Welcome to our dedicated page for Y-Mabs Therapeutics news (Ticker: YMAB), a resource for investors and traders seeking the latest updates and insights on Y-Mabs Therapeutics stock.
Y-mAbs Therapeutics, Inc. (YMAB) is a commercial-stage biopharmaceutical leader pioneering antibody-based therapies and radioimmunotherapy for pediatric and adult cancers. This page provides investors and medical professionals with comprehensive access to Y-mAbs' official news, including FDA regulatory updates, clinical trial results, and strategic partnership announcements.
As the developer of DANYELZA – an FDA-approved treatment for high-risk neuroblastoma – Y-mAbs demonstrates ongoing innovation through its SADA PRIT platform and bispecific antibody research. Our curated news collection enables stakeholders to track the company's progress in advancing precision oncology treatments while maintaining compliance with rigorous clinical standards.
Key updates include press releases on product commercialization milestones, peer-reviewed study publications, and developments in the company's pipeline targeting GD2-expressing tumors. All content is sourced directly from Y-mAbs Therapeutics and verified financial disclosures to ensure reliability.
Bookmark this page for real-time updates on YMAB's scientific advancements and market-moving developments. Investors can leverage this resource to monitor the company's progress in bringing novel radioimmunotherapies through clinical trials to commercialization.
Y-mAbs Therapeutics (NASDAQ: YMAB) presented a trial in progress poster for their GD2-SADA Pretargeted Radioimmunotherapy (PRIT) at the Advances in Neuroblastoma Research Meeting. The presentation focuses on Trial 1001, a Phase 1 clinical trial evaluating the safety and tolerability of GD2-SADA PRIT with Lutetium 177 DOTA in patients aged 16 and older.
The trial targets patients with recurrent or refractory metastatic GD2-expressing solid tumors, including high-risk neuroblastoma, small cell lung cancer, sarcoma, and melanoma. The company has completed Part A of the trial, which involved dose escalation of GD2-SADA protein to determine optimal safe dosing. Initial data readout is scheduled for May 28th during their virtual Radiopharmaceutical R&D update.
Y-mAbs Therapeutics (NASDAQ: YMAB) has announced a virtual Radiopharmaceutical R&D update scheduled for May 28, 2025, at 8:00 a.m. ET. The 90-minute presentation will cover several key areas including:
- Part A clinical data from the ongoing Phase 1 GD2-SADA clinical trial (Trial 1001), featuring pharmacokinetic and dosimetry data
- Updates on nonclinical optimization studies for the GD2-SADA asset and clinical implementation plans
- The company's Radiopharmaceutical pipeline strategy, including new planned target programs and timelines
The event will be accessible via webcast on Y-mAbs' Investor Relations website and will remain archived for at least 30 days.
Y-mAbs Therapeutics (NASDAQ: YMAB) announced that its drug naxitamab-gqgk (DANYELZA®) has been included in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines as a Category 2A treatment option for high-risk neuroblastoma. The drug, which received FDA accelerated approval in November 2020, is used in combination with GM-CSF for treating relapsed or refractory high-risk neuroblastoma in pediatric patients (1+ years) and adults.
DANYELZA's FDA approval was based on efficacy results from two single-arm, open-label trials: Study 201 and Study 12-230. The drug was developed by Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs. This NCCN recognition reinforces DANYELZA's position as a leading anti-GD2 therapy for treating relapsed/refractory high-risk neuroblastoma.
Y-mAbs Therapeutics (NASDAQ: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based cancer treatments, has scheduled its Q1 2025 financial results announcement for Tuesday, May 13, 2025, before market open. The company will host a conference call and webcast at 8:00 a.m. ET on the same day to discuss the results. Investors can access the webcast through Y-mAbs' Investor Relations website, where it will remain archived for at least 30 days.
Y-mAbs Therapeutics (YMAB) presented preclinical and translational pharmacokinetics data for their CD38-SADA platform at the 2025 AACR Annual Meeting in Chicago. The research focuses on their pretargeted radioimmunotherapy (PRIT) technology, specifically analyzing plasma concentrations of CD38-SADA in animal models.
Key findings revealed that CD38-SADA monomers clear 20 times faster than tetramers, supporting the platform's potential effectiveness in targeted cancer treatment. The study data has informed the design and initial dosing regimen of their Phase 1 Trial 1201 in patients with r/r NHL, with the first patient already dosed.
The SADA technology, developed at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs, involves a two-step process: a pre-targeting infusion followed by a radioactive payload delivery using Lutetium 177-DOTA.
Y-mAbs Therapeutics (YMAB) has announced the first patient dosing in its Phase 1 clinical trial evaluating CD38-SADA Pre-targeted Radioimmunotherapy for relapsed/refractory non-Hodgkin Lymphoma (r/r NHL). The trial, designated as Trial 1201, is a dose-escalation, open-label, single-arm, multi-center study investigating the CD38-SADA: 177Lu-DOTA Drug Complex.
The trial aims to assess the pre-targeted delivery of CD38-SADA protein that binds to lymphoma cells, followed by radioactive 177Lu-DOTA payload administration. Part A focuses on CD38-SADA dose escalation with fixed 177Lu-DOTA payload doses to determine optimal protein dosing and administration intervals. Primary endpoints include tumor imaging and dose limiting toxicities evaluation.
This marks Y-mAbs' second clinical program evaluating the SADA PRIT platform and first in hematological malignancies. The company has also developed GD2-SADA for GD2-expressing tumors. The SADA technology was developed at MSK and is exclusively licensed to Y-mAbs.
Y-mAbs Therapeutics (YMAB) reported Q4 2024 financial results with total revenues of $26.5 million, up 13% year-over-year, and full-year 2024 revenues of $87.7 million, a 3% increase from 2023.
Key highlights include:
- U.S. DANYELZA revenues declined 12% in Q4 and 3% for full-year 2024
- International DANYELZA revenues grew 78% in Q4 and 16% for full-year 2024
- Cash position of $67.2 million as of December 31, 2024
- Net loss of $6.8 million in Q4 2024 ($0.15 per share)
The company established two business units in January 2025 for Radiopharmaceuticals Platform and DANYELZA commercialization. 2025 guidance projects total revenues between $75-90 million and operating expenses between $116-121 million. Cash runway expected into 2027.
Y-mAbs Therapeutics (YMAB) has published interim results from a Phase 2 clinical trial of naxitamab with GM-CSF in Nature Communications. The trial evaluated patients with relapsed/refractory high-risk neuroblastoma and residual disease in bone/bone marrow.
Key findings include:
- Overall response rate (ORR) of 50% (95% CI: 36-64%, N=52)
- Complete response in 38% and partial response in 12% of patients
- Bone compartment response of 58% (29/50)
- Bone marrow compartment response of 74% (17/23)
- One-year overall survival of 93% and progression-free survival of 35%
The treatment showed manageable safety with primarily infusion-related adverse events (90%), including hypotension and bronchospasm. The study met its primary endpoint with the ORR's lower confidence interval exceeding 20%.
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