Y-Mabs Therapeutics Inc

Y-mAbs Therapeutics, Inc. is a clinical-stage biopharmaceutical company, which focuses on the development and commercialization of antibody based therapeutic products for the treatment of cancer. Its services include discovery, protein engineering, clinical and regulatory. Y-mAbs Therapeutics was founded by Thomas Gad in April 2015 and is headquartered in New York, NY.

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Y-Mabs Therapeutics reports record revenues and strategic growth initiatives

Y-Mabs Therapeutics demonstrated strong financial performance in Q4 2022, with record revenues and effective cost management.
The company's focus on product development and market expansion, coupled with strategic restructuring, positions it for sustainable growth.
While facing financial challenges and competitive pressures, Y-Mabs Therapeutics has opportunities for portfolio expansion and market penetration.

Y-Mabs Therapeutics Inc achieves record revenue, eyes international expansion

Y-Mabs Therapeutics Inc reported strong performance in Q1 2023, driven by record net product revenue and positive sales trends for DANYELZA.
The company's focus on R&D, commercialization efforts, and strategic partnerships positions it well for future growth and market expansion.
While facing challenges such as market competition and restructuring, Y-Mabs Therapeutics Inc has opportunities to capitalize on its innovative technologies and market presence.
With updated financial guidance and a clear roadmap for product development, the company is poised for continued success and revenue growth in 2023.

Y-Mabs reports robust Q2 earnings, eyes international expansion and label growth

Y-Mabs Therapeutics Inc demonstrated strong financial performance with notable revenue growth for DANYELZA and advancements in their SADA platform.
While facing challenges in competitive dynamics and treatment optimization, the company is strategically positioned for international market expansion and revenue diversification.
Opportunities lie in market penetration strategies, upcoming label expansions, and continued product development efforts, indicating a positive outlook for future growth and innovation.

Y-Mabs Therapeutics reports strong Q3 performance and eyes oncology expansion

Y-Mabs Therapeutics showcased robust financial performance, strong commercial traction for DANYELZA, and promising advancements in the SADA platform.
While facing challenges in scalability and dose optimization, the company's strategic strengths lie in leadership changes, clinical progress, and market penetration.
Opportunities for growth include expanding indications, optimizing treatment protocols, and enhancing visibility through data presentations and partnerships.

Y-mAbs reports strong Q4 earnings, eyes global expansion and program innovations

Y-mAbs Therapeutics showcased robust financial performance in Q4 2023, driven by strong DANYELZA net product sales and revenue growth.
Effective cost management, expansion plans into key markets, and enhanced marketing efforts position the company for continued success.
While facing challenges in managing expenses and addressing analyst inquiries, Y-mAbs has opportunities for growth through international expansion and program innovations.

Y-mAbs reports record DANYELZA sales, eyes global expansion and innovation

Y-mAbs Therapeutics showcased robust financial performance with record DANYELZA sales, underpinned by strategic expansion efforts and progress in clinical programs.
While facing questions on growth strategies and potential seasonality challenges, the company's strong balance sheet and focus on innovation position it well for future success.
By emphasizing responsible capital allocation, global expansion, and advancements in cancer treatment options, Y-mAbs is poised to navigate challenges and seize opportunities for sustained growth.

Y-mAbs Therapeutics reports revenue growth and promising clinical outcomes

Y-mAbs Therapeutics Inc. delivered solid financial performance, strong product sales, and promising clinical trial outcomes in Q2 2024, positioning the company for continued growth.
While facing challenges in managing cash burn and sustaining revenue growth, the company's commitment to innovation and patient care presents opportunities for future success.
With a revised revenue guidance and focus on advancing novel therapies, Y-mAbs Therapeutics Inc. remains dedicated to improving patient lives and driving growth in the biopharmaceutical sector.

Y-Mabs Therapeutics reports mixed Q3 performance with growth opportunities

Y-Mabs Therapeutics faced challenges with declining DANYELZA revenues outside the U.S.
However, the company demonstrated strengths in securing long-term exclusivity and expanding market reach.
Opportunities lie in leveraging partnerships, exploring new targets, and ongoing clinical trials.
Maintaining financial stability and meeting full-year guidance are key priorities for future growth.

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NEW YORK and PETACH TIKVA, Israel, Dec. 04, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (Nasdaq: YMAB) (the “Company” or “Y-mAbs”) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer and Takeda Israel, a wholly owned subsidiary of Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK) (“Takeda”) announced today that they have entered into an exclusive license and distribution agreement for the registration and commercialization in Israel of DANYELZA for the treatment of patients with relapsed/refractory high-risk neuroblastoma and omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. DANYELZA (naxitamab-gqgk) was approved by the U.S. FDA on November 25, 2020. Additionally, Y-mAbs plans to resubmit the amended BLA for omburtamab for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma to the FDA by the end of 2020 or in early 2021.

Y-mAbs and Takeda Announce Exclusive License and Distribution Agreement for DANYELZA® (naxitamab-gqgk) and Omburtamab in Israel

NEW YORK, Nov. 25, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the U.S. Food and Drug Administration (“FDA”) has approved DANYELZA (naxitamab-gqgk) 40mg/10ml. DANYELZA is indicated, in combination with granulocyte-macrophage colony-stimulating factor (“GM-CSF”), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy. This indication is approved under accelerated approval regulation based on overall response rate and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefits in a confirmatory trial. DANYELZA is a humanized, monoclonal antibody that targets the ganglioside GD2, which is highly expressed in various neuroectoderm-derived tumors and sarcomas. DANYELZA is administered to patients three times in a week in an outpatient setting and the treatment is repeated every four weeks. The product has received Priority Review, Orphan Drug, Breakthrough Therapy, and Rare Pediatric Disease designations from the FDA.

FDA Approves Y-mAbs' DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma

NEW YORK, Nov. 19, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced a clinical update on omburtamab for the treatment of diffuse intrinsic pontine glioma (“DIPG”). Data was presented at the Society for Neuro-Oncology (“SNO”) Virtual Annual Meeting held November 19 through November 21, 2020. The omburtamab data was presented by Dr. Evan Bander from Weill Cornell Medicine.

Y-mAbs Announces Update on Omburtamab in DIPG

Y-mAbs Therapeutics, Inc. (YMAB) CEO Claus Moller on Q3 2020 Results - Earnings Call Transcript

NEW YORK, Oct. 26, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that the U.S. Food and Drug Administration (“FDA”) has cleared the Company's Investigational New Drug (“IND”) application for 177Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nervous System (“CNS”) and Leptomeningeal Metastasis (“LM”) from tumors in adult patients.

Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications

NEW YORK, Oct. 16, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced clinical updates on naxitamab for the treatment of relapsed/refractory high-risk neuroblastoma and omburtamab for CNS/leptomeningeal metastasis from neuroblastoma. Data was presented at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The naxitamab data was presented by Dr. Jaume Mora from SJD Barcelona Children's Hospital, and the omburtamab data was presented by Dr. Kim Kramer from Memorial Sloan Kettering Cancer Center (“MSK”).

Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma

NEW YORK, Oct. 07, 2020 (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the FDA has granted Orphan Drug Designation (“ODD”) and Rare Pediatric Disease Designation (“RPDD”) for its leading bispecific antibody program nivatrotamab for the treatment of neuroblastoma.

Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA

Y-mAbs Is One To Accumulate Before PDUFA

Y-mAbs Therapeutics, Inc. (YMAB) CEO Claus Moller on Q2 2020 Results - Earnings Call Transcript

NEW YORK, Aug.  06, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today reported financial results for the second quarter 2020.

Y-mAbs Announces Second Quarter 2020 Financial Results and Recent Corporate Developments

NEW YORK, Aug.  06, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that on August 5, 2020, the Company completed the submission of its Biologics License Application (“BLA”) under the FDA’s Rolling Review process for omburtamab. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma. The submission is based on the safety and efficacy results of the pivotal Phase 2 studies 101 and 03-133, which the Company expects to present at a venue later this year.

Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA

NEW YORK, Aug.  04, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) today announced that it will report its financial results for the second quarter ended June 30, 2020 on Thursday, August 6, 2020, after the close of the U.S. financial markets. The announcement will be followed by a conference call and webcast with the investment community on Friday, August 7, 2020, at 9 a.m. ET.  Participating on the call from Y-mAbs will be Thomas Gad, Founder, Chairman and President; Dr. Claus Moller, Chief Executive Officer; and Bo Kruse, Chief Financial Officer.

Y-mAbs to Announce Second Quarter 2020 Financial and Operating Results on August 6, 2020

NEW YORK, July  27, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, is pleased to announce the acceptance of five oral presentations at the International Society of Pediatric Oncology (“SIOP”) Virtual Annual Congress held October 14 through October 17, 2020 in Ottawa, Canada. The abstracts are publicly available online at https://siop-congress.org/scientific-programme/

Y-mAbs Announces Data to be Presented at 2020 SIOP

NEW YORK, July  14, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that Brian H. Santich, PhD, from Memorial Sloan Kettering (“MSK”) will present an update on the Company’s SADA technology platform at the Society of Nuclear Medicine and Molecular Imaging (“SNMMI”) Virtual Annual Meeting on July 14, 2020. The SADA technology was licensed by the Company from MSK and Massachusetts Institute of Technology (“MIT”) earlier this year.

Y-mAbs Announces Update on SADA Technology and New Preclinical SADA Construct

NEW YORK, June  30, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the Company has initiated the submission of its Biologics License Application (“BLA”) for omburtamab under the U.S. Food and Drug Administration’s (“FDA”) Rolling Review process. Omburtamab is an investigational, monoclonal antibody that targets B7-H3, an immune checkpoint molecule that is widely expressed in tumor cells of several cancer types. The omburtamab BLA is for the treatment of pediatric patients with CNS/leptomeningeal metastases from neuroblastoma.

Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA

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Y-mAbs Therapeutics, Inc. (YMAB) CEO Claus Moller on Q1 2020 Results - Earnings Call Transcript

NEW YORK, April  24, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc., (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced the Board of Directors (the “Board”) nominates healthcare executive Laura J. Hamill to be elected as a Class II director at the Company’s 2020 annual meeting of stockholders (the “Annual Meeting”).

Y-mAbs Announces Appointment of Laura J. Hamill to its Board of Directors

NEW YORK, April  15, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has entered into an agreement with Memorial Sloan Kettering Cancer Center (“MSK”) and Massachusetts Institute of Technology (“MIT”) for a worldwide exclusive license and research collaboration to develop and commercialize antibody constructs based on the SADA-BiDE (2-step Self-Assembly and DisAssembly-Bispecific DOTA-Engaging antibody system) Pre-targeted Radioimmunotherapy Platform (the “SADA technology”), a concept also referred to as Liquid RadiationTM.                                          

Y-mAbs enters into Worldwide Exclusive License Agreement for SADA Technology – a Novel Radioimmunotherapy Platform

Y-mAbs Therapeutics, Inc. (YMAB) CEO Claus Moller on Q4 2019 Results - Earnings Call Transcript

NEW YORK, Feb.  26, 2020  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer announced today that it has completed a positive Type B Pre-Biologics License Application (“Pre-BLA”) meeting with the U.S. Food and Drug Administration (“FDA”) regarding a potential pathway for FDA approval of omburtamab for the treatment of patients with CNS/leptomeningeal metastases from neuroblastoma.

Y-mAbs Announces Positive Pre-BLA Meeting with FDA for Omburtamab

NEW YORK, Dec.  12, 2019  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based and immunotherapeutic products for the treatment of cancer, today announced that its GD2-GD3 Vaccine has been granted a Rare Pediatric Disease Designation (“RPDD”) by the FDA for  the treatment of neuroblastoma.

Y-mAbs’ GD2-GD3 Vaccine Granted Rare Pediatric Disease Designation

NEW YORK, Dec.  05, 2019  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that the European Medicines Agency (“EMA”) has agreed to the Company’s proposed Pediatric Investigation Plan (“PIP”) for omburtamab. The decision was made on the basis of a positive opinion from EMA’s Pediatric Committee (“PDCO”). Omburtamab is being developed by Y-mAbs for the treatment of CNS/leptomeningeal metastases from neuroblastoma which is the indication targeted by the PIP, as well as a number of additional cancer indications.

Y-mAbs and the European Medicines Agency Pediatric Committee Reach Agreement on the Pediatric Investigation Plan for Omburtamab

NEW YORK, Nov.  29, 2019  (GLOBE NEWSWIRE) -- Y-mAbs Therapeutics, Inc. (the “Company” or “Y-mAbs”) (Nasdaq: YMAB), a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, today announced that it has submitted to the U.S. Food and Drug Administration (“FDA”) the first portions of its Biologics License Application (“BLA”) for naxitamab for the treatment of patients with relapsed/refractory high-risk neuroblastoma under the FDA’s Rolling Review process.

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