Genmab A/S (NASDAQ:GMAB) executives outlined a slate of late-stage clinical catalysts expected in 2026, highlighting multiple potentially registrational readouts across three key programs: EPKINLY, Rina-S and petosemtamab. Speaking at a Barclays fireside chat hosted by analyst James Gordon, Chief Financial Officer Anthony Pagano and Chief Commercial Officer Brad Bailey said the company views 2026 as a “very important year” for its late-stage pipeline, with the possibility of label expansions for EPKINLY and first potential registrational datasets that could support launches in 2027 for both Rina-S and petosemtamab.
Three late-stage programs highlighted for 2026
Pagano said all three brands have FDA Breakthrough Therapy Designation and that each had “meaningful data” in 2025 that increased Genmab’s conviction. He added that each program is expected to generate at least one potentially registrational readout in 2026. For EPKINLY, Genmab is focused on potential line extensions into earlier diffuse large B-cell lymphoma (DLBCL) treatment. For Rina-S and petosemtamab, management pointed to the potential for first registrational data that could support launches in 2027.
EPKINLY: focus on PFS endpoints and earlier-line expansion
Pagano said Genmab’s confidence in the upcoming 2026 EPKINLY readouts remains “very high and unchanged,” citing the broader dataset in combinations, including phase II data with EPKINLY plus R-CHOP in frontline DLBCL and EPKINLY plus lenalidomide in second-line-plus DLBCL. Bailey added that key opinion leader feedback was positive on the monotherapy PFS result and referenced what he described as “unprecedented” data supporting a second-line follicular lymphoma (FL) approval in combination, which Genmab said was secured in Q4 2025.
For the trials expected to read out in 2026, Pagano said the primary endpoint for each is PFS and that this endpoint has been agreed with regulators, while acknowledging that regulators assess the “totality of the data.” Genmab expects the second-line DLBCL trial to read out in the first half of 2026. The frontline EPCORE trial (EPKINLY plus R-CHOP) is event-driven, and management reiterated expectations for 2026 timing without commenting on whether any interim analysis has occurred.
On commercial implications, Bailey said the company has consistently viewed EPKINLY’s value as increasing as it moves into earlier lines of therapy. He said earlier-line use could shift administration more into community settings and expand the addressable population substantially versus today. When asked to size the opportunity, Bailey said the frontline setting represents “about half of the value of the brand.” Pagano and Bailey also emphasized operational momentum in expanding beyond large academic centers, with Bailey describing increased ordering across multiple sites within key accounts, suggesting broader adoption closer to where patients live.
Rina-S: registrational Phase II readout expected in H2 2026
Turning to Rina-S, which management described as a folate receptor alpha–targeting antibody-drug conjugate (ADC), Genmab expects a second-line-plus platinum-resistant ovarian cancer (PROC) readout from the RAINFOL-01 study in the second half of 2026. Pagano said Genmab has been encouraged by prior data in PROC, citing “robust efficacy” in response rate and duration of response “regardless of expression level” of the target. He also referenced data in second-line-plus endometrial cancer, noting lower expression levels in that setting while still observing efficacy signals.
Pagano said Genmab has “a lot of confidence” heading into the potentially registrational phase II readout and characterized Rina-S as a “step change” for gynecologic oncology treatment. He added that a companion phase III trial in PROC is fully recruited, and that Genmab is pursuing a similar approach in endometrial cancer with a phase II intended to accelerate time to market alongside a companion phase III program that is “well underway.”
Asked about the importance of subgroup analyses by folate expression level, Pagano said Genmab has not decided what top-line disclosure will look like but suggested initial reporting will focus on top-line results rather than detailed subgroup cuts, while acknowledging both phase II and phase III programs include analyses that may be post hoc or, in some cases, prespecified.
On competition in folate receptor–targeting ADCs, Pagano outlined a framework for evaluating differentiation: product profile (best-in-class potential), speed to market (first-in-class potential), and breadth of the clinical development plan (broadest-in-class potential). He said Genmab believes Rina-S “checks all of those boxes,” pointing to the company’s cross-indication dataset, expected pivotal readout timing in H2 2026, a fully recruited PROC phase III, and additional phase III development including a trial in platinum-sensitive ovarian cancer.
Petosemtamab: Phase III head and neck readouts targeted for H2 2026
For petosemtamab, an EGFR and LGR5 bispecific, Pagano said Genmab expects one or both ongoing phase III trials in head and neck cancer to read out in the second half of 2026. The trials include a frontline study of petosemtamab plus pembrolizumab and a second-line-plus study.
Pagano pointed to data presented at ASCO in 2025 that he said increased conviction, citing an overall response rate (ORR) of about 63% for the combination in the frontline setting, compared with approximately 19% for pembrolizumab monotherapy, as well as 12-month overall survival of about 79% versus historical pembrolizumab controls. He also highlighted what he described as rapid responses, with most responders showing response at the first scan. Pagano said Genmab plans to expand earlier, including starting a phase III in locally advanced head and neck cancer by the end of 2026.
Asked whether efficacy could dilute moving into phase III, Pagano said he would not predict outcomes but that Genmab is not expecting dilution based on the existing dataset. He described petosemtamab as a “best in class” next-generation EGFR-based bispecific.
Commercial buildout and long-term growth outlook
Bailey said Genmab has been building commercial capabilities through partnered launches for EPKINLY and TIVDAK, stating that in the U.S. and Japan the company has established full commercial operations including sales booking, market access, and pricing and reimbursement. He also said Genmab is building its European business following the acquisition of TIVDAK market authorization ownership rights from Pfizer for the U.S. and the world outside China, and cited a recent launch in Germany with additional planned expansion to the U.K., France, Italy and Spain. Bailey said Genmab intends to go to market independently in select key markets and use distributors or partners in others, while saying the company feels confident in its stated guidance on operating expenses.
On financial outlook, Pagano reiterated peak-year sales estimates discussed for the three highlighted brands:
- EPKINLY: $3 billion+ peak-year sales estimate
- Rina-S: $2 billion+ peak-year sales estimate
- Petosemtamab: “multi-billion” peak-year sales estimate
Pagano said those estimates are underpinned largely by “known clinical development plans,” particularly for EPKINLY and Rina-S, with potential expansion opportunities for Rina-S and petosemtamab under early proof-of-concept evaluation. He also pointed to Genmab’s research and discovery engine, saying he expects an internal program to progress from early- to late-stage development in the 2027–2029 timeframe, without specifying an asset. Addressing the eventual loss of DARZALEX royalties, Pagano said Genmab’s remaining royalty portfolio has “nice growth prospects” through that loss, and he characterized the company’s overall growth prospects—particularly entering the 2030s—as “very strong.”
About Genmab A/S (NASDAQ:GMAB)
Genmab A/S is a Denmark-based biotechnology company specializing in the discovery and development of antibody therapeutics for the treatment of cancer. Since its founding in 1999 and with headquarters in Copenhagen, Genmab has built a robust research platform focused on harnessing novel antibody engineering technologies to create next-generation therapies. The company’s work centers on identifying targets in hematologic malignancies and solid tumors, advancing its proprietary molecules from early discovery through clinical development.
Genmab’s portfolio includes products developed in collaboration with leading global pharmaceutical partners.
