MacroGenics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of antibody-based therapeutics for the treatment of cancer. Its product pipeline includes Margetuximab, Flotetuzumab, Retifanlimab, Enoblituzumab, Tebotelimab, MGC018, MGD019, IMGC936, and MGD014 for infectious diseases. The company was founded by Scott E. Koenig, Jeffrey V. Ravetch, LeRoy E. Hood, Ruedi Aebersold, and Alan Aderem on August 14, 2000 and is headquartered in Rockville, MD.
Clinical Trials
51
2 active
Approvals
0
Total approvals
Agencies
0
Regulatory bodies
Founded
N/A
Active, not recruiting
1
2.0%
Completed
27
52.9%
No Longer Available
2
3.9%
Not yet recruiting
1
2.0%
Recruiting
6
11.8%
Terminated
12
23.5%
Withdrawn
2
3.9%
No approval data available
- GSK and Hansoh reported that the B7-H3-targeted antibody-drug conjugate risvutatug rezetecan reduced the risk of death by 54% versus topotecan in relapsed small cell lung cancer. - In the phase III ARTEMIS-008 trial, median overall survival reached 18.5 months with Ris-Rez versus 10.3 months with topotecan after a median 12.2 months of follow-up. - Secondary endpoints favored Ris-Rez, with median progression-free survival of 7.2 versus 3.0 months and objective response rates of 58.3% versus 12.6%. - Grade 3 or higher treatment-related adverse events occurred in 60.9% of Ris-Rez patients versus 78.2% with topotecan, with hematologic toxicities predominating.
- MacroGenics will receive $122.5 million upfront from Bora Pharmaceuticals for the sale of its good manufacturing practice drug substance manufacturing operations. - The transaction includes transfer of FDA-approved facilities in Maryland with 11,000-liter capacity and approximately 140 employees to Bora. - MacroGenics will maintain access to manufacturing capabilities through a supply arrangement while focusing resources on advancing its cancer therapeutic pipeline. - The deal supports Bora's strategy to expand North American biologics operations and establish end-to-end clinical and commercial production capabilities.
- MacroGenics is developing three innovative antibody-drug conjugates (ADCs) targeting B7-H3, ADAM9, and an undisclosed antigen, with initial clinical data expected from MGC026 and MGC028 in 2026. - The company's ADC programs have demonstrated acceptable safety profiles with no interstitial lung disease observations and early evidence of anti-tumor activity by RECIST criteria. - MacroGenics maintains a strong financial position with $189.9 million in cash and securities, providing runway into late 2027 to support clinical development milestones. - Partnership programs with Gilead, Sanofi, and Incyte continue to progress, with MacroGenics eligible for up to $2.47 billion in future milestone payments across all collaborations.
- The FDA has placed a partial clinical hold on MacroGenics' Phase 2 LINNET study of lorigerlimab, a bispecific DART molecule targeting PD-1 and CTLA-4, in gynecologic cancers following severe safety events in four patients. - Safety events included Grade 4 thrombocytopenia in two patients, Grade 4 myocarditis in one patient, and Grade 4 neutropenia with septic shock leading to one death across 41 dosed participants. - Current study participants may continue receiving treatment while no new patients can be enrolled until the FDA lifts the hold, with MacroGenics committed to working with regulators to resolve the safety concerns.
- A 2023 JAMA Internal Medicine study revealed that 21 of 210 new drugs approved by the FDA between 2018 and 2021 failed to meet at least one primary efficacy endpoint in pivotal trials. - High-profile failures include Biogen's Qalsody for ALS, MacroGenics' Margenza for breast cancer, and Sarepta's Vyondys 53 and Amondys 45 for Duchenne muscular dystrophy, yet most remain on the market. - The FDA's reliance on biomarker evidence and surrogate endpoints for accelerated approvals creates regulatory challenges when confirmatory trials fail to demonstrate clinical benefit. - Only seven of 21 approved drugs with failed endpoints were required to conduct confirmatory studies, highlighting inconsistent regulatory oversight.
- MacroGenics discontinued lorigerlimab development in second-line metastatic castration-resistant prostate cancer after interim Phase 2 LORIKEET trial data showed the experimental treatment arm would not meet its primary endpoint of improved radiographic progression-free survival. - The company secured $75 million in non-dilutive partnership payments from Sanofi and Gilead, with Gilead licensing an additional preclinical T-cell engager program for $25 million and Sanofi triggering $50 million in milestone payments following TZIELD approvals in the UK and China. - MacroGenics continues advancing lorigerlimab in gynecologic cancers through the ongoing Phase 2 LINNET study and is progressing three antibody-drug conjugate programs including MGC026, MGC028, and MGC030. - The company extended its cash runway guidance into late 2027, supported by $146.4 million in cash plus the additional $75 million in partnership proceeds expected by year-end 2025.
- MacroGenics appointed Eric Risser as President and CEO effective August 13, 2025, replacing Scott Koenig who led the company for 24 years. - Risser brings nearly 30 years of biotech experience and has generated over $1.6 billion in non-dilutive capital through corporate development efforts since joining MacroGenics in 2009. - The leadership transition comes as MacroGenics focuses on developing innovative monoclonal antibody-based cancer therapeutics, with three FDA-approved products already in its portfolio. - Risser aims to create a more focused and capital-efficient biotechnology company that delivers high-value cancer therapies to patients.
- Specialised Therapeutics has expanded its partnership with Incyte to include axatilimab and retifanlimab for distribution in Australia, New Zealand, and Singapore, with potential expansion to other Asia-Pacific countries. - Axatilimab, a first-in-class CSF-1R-blocking antibody approved by the FDA in August 2024, treats chronic graft-versus-host disease after failure of at least two prior systemic therapies. - Retifanlimab, a PD-1 inhibitor, is approved for treating squamous cell carcinoma of the anal canal and Merkel cell carcinoma, with Australia having the highest global incidence of the latter condition. - Both therapies are expected to undergo regulatory and reimbursement approval submissions in the region during 2025.
- MacroGenics received a $70 million upfront payment from Sagard Healthcare Partners through a royalty purchase agreement for ZYNYZ, a PD-1 inhibitor approved for anal canal carcinoma and Merkel cell carcinoma. - The deal extends MacroGenics' cash runway through the first half of 2027, providing financial stability as the company advances its pipeline of antibody-drug conjugates and bispecific therapeutics. - Under new CEO Eric Risser's leadership, MacroGenics is focusing on advancing key programs including lorigerlimab for prostate cancer, MGC026 and MGC028 ADCs for solid tumors, and preparing MGC030 for clinical trials. - The company reported $176.5 million in cash reserves as of June 30, 2025, with total revenue of $22.2 million in Q2 2025, primarily driven by increased contract manufacturing services.
- Provention Bio received FDA approval for teplizumab (Tzield), marking the first disease-modifying therapy to delay onset of stage 3 type 1 diabetes in at-risk patients aged eight and older. - Clinical trial data showed Tzield delayed progression to stage 3 disease by 25 months compared to placebo, with only 45% of treated patients progressing versus 72% on placebo after 51 months median follow-up. - The approval comes after an initial FDA rejection in July 2021 due to pharmacokinetic concerns, which Provention addressed through resubmission with modified dosing data. - Sanofi has partnered with Provention for US co-promotion, providing $20 million upfront with an additional $35 million equity investment following approval.
