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 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.
Y-mAbs Therapeutics (YMAB) will announce its Q3 2022 financial results on November 7, 2022, post-market. This will be followed by a conference call on November 8, 2022, at 4:00 PM ET, featuring key executives including Interim CEO Thomas Gad and CFO Bo Kruse. Y-mAbs specializes in developing antibody-based cancer therapies, with one FDA-approved product, DANYELZA, and another candidate, omburtamab, at the registration stage. The press release also contains forward-looking statements regarding the company’s plans and potential risks.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced that the FDA's Oncologic Drugs Advisory Committee voted 16-0 against the effectiveness of 131I-omburtamab for treating CNS/leptomeningeal metastasis from neuroblastoma, citing insufficient evidence for improved overall survival. Despite this setback, Y-mAbs intends to collaborate with the FDA on the Biologic License Application, which is undergoing Priority Review with a target decision date of November 30, 2022. The company remains committed to finding effective treatment options for patients in need.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced promising interim clinical data for its candidate OMBLASTYS® (131I-omburtamab) aimed at treating CNS/leptomeningeal metastasis in neuroblastoma patients. Presenting at the SIOP Annual Congress, results from 32 patients indicated a twelve-month overall survival of 73.5% and a 31.3% objective response rate. The treatment, showing significant disease control in 75% of patients, is vital for addressing unmet medical needs. Y-mAbs anticipates filing for regulatory approval by the PDUFA date of November 30, 2022.
Y-mAbs Therapeutics (NASDAQ: YMAB) announced that its partner Adium Pharma has submitted a regulatory filing for DANYELZA® (naxitamab-gqgk) to the Brazilian Health Regulatory Agency, Anvisa, for treating relapsed/refractory high-risk neuroblastoma. This filing is viewed as a significant milestone in making DANYELZA globally available to meet the medical need in Brazil. The drug is already approved in the U.S. for pediatric and adult patients under specific conditions and includes warnings for serious reactions.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced a meeting of the Oncologic Drugs Advisory Committee (ODAC) scheduled for October 28, 2022, to review its Biological License Application (BLA) for OMBLASTYS® (omburtamab). The BLA was resubmitted on March 31, 2022, with a PDUFA goal date of November 30, 2022. The company aims to provide treatment for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. OMBLASTYS is a radiolabeled antibody construct developed at Memorial Sloan Kettering Cancer Center, licensed exclusively to Y-mAbs.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announces the Israeli Ministry of Health's approval of DANYELZA for pediatric and adult patients with relapsed or refractory high-risk neuroblastoma. This approval marks Y-mAbs' first marketing authorization outside the U.S. and will allow Takeda Israel to commercialize the product under an exclusive distribution agreement. The approval follows expedited reimbursement by the Ministry, enhancing treatment options for patients. DANYELZA, associated with serious infusion-related reactions, aims to address unmet medical needs in oncology.
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