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 (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.
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.
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