measures targeting potential blood and heart-related side effects, aimed at improving patient safety and reducing risks in future trials, thereby enhancing the company's reputation in the biotech sector.
- Trial Progress Update: Macrogenics plans to provide a program update on the LINNET trial in mid-2026, indicating strong confidence in the long-term prospects of lorigerlimab, which may attract more investor interest in its future performance.
- Positive Market Reaction: Following the FDA's lift of the partial hold, Macrogenics shares rose in premarket trading, reflecting investor optimism about the company's resumption of clinical trials, potentially driving further increases in stock price.
See More
MacroGenics FDA Lifts Partial Hold on LINNET Study
- Clinical Study Progress: The FDA's lifting of the partial hold on MacroGenics' LINNET study of Lorigerlimab allows the company to resume enrollment under a revised protocol, with plans to provide a program update by mid-2026, indicating positive momentum in clinical development.
- Safety Event Management: During the FDA hold, MacroGenics worked closely with the agency to address the recruitment pause caused by Grade 4 and 5 safety events reported in four patients, demonstrating the company's commitment to patient safety and regulatory compliance.
- Financial Performance: Total revenue for 2025 slipped to $149.50 million from $149.96 million in the previous year, while net loss widened to $74.62 million or $1.18 per share, reflecting the high costs and market challenges faced during the clinical trial phase.
- Cash Flow Assurance: As of December 31, 2025, MacroGenics had a cash, cash equivalents, and marketable securities balance of $189.91 million, expected to support operations into late 2027, showcasing the company's robust financial management.
See More
MacroGenics Resumes Lorigerlimab Clinical Study Enrollment
- Clinical Study Resumption: MacroGenics announced that the FDA has lifted the partial clinical hold on lorigerlimab, allowing new participants to enroll under a revised protocol, thereby accelerating research into treatments for ovarian and gynecologic cancers.
- Participant Status: The LINNET study has dosed 41 patients to date and plans to evaluate the drug's efficacy in approximately 60 eligible participants, demonstrating the company's ongoing commitment and investment in cancer treatment.
- Risk Mitigation Measures: The new protocol includes additional risk mitigation measures for potential hematologic and cardiac toxicities, aimed at enhancing patient safety and increasing the feasibility of clinical trials, thus boosting the company's competitiveness in the biopharmaceutical industry.
- Future Outlook: MacroGenics expects to provide a mid-2026 clinical update on the program, indicating confidence in future clinical data and market potential, further solidifying its position in the innovative antibody therapeutics space.
See More
MacroGenics Stock Surpasses Analyst Target Price
- Price Target Breakthrough: MacroGenics, Inc (MGNX) shares recently rose to $3.43, surpassing the average analyst 12-month target price of $3.40, indicating optimistic market sentiment that may attract more investor interest.
- Diverse Analyst Reactions: Among analysts covered by Zacks, target prices range from $2.00 to $5.00, with a standard deviation of $1.14, highlighting significant divergence in market views on MGNX's future performance, necessitating careful risk assessment by investors.
- Investor Decision Signal: The stock's rise above the target price provides a signal for investors to reassess the company, prompting them to consider whether the current price is merely a stop on the way to higher targets or if it's time to think about taking profits.
- Wisdom of the Market: The average target price reflects the collective wisdom of multiple experts, and investors should pay attention to this data to better understand the overall market sentiment and potential trends for MGNX.
See More
MacroGenics Antibody Drug Progress Expected in 2026
- Clinical Data Expectations: MacroGenics CEO Eric Risser indicated that the company anticipates reporting clinical data for antibody drug MGC026 in mid-2026 and for MGC028 in the second half of 2026, which could provide positive signals for the company's future market performance.
- Trial Application Plans: The company plans to submit a clinical trial application for MGC030 in the third quarter of 2026, further expanding its antibody drug pipeline and demonstrating its strategic positioning in the cancer treatment sector.
- FDA Clinical Hold: Although the company faced a partial clinical hold from the FDA on its study evaluating lorigerlimab, it is actively working with the agency and expects to provide updates in mid-2026, showcasing its ability to navigate regulatory challenges.
- Strong Financial Position: As of the end of 2022, the company reported cash and cash equivalents of $189.9 million, which is expected to support its operations into late 2027, providing a solid financial foundation for future R&D and market expansion.
See More
MGNX Positioned for Growth in Antibody-Drug Conjugate Market
- FDA Lifts Clinical Hold: MGNX announced that the U.S. FDA has lifted the partial clinical hold on its Phase 2 trial of Lorigerlimab, allowing the study to resume enrolling patients with advanced ovarian and gynecologic cancers, which is expected to accelerate clinical progress and patient recruitment.
- Significant Stock Surge: Following a bullish analyst call, MGNX shares surged approximately 10% on Friday, reaching their highest levels since November 2024, indicating strong market confidence in the company's growth potential, with a year-to-date increase of around 133%.
- Analyst Upgrade: B. Riley upgraded MGNX from ‘Neutral’ to ‘Buy’ with a price target of $9, driven by optimistic projections for the Antibody-Drug Conjugate (ADC) market, asserting that MGNX is uniquely positioned in the emerging “ADAM9 TOPO1i ADC” space.
- Shift in Market Sentiment: Retail sentiment for MGNX on Stocktwits shifted from ‘bearish’ to ‘bullish’, with users expressing increased optimism about the stock's valuation, reflecting a growing confidence among investors regarding the company's future prospects.
See More
Macrogenics Shares Rise as FDA Lifts Clinical Hold on Lorigerlimab Trial
- Clinical Hold Lifted: The FDA's removal of the partial clinical hold on Macrogenics' lorigerlimab mid-stage trial allows the company to begin enrolling new patients under a revised protocol, which is expected to significantly accelerate research progress and enhance market confidence.
- Enhanced Safety Measures: The new protocol includes additional safety measures targeting potential blood and heart-related side effects, aimed at improving patient safety and reducing risks in future trials, thereby enhancing the company's reputation in the biotech sector.
- Trial Progress Update: Macrogenics plans to provide a program update on the LINNET trial in mid-2026, indicating strong confidence in the long-term prospects of lorigerlimab, which may attract more investor interest in its future performance.
- Positive Market Reaction: Following the FDA's lift of the partial hold, Macrogenics shares rose in premarket trading, reflecting investor optimism about the company's resumption of clinical trials, potentially driving further increases in stock price.
See More
MacroGenics FDA Lifts Partial Hold on LINNET Study
- Clinical Study Progress: The FDA's lifting of the partial hold on MacroGenics' LINNET study of Lorigerlimab allows the company to resume enrollment under a revised protocol, with plans to provide a program update by mid-2026, indicating positive momentum in clinical development.
- Safety Event Management: During the FDA hold, MacroGenics worked closely with the agency to address the recruitment pause caused by Grade 4 and 5 safety events reported in four patients, demonstrating the company's commitment to patient safety and regulatory compliance.
- Financial Performance: Total revenue for 2025 slipped to $149.50 million from $149.96 million in the previous year, while net loss widened to $74.62 million or $1.18 per share, reflecting the high costs and market challenges faced during the clinical trial phase.
- Cash Flow Assurance: As of December 31, 2025, MacroGenics had a cash, cash equivalents, and marketable securities balance of $189.91 million, expected to support operations into late 2027, showcasing the company's robust financial management.
See More
MacroGenics Resumes Lorigerlimab Clinical Study Enrollment
- Clinical Study Resumption: MacroGenics announced that the FDA has lifted the partial clinical hold on lorigerlimab, allowing new participants to enroll under a revised protocol, thereby accelerating research into treatments for ovarian and gynecologic cancers.
- Participant Status: The LINNET study has dosed 41 patients to date and plans to evaluate the drug's efficacy in approximately 60 eligible participants, demonstrating the company's ongoing commitment and investment in cancer treatment.
- Risk Mitigation Measures: The new protocol includes additional risk mitigation measures for potential hematologic and cardiac toxicities, aimed at enhancing patient safety and increasing the feasibility of clinical trials, thus boosting the company's competitiveness in the biopharmaceutical industry.
- Future Outlook: MacroGenics expects to provide a mid-2026 clinical update on the program, indicating confidence in future clinical data and market potential, further solidifying its position in the innovative antibody therapeutics space.
See More
MacroGenics Stock Surpasses Analyst Target Price
- Price Target Breakthrough: MacroGenics, Inc (MGNX) shares recently rose to $3.43, surpassing the average analyst 12-month target price of $3.40, indicating optimistic market sentiment that may attract more investor interest.
- Diverse Analyst Reactions: Among analysts covered by Zacks, target prices range from $2.00 to $5.00, with a standard deviation of $1.14, highlighting significant divergence in market views on MGNX's future performance, necessitating careful risk assessment by investors.
- Investor Decision Signal: The stock's rise above the target price provides a signal for investors to reassess the company, prompting them to consider whether the current price is merely a stop on the way to higher targets or if it's time to think about taking profits.
- Wisdom of the Market: The average target price reflects the collective wisdom of multiple experts, and investors should pay attention to this data to better understand the overall market sentiment and potential trends for MGNX.
See More
MacroGenics Antibody Drug Progress Expected in 2026
- Clinical Data Expectations: MacroGenics CEO Eric Risser indicated that the company anticipates reporting clinical data for antibody drug MGC026 in mid-2026 and for MGC028 in the second half of 2026, which could provide positive signals for the company's future market performance.
- Trial Application Plans: The company plans to submit a clinical trial application for MGC030 in the third quarter of 2026, further expanding its antibody drug pipeline and demonstrating its strategic positioning in the cancer treatment sector.
- FDA Clinical Hold: Although the company faced a partial clinical hold from the FDA on its study evaluating lorigerlimab, it is actively working with the agency and expects to provide updates in mid-2026, showcasing its ability to navigate regulatory challenges.
- Strong Financial Position: As of the end of 2022, the company reported cash and cash equivalents of $189.9 million, which is expected to support its operations into late 2027, providing a solid financial foundation for future R&D and market expansion.
See More
