MacroGenics, Inc. develops antibody-based therapeutics for cancer, with pipeline work built around monoclonal antibodies, DART and TRIDENT multi-specific molecules, and antibody-drug conjugates. Company news commonly covers clinical and regulatory updates for lorigerlimab, MGC026 and MGC028, including FDA communications tied to study conduct and safety monitoring.
Updates also address financial results, capital-resource commentary, strategic collaborations and licensing economics, including royalty interests tied to ZYNYZ (retifanlimab-dlwr), a PD-1 inhibitor originally developed by MacroGenics and licensed to Incyte.
MacroGenics (MGNX) announced that its management team will participate in two investor conferences in November, with CEO Eric Risser giving fireside chats.
The Stifel 2026 Healthcare Conference chat in New York is November 11 at 10:00 am ET; the 9th Annual Evercore Healthcare Conference chat in Coral Gables is November 30 at 3:00 pm ET. Management will also hold one-on-one meetings at both events. Webcast replays will remain available for 30 days.
MacroGenics (NASDAQ: MGNX) appointed Emil Kuriakose, M.D., and Michael Vasconcelles, M.D., as independent directors, effective October 30, 2026.
Kuriakose most recently served as Chief Medical Officer of Terns Pharmaceuticals, overseeing clinical, regulatory, medical affairs and portfolio strategy. His earlier roles included positions at Calithera Biosciences and Novartis Oncology. Vasconcelles most recently served as Head of Research and Development at Day One Biopharmaceuticals. He previously held leadership positions at ImmunoGen, Flatiron Health, Unum Therapeutics and Takeda Pharmaceuticals, and currently serves as an independent director of Molecular Partners and Kura Oncology. MacroGenics said the appointees bring oncology drug development experience relevant to advancing its pipeline.
MacroGenics (NASDAQ: MGNX) reported interim Phase 2 lorigerlimab results showing a 25% response rate in clear cell gynecologic cancer (CCGC).
At the September 1, 2026 cutoff, confirmed responses occurred in 4 of 16 response-evaluable CCGC patients; disease control was 44% (7/16). All responses remained ongoing. Among 17 safety-evaluable CCGC patients, median progression-free survival was 2.9 months (95% confidence interval, 1.9–6.2), with 33% progression-free at six months.
The LINNET study treated 41 patients at 6 mg/kg every three weeks, including 24 with platinum-resistant ovarian cancer. Grade 3 or higher treatment-related adverse events occurred in 49%, with one Grade 5 (fatal) event in the ovarian cancer cohort. Treatment-related events caused discontinuation in 24% overall and 18% of CCGC patients. MacroGenics is enrolling 20 additional CCGC patients at 3 mg/kg every three weeks and expects updated results in the first half of 2027.
MacroGenics (MGNX) reported interim Phase 1 MGC026 results showing a 27% best overall response rate in heavily pretreated head-and-neck cancer patients. At the September 1, 2026 cutoff, six of 22 response-evaluable patients with recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN) had partial responses: four confirmed and two unconfirmed. Disease control was 64%.
Among 17 evaluable dose-escalation patients receiving at least 6 mg/kg across solid tumors, confirmed response was 29%, with median response duration of 10.2 months. Across 85 treated patients, severe or worse treatment-related adverse events occurred in 51%, and 5% discontinued treatment. No treatment-related discontinuations occurred among 27 SCCHN patients evaluated for safety. MacroGenics plans a front-line MGC026–pembrolizumab cohort in early 2027 for PD-L1-positive SCCHN and expects updated ongoing-study data in mid-2027.
MacroGenics (MGNX) has dosed the first patient in its Phase 1 study of MGC030 in patients with advanced solid tumors. MGC030 is an antibody-drug conjugate, an antibody linked to a drug, directed against an undisclosed target and is the company's third such candidate in active clinical development.
The open-label, multi-center study will assess safety, tolerability, drug behavior in the body, immune responses and preliminary antitumor activity, while exploring associated biomarkers. Dose escalation will enroll up to 54 participants, with potential expansion at selected doses. Eligible patients have relapsed or treatment-resistant solid tumors that cannot be surgically removed, are locally advanced or have spread.
MacroGenics (MGNX) announced that President and CEO Eric Risser will present at the H.C. Wainwright 28th Annual Global Investment Conference on Wednesday, September 16, 2026, at 9:30 a.m. ET.
The live webcast and an archived replay, available for 30 days, can be accessed via the Investor Relations “Events & Presentations” page on the company’s website.
MacroGenics (NASDAQ: MGNX) reported second quarter 2026 revenue of $32.8 million, up from $6.9 million a year earlier, driven mainly by a $24.5 million regulatory milestone from Sanofi related to U.S. approval of TZIELD. Net income was $19.5 million, versus a prior-year net loss of $36.3 million, largely reflecting $89.2 million income from discontinued operations tied to the sale of its GMP manufacturing operations to Bora and a $52.8 million non-cash loss on extinguishment of a ZYNYZ royalty monetization liability.
The July sale of manufacturing operations to Bora generated $119.6 million of cash at closing from a $122.5 million base purchase price, and supports a transition to a fully outsourced model. Together with milestone and option payments from Sanofi, Gilead and Sagard, pro forma cash, cash equivalents and marketable securities reached $327 million, with estimated cash runway through 2028.
Pipeline highlights include MGC026 advancing into Stage 2 in SCCHN and Phase 1 interim ESMO 2026 data, ongoing dose escalation for MGC028, FDA-cleared IND and imminent Phase 1 start for MGC030, continued Phase 2 evaluation of lorigerlimab, and nomination of next-generation TCE candidate MGD032.
MacroGenics (NASDAQ: MGNX) reported that Gilead Sciences has exercised its option to obtain an exclusive license to a preclinical bispecific program under their 2022 collaboration, triggering a $10 million payment to MacroGenics.
The licensed solid-tumor program uses MacroGenics’ TRIDENT® platform and targets two undisclosed antigens. According to MacroGenics, the collaboration covers three programs in total: MGD024, a clinical-stage CD123 × CD3 DART® molecule, plus two preclinical bispecific programs. MacroGenics remains eligible to receive up to approximately $1.6 billion in additional development, regulatory and commercial milestone payments across the collaboration, as well as royalties on potential worldwide net sales from resulting products.
MacroGenics (NASDAQ: MGNX) provided a clinical update on its ongoing Phase 1, first-in-human study of MGC026, a B7-H3–directed antibody-drug conjugate with a topoisomerase I inhibitor payload, in patients with advanced solid tumors. Dose escalation from 1 to 9 mg/kg every three weeks has been completed, and a 7.5 mg/kg q3W dose is being evaluated in four tumor-specific cohorts: recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN), endometrial cancer, melanoma and soft tissue sarcoma.
The SCCHN cohort, using Simon’s two-stage design with a planned 40 patients, achieved its pre-specified Stage 1 response threshold and has moved to Stage 2 enrollment. As of July 8, 2026, 74 patients had been enrolled across dose escalation and cohort expansion. According to MacroGenics, no cases of interstitial lung disease or ocular toxicity had been reported by that date, and evidence of anti-tumor activity had been observed across several indications. Detailed dose escalation and preliminary cohort data will be presented in a poster at the ESMO 2026 Congress in Madrid from October 23-27, alongside a separate Phase 2 poster on lorigerlimab in advanced gynecologic cancers.
MacroGenics (NASDAQ: MGNX) completed the sale of its GMP drug substance manufacturing operations to Bora Pharmaceuticals on July 2, 2026. Bora paid $122.5 million, before fees and adjustments, and assumed responsibility for clinical and commercial manufacturing.
The Rockville manufacturing site, Frederick warehouse, and about 140 employees transferred to Bora. MacroGenics also signed a supply agreement under which Bora will provide process development and drug substance production for MacroGenics’ internal pipeline.