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 (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%.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on developing novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment, has announced it will release its fourth quarter and full year 2024 financial results before market open on Tuesday, March 4, 2025.
The company will host a conference call and webcast to discuss the results on March 4, 2025, at 8:00 a.m. ET. Interested parties can register for the live conference call, and a webcast will be available on the company's Investor Relations website, remaining accessible for at least 30 days afterward.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based therapeutic products for cancer treatment, has announced its participation in the Oppenheimer 35th Annual Life Sciences Conference.
The company's President and CEO, Michael Rossi, will engage in a fireside chat scheduled for Tuesday, February 11, 2025, at 4:40 p.m. ET. Investors and interested parties can access a live webcast of the presentation through the Events section on Y-mAbs' investor relations website at ir.ymabs.com. The presentation recording will remain available for replay on the website for 30 days following the event.
Y-mAbs Therapeutics (YMAB) presented preclinical and translational pharmacokinetics data of GD2-SADA at the SNMMI Mid-Winter and ACNM Annual Meeting in Anaheim. The presentation focused on plasma levels of GD2-SADA in animal models across various doses and time periods, along with concentration-dependent equilibrium between GD2-SADA tetramers and monomers in vitro.
The research has provided important insights into GD2-SADA tumor exposure and plasma elimination, which are key parameters for minimizing systemic exposure to 177Lutetium-DOTA. According to Norman LaFrance, Chief Development Officer, the human PK model of GD2-SADA has informed the design and initial dosing regimen of their ongoing first-in-human Phase 1 Trial (Trial 1001).
The SADA technology for radioimmunotherapy was developed at Memorial Sloan Kettering Cancer Center and is exclusively licensed to Y-mAbs.
Y-mAbs Therapeutics (NASDAQ: YMAB) announced strategic updates and 2025 priorities, establishing two business units: Radiopharmaceuticals and DANYELZA. The company reported preliminary unaudited total net revenue of approximately $88 million for 2024, within guidance, and cash position of $67 million as of December 31, 2024, expected to support operations into 2027.
The company's GD2-SADA Phase 1 trial has dosed 21 patients across six sites, with preliminary data showing good tolerability and no dose-limiting toxicities. Y-mAbs plans to present Part A data in Q2 2025. The business restructuring includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the US to optimize radiopharmaceutical platform advancement.
The company expects to dose its first patient in the CD38-SADA Phase 1 trial in Q1 2025 and anticipates potential marketing approval for DANYELZA in new ex-US markets in 2025.
Y-mAbs Therapeutics (Nasdaq: YMAB) has appointed Doug Gentilcore as Senior Vice President, Head of DANYELZA Business Unit. This appointment comes as part of the company's strategy to expand the commercial potential of DANYELZA beyond pediatric oncology. Gentilcore brings over 20 years of pharmaceutical industry experience, previously serving as CEO of ARTMS, Inc. and founding Implerem, His background includes leadership roles at Jubilant Radiopharma, General Electric Healthcare Division, and Pfizer Pharmaceuticals.
The appointment coincides with the departure of Chief Commercial Officer Sue Smith, who led the U.S. Commercial team and DANYELZA relaunch. The company believes Gentilcore's extensive experience in pharmaceutical commercialization and global operations will be important for DANYELZA's growth strategy.
Y-mAbs Therapeutics (YMAB) announces strategic reorganization into two business units: Radiopharmaceuticals and DANYELZA. The company reports preliminary unaudited total net revenue of approximately $88 million for 2024, within guidance, and cash position of $67 million as of December 31, 2024, expected to support operations into 2027.
The company's GD2-SADA Phase 1 trial has dosed 21 patients across six sites, showing promising tolerability with no dose-limiting toxicities. Part A data presentation is expected in Q2 2025. The reorganization includes a workforce reduction of up to 13% and relocation of some roles from Denmark to the U.S.
Key 2025 milestones include presenting GD2-SADA optimization data, dosing the first patient in CD38-SADA Phase 1 trial in Q1, and potential DANYELZA marketing approval in new ex-U.S. markets.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based cancer treatments, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Michael Rossi, President and CEO, will deliver a presentation on January 15, 2025, at 5:15 p.m. PT in San Francisco.
The presentation will be accessible via live webcast through the Events section of Y-mAbs' investor relations website at ir.ymabs.com. The recording will remain available for replay for 30 days following the event.
