Company Announcement Genmab to assume sole responsibility for the continued development and potential commercialization of acasunlimab BioNTech has opted not to participate in the further development of the acasunlimab program under the parties' existing collaboration agreement The overall collaboration between the companies to continue unchanged COPENHAGEN, Denmark; August 5, 2024 – Genmab A/S (NASDAQ:GMAB) announced today that it will assume sole responsibility for the continued development and potential ...

The biotechnology industry had a rough first-half 2024 after a decent performance in 2023. The majority of biotech players do not generate enough revenues to fund their operations and are dependent on external funds. A biotech company starts generating revenues following a successful FDA approval and the launch of any drug. Under this circumstance, a high interest rate regime is detrimental to the biotech industry. The primary reason for the industry's weak performance year to date is that the Fed refrained ...

"Many people living with follicular lymphoma that has either relapsed or is refractory to existing therapies experience significant treatment challenges with poor prognosis," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab. "This positive opinion recognizes the unmet need in the European Union for patients whose follicular lymphoma is considered difficult-to-treat and that epcoritamab may represent a new therapeutic option." Positive CHMP opinion based on results from the Phase 1/2 EPCORE® ...

Company Announcement COPENHAGEN, Denmark; June 28, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) has adopted a positive opinion recommending the granting of conditional marketing authorization of epcoritamab (TEPKINLY®), a T-cell engaging bispecific antibody administered subcutaneously, as a monotherapy for the treatment of adult patients with relapsed or refractory (R/R) follicular lymphoma (FL) after two or ...

COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) announces that itsshare buy-back program has been completed on June 26, 2024. The share buy-back program was expected to be completed no later than December 16, 2024. Details of each transaction are included as an appendix to this announcement. The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 ('MAR') and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." ...

Company Announcement Approval based on results from Phase 1/2 EPCORE® NHL-1 study, which demonstrated durable, clinically meaningful treatment responses in patients with challenging-to-treat R/R FL EPKINLY offers an off-the-shelf, T-cell engaging treatment option that enables treatment across practice settings to address high clinical need EPKINLY is the first and only bispecific antibody approved in the U.S. to treat both relapsed or refractory (R/R) follicular lymphoma (FL) and R/R diffuse large B-cell ly ...

Company Announcement COPENHAGEN, Denmark; June 27, 2024 – Genmab A/S (Nasdaq: GMAB) today announced that the U.S. Food and Drug Administration (FDA) has approved EPKINLY® (epcoritamab-bysp) for the treatment of adults with relapsed or refractory (R/R) follicular lymphoma (FL) after two or more lines of systemic therapy. With this approval, EPKINLY is the first and only T-cell engaging bispecific antibody administered subcutaneously approved in the U.S. to treat this patient population. This indication is ap ...

Company Announcement COPENHAGEN, Denmark; May 21, 2024 – Genmab A/S (Nasdaq: GMAB). On March 15, 2024, Genmab announced the initiation of a share buy-back program to repurchase up to DKK 3.5 billion worth of shares. The share buy-back program is expected to be completed no later than December 16, 2024. The following transactions were executed under the program from May 13, 2024 to May 17, 2024: | | Trading Platform | No. of | Average price | Total value (DKK) | | --- | --- | --- | --- | --- | | | | shares | ...

Jan van de Winkel – Chief Executive Officer Anthony Mancini – Chief Operating Officer Anthony Pagano – Chief Financial Officer Tahi Ahmadi – Chief Medical Officer Judith Klimovsky – Chief Development Officer Operator I would now like to hand the conference over to your first speaker today, Jan van de Winkel. Please go ahead. Before we look at our first quarter results, I want to remind you of our consistent track record of success. Our proprietary technologies fuel our robust product pipeline which is both ...

Quarter End Results Forward looking This presentation contains forward looking statements. The words "believe", "expect", "anticipate", "intend" and "plan" and similar expressions identify forward looking statements. All statements other than statements of historical facts included in this presentation, including, without limitation, those regarding our financial position, business strategy, plans and objectives of management for future operations (including development plans and objectives relating to our ...