Welcome to our dedicated page for Genmab news (Ticker: GMAB), a resource for investors and traders seeking the latest updates and insights on Genmab stock.
Genmab A/S develops antibody medicines for cancer and other serious diseases through therapeutic formats that include bispecific antibodies, antibody-drug conjugates, immune-modulating antibodies and other next-generation modalities. Company news commonly centers on clinical data, regulatory interactions and portfolio decisions for programs such as EPKINLY®/epcoritamab, rinatabart sesutecan (Rina-S®) and petosemtamab.
Recurring updates also cover collaborations and commercialization economics tied to antibody products, including DARZALEX® royalties under the Johnson & Johnson license, EPKINLY development with AbbVie, research partnerships, and capital or shareholder announcements. Genmab’s disclosures frequently connect pipeline progress with hematologic malignancies, solid tumors and the company’s broader antibody-technology strategy.
Genmab (Nasdaq: GMAB) reported updated Phase 1b/2 EPCORE CLL-1 data for epcoritamab in Richter transformation (RT) on Dec 8, 2025. Arm 2A (monotherapy, n=42, median follow-up 22.9 months) showed first-line ORR 57% and CR 52% with median OS 27.5 months and PFS 8.5 months; later-line ORR was 38% (CR 29%). Arm 2B (epcoritamab + lenalidomide, n=11, FU 16.7 months) reported ORR 82%, CR 73% and median PFS 5.7 months. Arm 2C (epcoritamab + R-CHOP, n=30, FU 13.6 months) showed ORR 77%, CR 63% and median PFS 16.0 months. Safety included high rates of CRS and several treatment-related Grade 5 events across arms.
Genmab (Nasdaq: GMAB) reported pivotal Phase 3 EPCORE FL-1 results showing fixed-duration EPKINLY (epcoritamab-bysp) + rituximab and lenalidomide (R2) significantly reduced disease progression or death versus R2 alone (HR 0.21, 79% risk reduction; 95% CI: 0.14–0.31; p<0.0001) in relapsed/refractory follicular lymphoma.
Key efficacy: ORR 95% vs 79% (p<0.0001); CR 83% vs 50%; 12-month DOR 89% vs 49%. Safety: Grade 3–4 TEAEs 90.1% vs 67.6%, with higher neutropenia (68.7% vs 42.0%) and infections (33.3% vs 15.1%). In November 2025 the FDA approved EPKINLY+R2 for R/R FL after ≥1 prior systemic therapy.
Genmab (Nasdaq: GMAB) reported updated EPCORE trial results showing fixed-duration epcoritamab produced high response rates in first-line DLBCL and FL and encouraging monotherapy activity in elderly DLBCL patients.
Key highlights: EPCORE NHL-2 Arm 1 ORR 98%/CR 85% (median follow-up 44.2 months); Arm 8 ORR 93%/CR 86% at two years (n=28); Arm 3 three-year OS 96% in FL; DLBCL-3 monotherapy ORR 73%/CR 62% with 54% progression-free at one year. Safety consistent with prior reports; infections, CRS, and some Grade 5 events observed.
Genmab (Nasdaq: GMAB) announced on November 18, 2025 that the FDA approved EPKINLY (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) for adult patients with relapsed or refractory follicular lymphoma (R/R FL).
The approval follows Phase 3 EPCORE FL-1 results showing a 79% reduction in risk of progression or death (HR 0.21, 95% CI: 0.13-0.33, p<0.0001), median PFS not reached versus 11.2 months for R2, overall response rate 89%, and complete response rate 74% with EPKINLY + R2.
EPKINLY + R2 is the first FDA-approved bispecific-based therapy in the second-line FL setting; safety includes a Boxed Warning for serious or fatal CRS and ICANS, with CRS occurring in 24% of patients.
Genmab (Nasdaq: GMAB) will present more than 20 abstracts, including seven oral presentations, on epcoritamab at the 67th ASH Annual Meeting, December 6-9, 2025.
Highlights include primary Phase 3 EPCORE FL-1 results of epcoritamab plus rituximab and lenalidomide (R2) in relapsed or refractory follicular lymphoma, multiple oral sessions on first- and second-line use in follicular lymphoma and first-line use in diffuse large B-cell lymphoma (DLBCL), and long-term durability data (2–4+ year remissions) across trials. Genmab will host a virtual R&D Update and ASH data review on December 11, 2025.
Genmab (Nasdaq: GMAB) reported updated Phase 1/2 RAINFOL-01 cohort B2 data for investigational rinatabart sesutecan (Rina-S) in advanced endometrial cancer.
At a median one-year follow-up, Rina-S 100 mg/m2 Q3W produced a 50.0% confirmed ORR including two complete responses; 63.6% of responders remain on treatment. Rina-S 120 mg/m2 showed a 44.1% ORR with one CR. Patients had a median of three prior lines. Grade ≥3 serious TEAEs occurred in 36.4% (100 mg/m2) and 52.4% (120 mg/m2). No ocular toxicity, neuropathy, or ILD signals reported. The U.S. FDA granted Breakthrough Therapy Designation and a Phase 3 trial in endometrial cancer is underway.
Genmab (Nasdaq: GMAB) has announced its plans to acquire Merus (Nasdaq: MRUS) in an all-cash transaction valued at approximately USD 8.0 billion, or USD 97.00 per share. The acquisition represents a 41% premium over Merus' closing price on September 26, 2025.
The strategic acquisition brings petosemtamab, a late-stage oncology asset with two FDA Breakthrough Therapy Designations for head and neck cancer, into Genmab's portfolio. The Phase 3 asset showed promising Phase 2 data at ASCO 2025, with superior overall response rates and progression-free survival compared to standard care. Genmab expects potential product launch in 2027, with projected annual sales of $1+ billion by 2029.
The transaction will be funded through cash and $5.5 billion in non-convertible debt. Genmab aims to achieve gross leverage below 3x within two years post-closing. The deal is expected to close by early Q1 2026 and become EBITDA accretive by end of 2029.
Genmab (NASDAQ: GMAB) announced updated results from its Phase 2 EPCORE® NHL-6 trial evaluating epcoritamab monotherapy in relapsed/refractory (R/R) DLBCL patients. The study demonstrated significant success in outpatient treatment, with 92% of patients receiving their first full dose in an outpatient setting.
Key efficacy results showed an overall response rate of 64.3% and complete response rate of 47.6% in patients treated after one prior line of therapy. For patients with two or more prior treatments, the response rates were 60.0% and 38.0% respectively. The safety profile remained consistent with previous studies, with manageable cytokine release syndrome (CRS) occurring in 40.2% of patients, primarily low-grade and resolving within a median of two days.
Genmab (NASDAQ: GMAB) announced that the FDA has granted Breakthrough Therapy Designation (BTD) to rinatabart sesutecan (Rina-S®) for treating adult patients with recurrent or progressive endometrial cancer who have disease progression after platinum-containing regimen and PD-(L)1 therapy.
The designation was supported by results from the Phase 1/2 RAINFOL™-01 trial, where 64 heavily pretreated patients with advanced or recurrent EC were treated with Rina-S. The drug is currently being evaluated as a single-agent treatment in the ongoing Phase 1/2 RAINFOL™-01 trial and will be further studied in a planned Phase 3 trial.
Rina-S is a folate receptor alpha-directed, TOPO1-inhibitor antibody-drug conjugate (ADC) that is also being evaluated in other clinical trials, including the Phase 3 RAINFOL-02 trial in ovarian cancer.
Genmab (NASDAQ: GMAB) announced positive results from its Phase 3 EPCORE® FL-1 trial for epcoritamab combined with rituximab and lenalidomide (R2) in treating relapsed/refractory follicular lymphoma. The trial met both primary endpoints with significant improvements in Overall Response Rate (95.7%, p<0.0001) and Progression-Free Survival (HR 0.21, p<0.0001), reducing disease progression risk by 79%.
The FDA has accepted a priority review for the supplemental Biologics License Application (sBLA) with a target action date of November 30, 2025. If approved, this combination would become the first bispecific antibody regimen available as a second-line treatment for R/R FL patients. The safety profile aligned with known individual regimens with no new safety signals observed.