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. (Nasdaq: YMAB) is a commercial-stage biopharmaceutical company dedicated to the development and commercialization of novel, antibody-based therapeutic products for cancer treatment. The company focuses on addressing unmet medical needs, particularly in pediatric oncology, and aims to become a leader in this field.
The company's advanced product pipeline includes two pivotal-stage product candidates: naxitamab and omburtamab. Naxitamab targets tumors expressing GD2, while omburtamab targets those expressing B7-H3. Y-mAbs' flagship FDA-approved product, DANYELZA® (naxitamab-gqgk), is a recombinant humanized immunoglobulin G subtype 1k monoclonal antibody designed to treat relapsed or refractory high-risk neuroblastoma in bone or bone marrow.
Y-mAbs is also pioneering novel technologies such as the investigational Self-Assembly DisAssembly (SADA) Pretargeted Radioimmunotherapy (PRIT) platform and bispecific antibodies generated via the Y-BiClone platform. These innovative approaches aim to deliver optimal cancer therapy with minimal toxicity, leveraging existing infrastructure and enhancing patient care.
Financially, Y-mAbs has shown robust performance with increasing revenues from DANYELZA. For the fourth quarter of 2023, the company reported DANYELZA net product revenues of $23.4 million, up 42% year-over-year. The annual revenue reached $84.3 million, marking a 71% increase over the previous year. As of December 31, 2023, the company has delivered DANYELZA to 58 centers across the U.S.
In the first quarter of 2024, Y-mAbs continued its upward trajectory with U.S. DANYELZA net product revenues amounting to $18.6 million. The company maintains a strong financial foundation with approximately $75.7 million in cash and cash equivalents as of March 31, 2024, expected to support operations into 2027.
Y-mAbs collaborates with renowned institutions like Memorial Sloan Kettering Cancer Center (MSK), with exclusive licenses for technologies developed by MSK researchers. This ongoing partnership enhances Y-mAbs' capabilities in advancing their innovative therapeutic platforms.
The company's mission is clear: to transform cancer treatment outcomes by providing better and safer therapies for both children and adults. With continued advancements and strategic partnerships, Y-mAbs remains at the forefront of biopharmaceutical innovation.
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.
Y-mAbs Therapeutics (NASDAQ: YMAB) presented preclinical data and trial progress for its CD38-SADA platform at the 2024 ASH Annual Meeting. The preclinical data demonstrated selective binding and anti-tumor efficacy of CD38-SADA when used with Lutetium 177-DOTA in treating Non-Hodgkin Lymphoma (NHL).
The company also presented details of its ongoing Phase 1 Trial 1201, evaluating CD38-SADA PRIT with Lu177-DOTA in adults with relapsed or refractory NHL. The trial consists of two parts: Part A focuses on dose escalation of CD38-SADA protein, while Part B aims to establish the optimal therapeutic dose of Lu177-DOTA. Both parts follow a 3+3 trial design with 4 planned dose levels.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in radioimmunotherapy and antibody-based cancer treatments, has announced its participation in Citi's 2024 Global Healthcare Conference. The company's management team will conduct one-on-one meetings at the conference on December 4, 2024 in Miami, FL. Interested parties can schedule meetings through their Citi representative or by contacting cdu@ymabs.com.
Y-mAbs Therapeutics reported Q3 2024 financial results with total DANYELZA net product revenues of $18.5 million, marking a 10% decline from Q3 2023. The company entered into an exclusive license agreement with Nobelpharma for DANYELZA in Japan, securing a $2.0 million upfront payment. Key developments include the extension of DANYELZA's U.S. patent through February 2034 and market expansion into Turkey. Net loss for Q3 2024 was $7.0 million ($0.16 per share), compared to $7.7 million in Q3 2023. The company maintains its 2024 guidance with expected total net revenues between $87-95 million and cash position supporting operations into 2027.
Y-mAbs Therapeutics (NASDAQ: YMAB) and Nobelpharma have signed an exclusive license and distribution agreement for DANYELZA® in Japan. The agreement covers the development and commercialization of DANYELZA for treating relapsed/refractory high-risk neuroblastoma and potentially relapsed osteosarcoma. Y-mAbs will receive a $2.0 million upfront payment and could earn up to $31.0 million in milestone payments, plus profit sharing on commercial sales. Nobelpharma will handle regulatory submissions, marketing, sales, and distribution in Japan.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company focused on radioimmunotherapy and antibody-based cancer treatments, has scheduled its third quarter 2024 financial results announcement. The company will release results before market open on November 8, 2024, followed by a conference call and webcast at 8:00 a.m. ET. Domestic investors can dial (877) 407-0792, while international investors can use (201) 689-8263 to participate.
Y-mAbs Therapeutics (Nasdaq: YMAB), a commercial-stage biopharmaceutical company specializing in novel radioimmunotherapy and antibody-based therapeutic products for cancer treatment, has announced its participation in two upcoming investor conferences in October 2024:
1. Oppenheimer Targeted Radiopharmaceutical Therapies in Oncology Summit:
- Date: Tuesday, October 8, 2024
- Time: 9:30 a.m. ET
- Location: New York, NY
- Panel: "The Next Wave of TRTs – Targets, Targeting Technologies and Isotopes"
2. BMO Oncology Summit:
- Date: Tuesday, October 8, 2024
- Time: 3:00 p.m. ET
- Location: New York, NY
- Fireside chat: "Shifting the Antibody Paradigm"
These conferences provide Y-mAbs with opportunities to showcase its developments in cancer therapeutics and engage with investors.
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