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 revenue of $10.8 million for Q2 2022, a slight decrease of 1% year-over-year, while YTD revenue was $21.3 million, reflecting a 30% increase. DANYELZA® sales rose 42% YTD to $20.3 million. The company has a strong cash position of $133.7 million, expected to fund operations through mid-2024. The FDA has accepted their BLA for omburtamab with a PDUFA date set for November 2022. Management reiterated financial guidance, aiming for DANYELZA revenues between $45-$50 million for the full year.
Y-mAbs Therapeutics (Nasdaq: YMAB) will announce its financial results for Q2 2022 on August 8, 2022, post-market. A conference call will follow on August 9, 2022, at 9 a.m. ET, featuring key executives including Chairman and Interim CEO Thomas Gad. Y-mAbs aims to advance antibody-based cancer therapies, with one FDA-approved product, DANYELZA®, and another candidate, omburtamab, nearing registration. The firm emphasizes its innovative approaches alongside potential risks inherent in drug development and market acceptance.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced the initiation of a Phase 1 clinical trial utilizing the GD2-SADA construct to treat malignant melanoma, sarcoma, and small cell lung cancer. The trial, which will enroll approximately 59 patients across 6-10 U.S. sites, consists of three parts focusing on dose optimization and safety. The SADA technology, licensed from MSK and MIT, aims to enhance targeted cancer treatment while minimizing harm to normal tissues. The FDA has accepted the IND for GD2-SADA, marking a significant milestone in Y-mAbs' clinical development strategy.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) announced that the FDA has accepted the Biologics License Application for OMBLASTYS® (omburtamab) to treat pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma for priority review. The FDA set an action date of November 30, 2022, and plans an advisory committee meeting in October 2022. CEO Thomas Gad highlighted that this approval could address a significant unmet medical need and potentially add a second rare disease product to Y-mAbs' portfolio, without significant infrastructure investment.
Y-mAbs Therapeutics announced that Dr. Shakeel Modak will present results from a trial of naxitamab-based chemoimmunotherapy for high-risk neuroblastoma at the ASCO Annual Meeting from June 3-7, 2022. The trial focused on patients with chemoresistant disease, showing a 30.6% objective response rate in the MSK phase 2 trial, with significant responses in heavily pre-treated patients. The treatment showed manageable toxicity, with no unexpected severe side effects. Y-mAbs is advancing its antibody-based therapeutics in cancer treatment.
Y-mAbs Therapeutics reported a 9% sequential revenue increase to $10.5 million for Q1 2022, driven by DANYELZA® sales. The Company anticipates full-year DANYELZA revenues between $45 million and $50 million. Y-mAbs maintains a solid cash position with $156.7 million as of March 31, 2022, expected to fund operations through mid-2024. However, the Company posted a net loss of $28.1 million for the quarter, a decline from net income of $33.4 million in Q1 2021, primarily due to a one-time gain from a prior sale.
Y-mAbs Therapeutics announced it will report its financial results for Q1 2022 on May 9, 2022, after U.S. market close. A conference call is scheduled for May 10, 2022, at 9 a.m. ET with executives including Thomas Gad, Bo Kruse, and Sue Smith. The company is involved in developing antibody-based cancer therapies, with one FDA-approved product, DANYELZA®, and another candidate, omburtamab, in the registration stage. For more information, investors can join the conference call using specific access numbers and a provided webcast link.
Y-mAbs Therapeutics announces significant management changes, with Dr. Claus Moller stepping down as CEO and Board Member. Thomas Gad, the Founder and Chairman, assumes the role of Interim CEO while Dr. Jim Healy is appointed as Chairman. The company reported first-quarter 2022 revenues of $10.5 million, a 9% increase sequentially, and provided revenue guidance of $45-$50 million for the year. As of March 31, 2022, Y-mAbs has $156.7 million in cash, ensuring funding until mid-2024, amidst ongoing regulatory review of their product omburtamab.
Y-mAbs Therapeutics (Nasdaq: YMAB) announced a poster presentation at the AACR Annual Meeting 2022 in New Orleans, showcasing preclinical data on its GD2 SADA construct. The SADA technology, licensed from Memorial Sloan Kettering and MIT, enhances tumor antigen binding and anti-tumor responses. Y-mAbs is focused on antibody-based cancer therapies and has one FDA-approved product, DANYELZA, aimed at GD2-expressing tumors, and another candidate, omburtamab, targeting B7-H3-expressing tumors.
Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) has resubmitted its Biologics License Application (BLA) for 131I-omburtamab to the FDA as of March 31, 2022. This investigational monoclonal antibody targets B7-H3 in pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is informed by pivotal Phase 2 study results, expected to be published later this year. Y-mAbs aims to meet a critical medical need, as there are currently no effective treatments beyond surgery and radiotherapy for these patients.
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