Genmab A/S (GMAB:NASDAQ) and partner AbbVie plan to file, in H2/22, a biologics license application with the U.S. Food and Drug Administration (FDA) for subcutaneous epcoritamab for relapsed and refractory large B cell lymphoma, reported H.C. Wainwright & Co. analyst Dr. Ram Selvaraju in a July 1 research note.
"We believe that epcoritamab shall ultimately receive FDA approval," Selvaraju added.
This Denmark-headquartered biotech is developing differentiated antibody therapeutics as cancer treatments. One of them, epcoritamab, targeting CD3 and CD20, is being evaluated for non-Hodgkin's lymphoma as well as for large B cell lymphoma, noted Selvaraju.
To support the biologics license application, Genmab and AbbVie will submit data from the EPCORE non-Hodgkin's lymphoma-1 trial, the analyst indicated. In that study, the cohort of patients with large B cell lymphoma showed epcoritamab elicited a high response rate and a low adverse event rate. These favorable results, presented at the recent annual European Hematology Association meeting, are why H.C. Wainwright anticipates "a relatively uneventful FDA review process" and eventual green light for epcoritamab, Selvaraju wrote.
Specifically, he added, epcoritamab, administered to EPCORE's 157-patient large B cell lymphoma group, resulted in a 63% objective response rate, a 39% complete response rate, and 4.4 months of malignant progression-free survival, and a 56.9% 12-month overall survival rate.
In comparison, results of the same metrics for Roche's glofitamab were 51.6%, 39.4%, 4.9 months, and 49.8%, respectively, demonstrated in 155 patients with relapsed or refractory diffuse large B cell lymphoma.
H.C. Wainwright has a Buy rating and a $47 per share 12-month price target on Genmab. In comparison, its stock is currently trading at around $33.07 per share.
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Disclosures for H.C.Wainwright & Co., Genmab A/S, July 1, 2022
H.C. Wainwright & Co, LLC (the “Firm”) is a member of FINRA and SIPC and a registered U.S. Broker-Dealer. I, Raghuram Selvaraju, Ph.D. and Robert Burns , certify that 1) all of the views expressed in this report accurately reflect my personal views about any and all subject securities or issuers discussed; and 2) no part of my compensation was, is, or will be directly or indirectly related to the specific recommendation or views expressed in this research report; and 3) neither myself nor any members of my household is an officer, director or advisory board member of these companies.
None of the research analysts or the research analyst’s household has a financial interest in the securities of Genmab A/S (including, without limitation, any option, right, warrant, future, long or short position).
As of May 31, 2022 neither the Firm nor its affiliates beneficially own 1% or more of any class of common equity securities of Genmab A/S. Neither the research analyst nor the Firm knows or has reason to know of any other material conflict of interest at the time of publication of this research report.
The research analyst principally responsible for preparation of the report does not receive compensation that is based upon any specific investment banking services or transaction but is compensated based on factors including total revenue and profitability of the Firm, a substantial portion of which is derived from investment banking services. The Firm or its affiliates did not receive compensation from Genmab A/S for investment banking services within twelve months before, but will seek compensation from the companies mentioned in this report for investment banking services within three months following publication of the research report. The Firm does not make a market in Genmab A/S as of the date of this research report.
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