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) generates news that spans commercial oncology performance, clinical development milestones in radioimmunotherapy, and significant corporate transactions. Company announcements consistently describe Y-mAbs as a commercial-stage biopharmaceutical company focused on novel radioimmunotherapy and antibody-based therapeutic products for the treatment of cancer, with its lead commercial asset DANYELZA® (naxitamab-gqgk) for relapsed or refractory high-risk neuroblastoma.
News coverage for Y-mAbs frequently highlights financial results and segment updates, including quarterly revenue from DANYELZA, ex-U.S. distribution trends, and the allocation of resources between the DANYELZA and Radiopharmaceuticals business units. Earnings releases often discuss cost of goods sold, research and development spending, selling, general, and administrative expenses, and net loss, along with management commentary on operating strategy and capital efficiency.
Another major category of YMAB news involves clinical and R&D developments in the company’s SADA Pretargeted Radioimmunotherapy (PRIT) platform. Press releases describe progress in the GD2-SADA Phase 1 Trial 1001 in GD2-expressing solid tumors, including pharmacokinetic and dosimetry data, and the initiation of the CD38-SADA Phase 1 Trial 1201 in relapsed or refractory non-Hodgkin lymphoma. Y-mAbs also reports on preclinical pharmacokinetic modeling, optimization of radiohaptens such as “Proteus,” and expansion of its radiopharmaceutical pipeline into additional oncology franchises.
Y-mAbs news also covers regulatory and guideline recognition, such as the inclusion of naxitamab-gqgk (DANYELZA) as a Category 2A treatment option in the National Comprehensive Cancer Network® (NCCN®) Clinical Practice Guidelines in Oncology for Neuroblastoma. These updates provide context on how DANYELZA is positioned within clinical practice for high-risk neuroblastoma.
A key theme in recent YMAB headlines is corporate transformation and acquisition activity. In August 2025, Y-mAbs announced that SERB Pharmaceuticals, through an affiliate, agreed to acquire the company in an all-cash transaction at $8.60 per share, with an equity value of approximately $412 million, as described in joint press releases and Form 8-K filings. Subsequent news and SEC filings report the commencement and completion of the tender offer, the closing of the merger, and the resulting delisting of Y-mAbs common stock from the Nasdaq Global Select Market.
Investors and observers following YMAB-related news can expect updates on quarterly financial performance, DANYELZA commercial metrics, clinical trial progress for SADA-based programs, radiopharmaceutical R&D strategy, and the implications of the company’s acquisition by an affiliate of SERB Pharmaceuticals. This news flow provides insight into both the historical public-company phase of Y-mAbs and its transition into a privately held subsidiary within a larger specialty pharmaceutical group.
Y-mAbs Therapeutics (Nasdaq: YMAB) will host a virtual R&D day on December 16, 2020, from 12 PM to 2 PM ET. Key Opinion Leaders, including Dr. Shakeel Modak from Memorial Sloan Kettering, will present topics on DANYELZA® (naxitamab-gqgk) and its combination with chemotherapy, along with updates on other studies related to osteosarcoma and DIPG. Management will detail advancements regarding their bispecific antibody, nivatrotamab, and additional products. Participants can register for the event online.
Y-mAbs Therapeutics (Nasdaq: YMAB) has partnered with Takeda Israel to establish an exclusive license and distribution agreement for DANYELZA and omburtamab in Israel. DANYELZA, which received FDA approval on November 25, 2020, treats relapsed/refractory high-risk neuroblastoma. Meanwhile, Y-mAbs plans to resubmit the BLA for omburtamab by early 2021. This agreement will facilitate access to these critical treatments for pediatric patients in Israel and surrounding regions, addressing unmet medical needs.
Y-mAbs Therapeutics announced FDA approval for DANYELZA (naxitamab-gqgk) 40mg/10ml, indicated for treating high-risk neuroblastoma in patients aged one and older. DANYELZA, combined with granulocyte-macrophage colony-stimulating factor (GM-CSF), targets GD2, a ganglioside in neuroectoderm-derived tumors. This accelerated approval requires further clinical trials to confirm benefits. DANYELZA is expected in U.S. markets soon, supported by two pivotal studies showing manageable adverse events, enhancing Y-mAbs' oncology product pipeline.
Y-mAbs Therapeutics announced a clinical update on its treatment, omburtamab, for diffuse intrinsic pontine glioma (DIPG) during the SNO Virtual Annual Meeting. Data from a Phase 1 study indicated that repeated convection enhanced delivery (CED) infusions are feasible in pediatric patients. The study involved seven patients receiving multiple infusions without negatively impacting procedural aspects. Y-mAbs plans a multicenter Phase 2 trial aimed at improving outcomes for DIPG patients.
Y-mAbs Therapeutics reported a net loss of $32.8 million or ($0.82) per share for Q3 2020, compared to a $23.9 million loss in Q3 2019. Research and development expenses rose to $21.0 million, while general and administrative costs increased to $11.6 million.
Despite the financial losses, Y-mAbs is progressing with its pipeline, including a planned resubmission of the omburtamab BLA and advancements in nivatrotamab, which received Orphan Drug and Rare Pediatric Disease designations from the FDA.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) will report its financial results for Q3 2020 on November 5, 2020, after U.S. market close. A conference call will follow on November 6, 2020, at 9 a.m. ET, featuring Thomas Gad, Dr. Claus Moller, and Bo Kruse. Y-mAbs focuses on developing antibody-based therapies for cancer, with key candidates naxitamab and omburtamab targeting GD2 and B7-H3 tumors, respectively. The press release includes forward-looking statements regarding the company's business model, clinical trials, and potential risks related to financial conditions and product development.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced FDA clearance for its Investigational New Drug (IND) application for 177Lu-omburtamab-DTPA. This treatment targets B7-H3 positive CNS and Leptomeningeal Metastasis in adult patients. The company plans to initiate a Phase 1/2 clinical trial in Q4 2020, leveraging experience from treating adults with 131I-omburtamab. Y-mAbs aims to address unmet medical needs in brain metastasis and expand its clinical reach.
Y-mAbs Therapeutics (YYMB) announced significant clinical updates on its therapies naxitamab and omburtamab at the SIOP Virtual Annual Congress. Naxitamab demonstrated a 68% overall response rate, with 59% achieving complete responses in a pivotal study of 22 patients. Meanwhile, omburtamab showed a promising 87% overall survival rate at 12 months in a study of 17 patients, compared to 30% in a historical control. The FDA has set a PDUFA date for naxitamab on November 30, 2020, indicating potential market entry for these novel cancer treatments.
Y-mAbs Therapeutics has received FDA clearance for its Investigational New Drug application for 177Lu-omburtamab-DTPA, aimed at treating medulloblastoma, a common childhood brain cancer. This product utilizes a radiolabeled antibody and is scheduled for a Phase 1/2 clinical trial targeting pediatric patients later in 2020. The company plans to also initiate a separate trial for adults with B7-H3 positive CNS/LM cancers. The omburtamab antibody was developed by Memorial Sloan Kettering, which has financial interests in Y-mAbs.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced the FDA's grant of Orphan Drug Designation and Rare Pediatric Disease Designation for its bispecific antibody nivatrotamab, aimed at treating neuroblastoma. This designation provides potential market exclusivity of seven years post-approval and eligibility for a Priority Review Voucher. Currently in Phase 1 trials, nivatrotamab is developed in collaboration with Memorial Sloan Kettering Cancer Center and will expand into Phase 2 studies for neuroblastoma and osteosarcoma, as well as a new study in small cell lung cancer expected to begin in Q4 2020.
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