On Thursday, H.C. Wainwright maintained a Buy rating on Genmab A/S (NASDAQ:GMAB) with an unchanged stock price target of $50.00 following the FDA approval of EPKINKLY for the treatment of relapsed or refractory follicular lymphoma. The endorsement from the U.S. Food and Drug Administration is based on favorable results from the Phase 1/2 EPCORE NHL-1 trial.
Genmab, in partnership with AbbVie (NYSE:ABBV), received approval for their CD20xCD3 bispecific antibody, EPKINKLY (epcoritamab), for use in patients who have not responded to or have relapsed following previous treatments. The clinical trial data demonstrated an overall response rate (ORR) of 82%, with a complete response (CR) rate of 60%, showcasing the drug's efficacy across various lines of treatment.
The median progression-free survival (mPFS) recorded in the trial was 15.4 months, while the median duration of response (mDOR), duration of complete response, and median overall survival (mOS) have not yet been reached. The safety profile of EPKINKLY was also noted as favorable, with only 2% of patients experiencing a Grade 3 or higher cytokine release syndrome (CRS) event.
In light of the FDA's decision, H.C. Wainwright has increased the probability of approval for EPKINKLY in the relapsed or refractory follicular lymphoma indication from 65% to 100%. Despite this significant regulatory milestone, the firm has decided to maintain its price target for Genmab at $50.00 over the next 12 months.
The analyst's decision to reiterate the Buy rating and price target reflects confidence in the drug's market potential following the successful FDA approval. This development represents a critical step forward for Genmab and AbbVie in providing a new treatment option for patients with this challenging form of lymphoma.
In other recent news, Genmab A/S has been making significant strides in its operations and strategic initiatives. The company reported robust first-quarter results in 2024, with substantial revenue growth driven by strong sales of DARZALEX and KESIMPTA.
Genmab also completed a $1.8 billion acquisition of ProfoundBio, Inc., acquiring global rights to three clinical-stage candidates and novel ADC technology platforms. This move is expected to bolster Genmab's capabilities in antibody-drug conjugates and fortify its clinical pipeline.
Moreover, the U.S. Food and Drug Administration granted accelerated approval for Genmab's Epkinly for the treatment of adult patients with third-line or higher follicular lymphoma. This approval has led to BTIG raising its price target for Genmab from $46.00 to $47.00, while maintaining a Buy rating on the stock.
In addition, Genmab's drug Acasun, used in the treatment of PD-1 progressed lung cancer, has been highlighted by Truist Securities as a potential $2 billion revenue opportunity, leading to a stock upgrade.
Simultaneously, Genmab has been actively executing its share buyback program and issued restricted stock units and warrants to its employees, aligning the interests of employees with those of shareholders. These are the recent developments at Genmab A/S.
InvestingPro Insights
Following the positive outlook from H.C. Wainwright on Genmab A/S (NASDAQ:GMAB) and the FDA approval of EPKINKLY, the latest data from InvestingPro offers additional insights into the company's financial health and market performance.
Genmab holds a strong cash position, with more cash than debt on its balance sheet, which is a reassuring sign for investors considering the company's financial stability. Moreover, the firm's liquid assets exceed its short-term obligations, indicating a robust liquidity position to support ongoing operations and investment opportunities.
Despite trading near its 52-week low, Genmab's stock exhibits low price volatility, which might appeal to investors looking for stability in their biotech investments. Moreover, analysts predict profitability for the company this year, aligning with the positive momentum following the recent FDA approval. Genmab's market capitalization stands at $16.32 billion USD, and the company has experienced a healthy revenue growth of 16% over the last twelve months as of Q1 2024, signaling a steady upward financial trajectory.
For investors seeking more comprehensive analysis, InvestingPro provides additional InvestingPro Tips for Genmab, including insights on valuation metrics such as the P/E ratio, which currently sits at 21.57. To explore these tips and gain a deeper understanding of Genmab's investment potential, readers can use the coupon code PRONEWS24 to get an extra 10% off a yearly or biyearly Pro and Pro+ subscription. With 10 more tips available on InvestingPro, investors can make more informed decisions backed by extensive data and expert analysis.
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