Genmab A/S (GMAB) PT Raised to $47 at BTIG

BTIG analyst Kaveri Pohlman raised the price target on Genmab A/S (NASDAQ: GMAB) to $47.00 (from $46.00) while maintaining a Buy rating.

The analyst comments "The FDA has granted accelerated approval to Epkinly (epcoritamab-bysp) for the treatment of adult patients with 3L+ FL (after two or more lines of systemic therapy). This grants Epkinly approval for a second indication in just over a year and marks it as the first subcutaneously administered T-cell engaging bispecific antibody approved in the U.S. for r/r FL. As the second most common form of NHL, FL represents 20-30% of all NHL cases. Our model estimates an addressable population of ~5,000 patients per year. As a result of its U.S. approval, we have increased our PoS to 100% (from 80%, peak penetration = 25% in 2029) which brings our PT to $47 (from $46). The approval was based on the response rate from the FL dose expansion cohort of the P1/2 EPCORE NHL-1 clinical trial. The results (detailed below) demonstrated promising outcomes, including an ORR of 82% and a CRR of 63% (MRDnegativity rate = 67%), underscoring Epkinly's potential to provide durable responses for patients facing limited therapeutic options post-relapse. For reference, there are currently two other bispecifics that are approved or in late stages of development for FL – mosunetuzumab (Lunsumio, approved in December 2022) and odronextamab. Odronextamab previously had a PDUFA date of 03/31/24 but received CRLs related to the enrollment status of confirmatory trials (there were no issues regarding efficacy or safety, trial design, labeling, or manufacturing). Overall, Epkinly's response rates are comparable to the other two agents and the data suggest that it will achieve a similar median PFS of >20 months. We anticipate Epkinly to be used initially in the post-Lunsumio setting and offer an advantage over odronextamab (assuming it gets approved) due to its subcutaneous administration. As a reminder, Genmab is running an additional FL expansion cohort focused on Cycle 1 optimization to further reduce CRS."

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