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 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.
Y-mAbs Therapeutics announced it received a Refusal to File letter from the FDA for its Biologics License Application (BLA) of omburtamab, aimed at treating pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The FDA cited the need for additional details in the Chemistry, Manufacturing and Control module and the Clinical module of the BLA. Y-mAbs plans to address these concerns and resubmit the BLA by year-end 2020, following a Type A meeting with the FDA. An investor call is set for October 6, 2020, to discuss this update.
Y-mAbs Therapeutics reported its second quarter 2020 financial results, highlighting a net loss of $40.4 million, or $1.01 per share, compared to a loss of $18.0 million in Q2 2019. The company completed its omburtamab BLA submission and received FDA priority review for naxitamab. R&D expenses surged to $30.1 million due to increased milestones and personnel costs. General and administrative costs also rose to $10.4 million. As of June 30, 2020, Y-mAbs had $158.1 million in cash, down from $207.1 million at year-end 2019.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced the submission of its Biologics License Application for omburtamab on August 5, 2020. This investigational monoclonal antibody targets B7-H3 to treat pediatric CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on pivotal Phase 2 study results. The company aims to address an unmet medical need as no standard therapies are available for these patients. Y-mAbs has additional studies planned for omburtamab in other cancer types.
Y-mAbs Therapeutics (YMAB) announced acceptance of five oral presentations for its lead product naxitamab at the SIOP Virtual Annual Congress, scheduled for October 14-17, 2020. Naxitamab is under priority review by the FDA for relapsed/refractory high-risk neuroblastoma, with an action date of November 30, 2020. The company also reported on omburtamab and its GD2-GD3 vaccine candidates, indicating progress in clinical trials. Y-mAbs continues to focus on developing antibody-based therapies for pediatric cancers.
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