Strong Data Suggests FDA Will Approve New Lymphoma Drug


A green light is expected for the treatment after its developers submitted a biologics license application for it, slated for H2/22, a report by HC Wainwright & Co. noted.

Genmab A/S (GMAB:NASDAQ) and its partner AbbVie plan to file a biologics license application with the U.S. Food and Drug Administration (FDA) in H2/22 for subcutaneous epcoritamab for relapsed and refractory large B-cell lymphoma, HC Wainwright Dr. Ram Selvaraju, an analyst at & Co., reported in a July 1 research note.

“We believe epcoritamab will eventually receive FDA approval,” Selvaraju added.

This Denmark-based biotech develops differentiated therapeutic antibodies as cancer treatments. One of them, epcoritamab, targeting CD3 and CD20, is being evaluated for non-Hodgkin’s lymphoma as well as large B-cell lymphoma, Selvaraju noted.

To support the biologics license application, Genmab and AbbVie will submit data from the EPCORE trial in non-Hodgkin’s lymphoma-1, the analyst said. In this study, the cohort of patients with large B-cell lymphoma showed that epcoritamab caused a high response rate and a low rate of adverse events. These favorable results, presented at the recent annual meeting of the European Hematology Association, explain why HC Wainwright anticipates “a relatively uneventful FDA review process” and eventual green light for epcoritamab, wrote. Selvaraju.

Specifically, he added, epcoritamab, given to EPCORE’s group of 157 large B-cell lymphoma patients, resulted in a 63% objective response rate, a 39% complete response rate. and 4.4 months malignant progression-free survival, and a 56.9% 12 month overall survival rate.

In comparison, the results of the same parameters for Roche’s glofitamab were 51.6%, 39.4%, 4.9 months and 49.8%, respectively, in 155 patients with diffuse large B-cell lymphoma relapsed or refractory.

HC Wainwright has a buy rating and a 12-month price target of $47 per share on Genmab. By comparison, its stock is currently trading at around $33.07 per share.

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Disclosures for HC Wainwright & Co., Genmab A/S, July 1, 2022

HC Wainwright & Co, LLC (the “Company”) is a member of FINRA and SIPC and a registered US broker-dealer. I, Raghuram Selvaraju, Ph.D. and Robert Burns certify that 1) all opinions expressed in this report accurately reflect my personal opinions on all 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 opinions expressed in this research report; and 3) neither I nor any member of my household are officers, directors or members of the advisory board of these companies.

None of the research analysts or the research analyst’s household has any financial interest in the securities of Genmab A/S (including, without limitation, any option, right, mandate, future position, long or short).

As of May 31, 2022, neither the Company nor its affiliates beneficially owned 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 primarily responsible for preparing the report does not receive compensation based on specific investment banking services or transactions, but is compensated based on factors such as total revenue and firm profitability , a substantial portion of which comes from investment banking. services. The company or its affiliates have not received compensation from Genmab A/S for investment banking services in the preceding twelve months, but will seek compensation from the companies mentioned in this report for investment banking services within three months of the publication of the research report. The company does not trade in Genmab A/S as of the date of this research report.

The securities of the company discussed in this report may not be suitable for investors depending on their specific investment objectives and financial situation. Past performance is not indicative of future results. This report is offered for informational purposes only and does not constitute an offer or solicitation to buy or sell any securities mentioned herein in any jurisdiction where this is prohibited.

This research report is not intended to provide tax advice or to be used to provide tax advice to anyone. Electronic versions of HC Wainwright & Co., LLC research reports are made available to all clients simultaneously. No part of this report may be reproduced in any form without the express permission of HC Wainwright & Co., LLC. Additional information available on request.

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Vendors, traders and other professionals of HC Wainwright & Co., LLC and its affiliates may provide oral or written market commentary or trading strategies that reflect opinions contrary to the opinions expressed in this research report. HC Wainwright & Co., LLC and its affiliates, officers, directors and employees, excluding its analysts, will from time to time take long or short positions, act as principal and buy or sell securities or derivatives (including options and warrants) thereof of the covered companies mentioned in this research report.

The information contained herein is based on sources we believe to be reliable, but the accuracy of which we do not guarantee and do not purport to be a complete statement or summary of available company, industry or safety data. discussed in the report. All opinions and estimates included in this report constitute the analyst’s judgment as of the date of this report and are subject to change without notice.

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