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 SciClone Pharmaceuticals has submitted a Biologics License Application (BLA) for DANYELZA® (naxitamab-gqgk) to China's National Medical Products Administration (NMPA) for treating relapsed/refractory high-risk neuroblastoma. This submission follows FDA approval within just seven months, indicating rapid progress in making the innovative therapy available to pediatric patients in China. Y-mAbs emphasizes the strategic collaboration with SciClone to ensure timely market entry if approved.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced a positive opinion from the EMA's Committee for Orphan Medicinal Products for 177Lu-omburtamab-DTPA, targeting medulloblastoma. This recommendation supports orphan drug designation, expected to be granted by the European Commission within 30 days. The designation will provide development incentives and 10 years of market exclusivity upon approval, enhancing Y-mAbs' European expansion plans. The company aims to improve treatment options for patients with this rare and life-threatening condition.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced the conclusion of a Type B meeting with the FDA regarding its drug omburtamab for treating pediatric neuroblastoma patients with CNS/metastatic conditions. The company believes it gained clarity on resubmitting the Biologics License Application (BLA) after discussing statistical analysis plans. Y-mAbs plans to provide additional data to the FDA in Q3 2021 and aims for a rolling BLA resubmission by year-end. The approval of omburtamab could fulfill an unmet medical need in pediatric oncology.
Y-mAbs Therapeutics, focused on innovative cancer treatments, announced the presentation of three-year follow-up data for DANYELZA and GM-CSF in high-risk neuroblastoma patients at the ASCO Virtual Annual Meeting on June 4, 2021. The study included 73 patients, showing a three-year event-free survival of 74% for first complete remission and 19% for later remissions. Overall survival rates were 92% and 66%, respectively. The positive data suggests DANYELZA's potential to differentiate itself from existing therapies if approved.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced interim results from a phase 1 dose-escalation study for omburtamab targeting diffuse intrinsic pontine glioma (DIPG) at the ASCO Virtual Annual Meeting on June 4, 2021. The study demonstrated good tolerability with a median overall survival improvement of 3-4 months over historical controls. The company plans to advance this promising candidate into a phase 2 study later this year, further expanding the omburtamab franchise to include other CNS tumors. The study's positive data marks a significant step in addressing an unmet medical need in cancer treatment.
Y-mAbs Therapeutics announced an exclusive distribution agreement with Adium Pharma for Latin America, covering DANYELZA® and the investigational drug omburtamab. DANYELZA, approved by the FDA in 2020, targets high-risk neuroblastoma in pediatric patients. Omburtamab is pending approval for CNS metastasis treatment. The agreement grants Adium distribution rights in 18 countries, enhancing market access. Y-mAbs aims to submit further applications for omburtamab by late Q2 or early Q3 2021. Financial terms were not disclosed.
Y-mAbs Therapeutics announced a presentation by Dr. Nai-Kong V. Cheung at the PEGS Boston Virtual Conference on May 13, 2021, focusing on their SADA technology platform for cancer treatment. The SADA technology aims to enhance the therapeutic index in radioimmunotherapy, potentially improving treatment outcomes while minimizing toxicity. Y-mAbs is a biopharmaceutical company with a strong pipeline, including the FDA-approved DANYELZA® and the pivotal-stage candidate omburtamab. The technology is exclusively licensed from Memorial Sloan Kettering Cancer Center and MIT.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) reported strong financial results for Q1 2021, with net income of $33.4 million, or $0.80 per basic share, driven by DANYELZA® sales and Priority Review Voucher monetization. Revenue reached $5.4 million from DANYELZA, marking significant growth from zero in Q1 2020. Operating expenses increased, with R&D expenses at $21.6 million and SG&A expenses at $12.0 million. Cash and equivalents totaled $252 million, providing a solid position for advancing their pipeline, including the application for omburtamab in Europe.
Y-mAbs Therapeutics (Nasdaq: YMAB) will release its Q1 2021 financial results on May 6, 2021, followed by a conference call on May 7, 2021, at 9 a.m. ET. The call will include updates from key executives: Chairman Thomas Gad, CEO Dr. Claus Moller, and CFO Bo Kruse. Y-mAbs focuses on developing antibody-based cancer therapies, with one FDA approved product, DANYELZA®, and another candidate, omburtamab, in pivotal stages. Forward-looking statements are included, highlighting potential risks in clinical trials and market acceptance.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has announced the acceptance of two poster presentations for DANYELZA and an oral presentation for omburtamab at the American Society of Clinical Oncology Virtual Annual Meeting from June 4-8, 2021. Key topics include the efficacy of naxitamab in high-risk neuroblastoma and a Phase 1 trial of omburtamab for diffuse intrinsic pontine glioma. The collaborations involve researchers from Memorial Sloan Kettering Cancer Center and SJD Barcelona Children's Hospital. Y-mAbs focuses on antibody-based cancer therapeutics, with a pipeline including DANYELZA, which is FDA-approved.
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