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 that the European Medicines Agency (EMA) has approved its Pediatric Investigation Plan (PIP) for naxitamab, aimed at treating pediatric patients with high-risk neuroblastoma. The decision follows a positive opinion from the EMA’s Pediatric Committee. The approved PIP is a vital step, as it is necessary for filing a Marketing Authorization Application (MAA) in Europe. DANYELZA (naxitamab-gqgk), developed by researchers at Memorial Sloan Kettering Cancer Center and exclusively licensed to Y-mAbs, is already FDA-approved for similar indications.
Y-mAbs Therapeutics (Nasdaq: YMAB) has announced a strategic restructuring plan aimed at extending its cash runway and prioritizing the commercialization of DANYELZA. The company expects a 28% reduction in annual operating expenses for 2023, targeting $115-120 million, and plans to decrease cash burn to $50-55 million. DANYELZA's projected net revenues for 2023 are estimated at $60-65 million. The restructuring includes a 35% workforce reduction and deprioritization of several pipeline programs, focusing on DANYELZA growth and the SADA technology development.
Y-mAbs Therapeutics announced the participation of founder and President Thomas Gad at the virtual 41st Annual J.P. Morgan Healthcare Conference, scheduled for January 11, 2023, at 5:15 PM EST. Y-mAbs, listed on Nasdaq as YMAB, focuses on developing innovative, antibody-based cancer treatments. The company’s portfolio includes the FDA-approved DANYELZA® and the registration-stage candidate OMBLASTYS®. The press release also outlines potential forward-looking statements regarding product developments, clinical studies, and market strategies.
Y-mAbs Therapeutics (Nasdaq: YMAB) has announced a distribution agreement with WEP Clinical for an early access program for its cancer treatment, DANYELZA (naxitamab-gqgk), in Europe. DANYELZA, a humanized monoclonal antibody targeting GD2, is already FDA-approved for high-risk neuroblastoma in the U.S. The initial rollout will be in Spain and France, with potential expansion to other regions. This partnership aims to provide European patients access to DANYELZA while Y-mAbs continues to develop its oncology pipeline.
Y-mAbs Therapeutics (YMAB) announced that the European Committee for Medicinal Products for Human Use (CHMP) has issued a negative opinion regarding the marketing authorization of omburtamab for treating CNS/leptomeningeal metastasis from neuroblastoma in Europe. The committee deemed it impossible to conclude the drug's effectiveness without a randomized comparator in the main study. CEO Thomas Gad expressed disappointment, emphasizing the critical need for approved therapies in this area. The company will evaluate the implications of this decision on the omburtamab program.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a clinical update for naxitamab and its SADA technology programs at an R&D event on December 14, 2022. The Company discussed significant advancements, including a proprietary SADA construct targeting CD38 for Non-Hodgkin’s Lymphoma and updates on GD2-SADA in Phase 1 trials. Also highlighted was the potential label expansion for DANYELZA® (naxitamab-gqgk) into osteosarcoma, along with plans for a Phase 2 trial in high-risk neuroblastoma patients. The event featured key presentations from the Company's leadership.
Y-mAbs Therapeutics announced that the National Medical Products Administration in China granted DANYELZA (naxitamab-gqgk) conditional approval. This humanized monoclonal antibody targets ganglioside GD2 in high-risk neuroblastoma cases.
DANYELZA will be marketed through SciClone Pharmaceuticals. The treatment, in conjunction with GM-CSF, is approved for patients aged 1 year and older who have shown partial or stable response to prior therapies. Continued approval may depend on success in a confirmatory trial.
Y-mAbs Therapeutics (Nasdaq: YMAB) will host its annual Research and Development Day on December 14, 2022, at 9:00 am ET in New York. The event will showcase key presentations about the company's clinical developments and product pipeline. Presenters include Thomas Gad, Steen Lisby, and Vignesh Rajah, who will discuss corporate updates, SADA technology, and the DANYELZA® (naxitamab-gqgk) label expansion into osteosarcoma. A Q&A session will follow the presentations, providing attendees with the opportunity to engage and inquire about the company's strategies and advancements.
The FDA issued a complete response letter (CRL) for Y-mAbs Therapeutics' Biologics License Application (BLA) regarding the investigational drug 131I-omburtamab for treating CNS/leptomeningeal metastasis from neuroblastoma. The decision aligns with the previous outcome of the October advisory committee meeting. Y-mAbs is now evaluating the next steps for the omburtamab program while focusing on growth from its FDA-approved product, DANYELZA. The company holds a pipeline that includes innovative cancer therapeutics.
Y-mAbs Therapeutics reported record revenues of $12.5 million for Q3 2022, reflecting a 40% year-over-year increase and a 28% sequential growth from Q2 2022. The company has granted marketing authorization for DANYELZA in Israel and submitted a regulatory filing in Brazil. With a cash position of $114.5 million, management anticipates a full-year revenue for DANYELZA between $45-$50 million. However, the company's recent ODAC meeting outcome for omburtamab was disappointing, raising concerns about future approvals.
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