GENMAB (GMAB) Company Report

Genmab's EPKINLY (epcoritamab) recently received FDA approval in combination with R-squared for second-line follicular lymphoma, supported by unprecedented Phase 3 data from the EPCORE FL-1 study demonstrating a 79% risk reduction in progression or death.
The company presented extensive positive clinical data for epcoritamab at ASH across follicular lymphoma and diffuse large B-cell lymphoma, including high response rates and long-term follow-up, positioning it to challenge existing treatment standards.
Genmab expects multiple potential registrational data sets in 2026 for EPCORE, Rina-S, and beta centromere, aiming for four KISO products on the market by 2027, with half being entirely Genmab-owned.
Strategic initiatives include the rapid integration of MARUS post-acquisition and continued investment to evolve into a diversified, fully integrated global biotech leader.

32 minutes ago

Transcript

Genmab Highlights EPKINLY's Expanded Approvals and Future Pipeline Catalysts

GMAB

Product Launch

New Projects/Investments

M&A

EPKINLY (epcoritamab) received FDA approval in combination with R squared for second-line follicular lymphoma, based on unprecedented Phase 3 data from the EPCORE FL-1 study.
The EPCORE FL-1 study demonstrated significant efficacy, showing a 79% risk reduction in progression or death (hazard ratio of 0.21) and an overall response rate of 95% for epcoritamab plus R squared.
Promising data for epcoritamab in Diffuse Large B-cell Lymphoma (DLBCL) frontline settings include overall response rates of 98% and 93% in different patient cohorts, with a Phase 3 trial (EPCORE DLBCL-2) expected to read out in 2026.
Genmab anticipates multiple potential registrational data sets for EPCORE, Rina-S, and beta centromere in 2026, aiming for four KISO products on the market by 2027, with half being entirely Genmab-owned.
The company is strategically positioning epcoritamab as a backbone therapy and prioritizing chemo-free regimens, particularly in follicular lymphoma, due to its versatility and favorable safety profile.

2 hours ago

Transcript

Genmab Announces Positive Epcoritamab Data for Richter Transformation

GMAB

New Projects/Investments

Genmab presented new and updated data from the Phase 1b/2 EPCORE CLL-1 trial for epcoritamab-bysp in patients with Richter transformation (RT) at the 67th Annual Meeting and Exposition of the American Society of Hematology.
In Arm 2A, epcoritamab monotherapy in first-line RT patients (n=21) achieved an overall response rate (ORR) of 57% and a complete response (CR) rate of 52%, with a median overall survival (OS) of 27.5 months.
Combination regimens also demonstrated promising efficacy: epcoritamab with lenalidomide (Arm 2B, n=11) resulted in an ORR of 82% and CR rate of 73%, while epcoritamab with R-CHOP (Arm 2C, n=30) showed an ORR of 77% and CR rate of 63%.
The safety profiles across all three study arms were consistent with the known profiles of each agent, with cytokine release syndrome (CRS) being common but primarily low grade.

3 days ago

Press Release

Genmab Highlights Strong Late-Stage Pipeline and Financial Performance in 2025

GMAB

M&A

Guidance Update

New Projects/Investments

Genmab reported strong financial performance for the first nine months of 2025, with total revenue growth of 21% and recurring revenue growth of 26%.
The company's late-stage pipeline, including Epkinly, RENA-S, and PETO, are anticipated to have meaningful registrational data readouts in 2026 and potential product launches in 2027.
PETO, acquired via the Merus transaction, is projected to exceed $1 billion in sales by 2029, with one or both of its ongoing Phase 3 trials expected to read out in 2026.
Epkinly is targeting a $3 billion peak year sales, with key Phase 3 readouts in 2026 for second-line and front-line DLBCL, the latter representing a significant portion of its total addressable market.
Genmab plans to reduce its gross leverage to below three times within 24 months of the Merus deal close, following the $5.5 billion debt used for the acquisition.

7 days ago

Transcript

Genmab Provides Update on Late-Stage Pipeline, Financial Performance, and Merus Acquisition

GMAB

New Projects/Investments

M&A

Guidance Update

Genmab is advancing three late-stage programs—Epkinly, RENA-S, and PETO—all holding FDA breakthrough therapy designations, with significant registrational data expected in 2026 and potential launches in 2027.
The company reported robust financial performance for the first nine months of 2025, achieving 21% total revenue growth and 26% recurring revenue growth.
Genmab projects substantial peak sales for its key assets, including Epkinly targeting $3 billion, PETO exceeding $1 billion in sales by 2029, and RENA-S targeting $2 billion.
Following the Merus acquisition, which was funded by $5.5 billion in debt, Genmab aims to reduce its gross leverage to below three times within 24 months of the deal close (by 2027).

7 days ago

Transcript

Genmab CFO Discusses Strong 2025 Performance, Key Pipeline Milestones, and Deleveraging Plan

GMAB

Guidance Update

New Projects/Investments

M&A

Genmab reported strong financial performance for the first nine months of 2025, with total revenue growth of 21% and recurring revenue growth of 26%.
The company anticipates significant clinical milestones in 2026, including one or both Phase 3 readouts for PETO and two additional Phase 3 readouts for Epkinly, notably in front-line DLBCL, with potential launches for these and RENA-S in 2027.
Genmab projects PETO to exceed $1 billion in sales by 2029 and RENA-S to achieve $2 billion in peak year sales.
Following the Merus acquisition, funded by $5.5 billion of debt, Genmab plans to reduce its gross leverage to below 3 times within 24 months of the deal close (by 2027).

7 days ago

Transcript

Genmab discusses late-stage pipeline, financial outlook, and Petosemtamab acquisition at Jefferies conference

GMAB

Guidance Update

New Projects/Investments

M&A

Genmab expects 2026 to be an investment year, with a return to meaningful EBITDA growth anticipated in 2027.
The company upgraded its peak year sales guidance for Rina-S to $2 billion, up from over $1 billion, with a launch expected in 2027 and the first Phase II registrational readout in PROC in 2026.
Genmab projects Petosemtamab (Peto), acquired through Merus, to achieve over $1 billion in sales by 2029, with the transaction expected to be highly accretive on the EBITDA line by that year.
Epkinly is positioned as a potential $3 billion+ global brand, with recent positive data and FDA approval for second-line follicular lymphoma, demonstrating a hazard ratio of 0.21.

Nov 19, 2025, 12:00 PM

Transcript

Genmab Discusses Late-Stage Pipeline and Financial Outlook for Acquisitions

GMAB

New Projects/Investments

M&A

Guidance Update

Genmab is prioritizing late-stage programs including Epkinly, Rinatabart sesutecan, Acasunlimab, and Patu Centamab.
The company anticipates 2026 will be an investment year, with a projected return to meaningful EBITDA growth in 2027.
The acquisition of Patu Centamab (via Merus) is expected to be highly accretive by 2029, with sales projected to reach $1 billion or more in that year. Clinical data for Patu Centamab in frontline head and neck cancer shows a 63% overall response rate when combined with Pembrolizumab.
Rinatabart sesutecan's peak year sales guidance has been upgraded to $2 billion, with a launch anticipated in 2027.
Epkinly is performing strongly since its May 2023 launch and is considered a potential $3 billion-plus global brand.

Nov 19, 2025, 12:00 PM

Transcript

Genmab Announces FDA Approval for EPKINLY Combination Therapy in Follicular Lymphoma

GMAB

Product Launch

New Projects/Investments

Genmab A/S announced on November 18, 2025, that its drug EPKINLY® (epcoritamab-bysp) in combination with rituximab and lenalidomide (EPKINLY + R2) received U.S. FDA approval for adult patients with relapsed or refractory (R/R) follicular lymphoma (FL).
This approval is based on the Phase 3 EPCORE® FL-1 study, where EPKINLY + R2 reduced the risk of disease progression or death by 79% compared to standard of care R2, with 89% of patients responding and 74% achieving a complete response.
This marks the third indication for EPKINLY and is the first-ever FDA approval for a bispecific combination therapy in the lymphoma space.
The FDA also converted the accelerated approval of EPKINLY monotherapy for R/R FL into a full approval based on the results from the confirmatory Phase 3 EPCORE FL-1 study.

Nov 18, 2025, 5:10 PM

6-K

Genmab Announces Proposed Debt Offerings and Term Loan Facilities

GMAB

Debt Issuance

M&A

New Projects/Investments

On November 10, 2025, Genmab A/S announced plans to offer $1.5 billion in senior secured notes due 2032 and $1.0 billion in senior unsecured notes due 2033.
The company also launched the syndication of a new $2.0 billion senior secured term loan "B" facility.
These debt offerings and the new term loan facility, along with existing $1.0 billion senior secured term loan "A" and $500 million senior secured revolving credit facilities, are intended to finance the pending acquisition of Merus N.V..