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NEW YORK - Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a biopharmaceutical company with a strong financial position and current ratio of 4.16, has initiated a Phase 1 clinical trial for a novel radioimmunotherapy treatment targeting non-Hodgkin Lymphoma (NHL). The first patient has received the initial protein and imaging doses as part of the trial aimed at evaluating the safety and efficacy of the company’s Self-Assembly and Disassembly (SADA) Pre-targeted Radioimmunotherapy (PRIT) platform. According to InvestingPro data, the company maintains more cash than debt on its balance sheet, providing financial flexibility for its clinical development programs.
The trial, known as Trial 1201, is an open-label, dose-escalation study conducted across multiple centers. It focuses on the CD38-SADA: 177Lu-DOTA Drug Complex, which employs a two-step method to deliver targeted radiation to lymphoma cells while sparing normal tissues. The first step involves administering a CD38-SADA protein that binds to lymphoma cells. This is followed by a radioactive payload that selectively targets these cells. Despite the stock’s 72% decline over the past year, InvestingPro analysis suggests the company is currently undervalued, with 8 additional ProTips available for subscribers.
Part A of the trial will determine the optimal dose and timing for administering the CD38-SADA protein and the 177Lu-DOTA payload. The primary endpoints include assessing tumor imaging and monitoring for dose-limiting toxicities.
Dr. Norman LaFrance, Chief Development and Medical Officer at Y-mAbs, expressed optimism about the potential of this approach to improve outcomes for patients with relapsed or refractory NHL, a group that faces limited treatment options.
The SADA PRIT platform’s modular design has also facilitated the development of other bispecific fusion proteins, including GD2-SADA, which is currently in clinical trials for GD2-expressing tumors.
The technology behind SADA was developed at Memorial Sloan Kettering (MSK) by Dr. Nai-Kong Cheung, who holds intellectual property rights. MSK has licensed the technology exclusively to Y-mAbs, which has financial interests in its success.
Y-mAbs Therapeutics is known for its focus on developing innovative cancer treatments, including its FDA-approved anti-GD2 therapy DANYELZA® for high-risk neuroblastoma.
This news is based on a press release statement from Y-mAbs Therapeutics, Inc.
In other recent news, Y-mAbs Therapeutics has been the subject of several analyst updates and financial developments. The company announced an Equity Distribution Agreement with Oppenheimer & Co. Inc., allowing for the potential sale of up to $35 million in common stock. This agreement provides Y-mAbs Therapeutics with flexibility in financing its operations. Meanwhile, BofA Securities downgraded Y-mAbs Therapeutics from Neutral to Underperform, citing challenges such as the underperformance of Danyelza and potential financial strains, and reduced the price target to $3.00. In contrast, Jones Trading maintained a Buy rating but lowered its price target to $18.00, reflecting revised revenue expectations for 2025. Morgan Stanley also revised its price target down to $7.00 while keeping an Underweight rating, noting ongoing market challenges for Danyelza. Cantor Fitzgerald adjusted its price target to $19.00 from $20.00, maintaining an Overweight rating, following Y-mAbs Therapeutics’ mixed 2025 financial guidance. These developments highlight a range of analyst perspectives on Y-mAbs Therapeutics amid evolving financial and market conditions.
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