Sign in

You're signed outSign in or to get full access.

GENMAB (GMAB)

--

Recent press releases and 8-K filings for GMAB.

Genmab discontinues acasunlimab clinical development
GMAB
New Projects/Investments
Guidance Update
  • Genmab A/S has decided to discontinue the clinical development of acasunlimab following a portfolio review.
  • This decision reflects the company's prioritization of higher-impact opportunities within its late-stage pipeline and an increasingly competitive landscape.
  • Genmab will now concentrate resources on programs such as EPKINLY® (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S®).
  • The company confirmed that this decision does not impact its full-year 2025 financial guidance.
3 days ago
Genmab Discontinues Acausunlimab Clinical Development
GMAB
New Projects/Investments
Guidance Update
  • Genmab announced the discontinuation of clinical development for acasunlimab following a portfolio review.
  • This decision reflects a strategic focus on higher-impact opportunities within its late-stage pipeline, including EPKINLY® (epcoritamab), petosemtamab, and rinatabart sesutecan (Rina-S®), and the evolving competitive landscape.
  • The company confirmed that this discontinuation does not impact Genmab’s full-year 2025 financial guidance.
3 days ago
Genmab Completes Tender Offer for Merus N.V. Shares
GMAB
M&A
New Projects/Investments
Takeover Bid
  • Genmab A/S has completed its tender offer to acquire common shares of Merus N.V. for $97 per common share in cash.
  • As of December 11, 2025, 94.2% of Merus's issued and outstanding common shares were validly tendered.
  • The acquisition adds petosemtamab, a late-stage asset, to Genmab's portfolio, with an anticipated launch in 2027.
  • Genmab expects the transaction to be accretive to EBITDA by the end of 2029, with petosemtamab projected to achieve at least one-billion-dollar annual sales potential by 2029.
  • A subsequent offering period for additional Merus shares at $97.00 per share commenced on December 12, 2025, and will expire on December 29, 2025.
Dec 12, 2025, 12:00 PM
Genmab Completes Tender Offer for Merus N.V.
GMAB
M&A
New Projects/Investments
Guidance Update
  • Genmab has completed its tender offer for Merus N.V., with 94.2% of Merus's common shares tendered at $97 per share in cash.
  • The acquisition adds petosemtamab, a late-stage asset, to Genmab's portfolio, which is expected to launch in 2027 and be accretive to Genmab's EBITDA by the end of 2029.
  • Petosemtamab is projected to achieve at least one-billion-dollar annual sales by 2029, with multi-billion-dollar annual revenue potential thereafter.
  • A subsequent offering period for additional shares at the same price began on December 12, 2025, and will conclude on December 29, 2025.
Dec 12, 2025, 6:36 AM
Genmab Highlights EPKINLY Approvals, Strong Clinical Data, and Future Pipeline Catalysts
GMAB
Product Launch
New Projects/Investments
M&A
  • 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.
Dec 11, 2025, 4:00 PM
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.
Dec 11, 2025, 4:00 PM
Genmab provides 2025 R&D update and 2026 outlook
GMAB
M&A
New Projects/Investments
Product Launch
  • Genmab announced the proposed acquisition of Mirus and the addition of Pathosentomab to its portfolio, expected to close by early Q1 2026, which is anticipated to position the company for sustained growth and accelerate its shift to a 100%-owned model.
  • The company reported compelling data for RINA-S in second-line endometrial cancer, where it received Breakthrough Therapy Designation, and in platinum-resistant ovarian cancer, with three Phase III and two Phase II potentially registrational trials underway by the end of 2025.
  • At the ASH meeting, significant data was presented for EPKINLY (epcoritamab), including the primary analysis of the randomized Phase III EPCORE FL-1 study, which demonstrated a 79% risk reduction in progression or death for epcoritamab plus R-squared in relapsed follicular lymphoma, leading to FDA approval on November 18th.
  • Genmab anticipates 2026 to be a year of important catalysts, with multiple potential registrational datasets for EPCORE, Rina-S, and Pathosentomab, aiming for four Genmab-owned products on the market by 2027.
Dec 11, 2025, 4:00 PM
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.
Dec 8, 2025, 9:30 PM
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.
Dec 4, 2025, 2:45 PM
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).
Dec 4, 2025, 2:45 PM
Fintool

Ask Fintool AI Agent

Get instant answers from SEC filings, earnings calls & more