Y-mAbs Therapeutics Inc.
750 Third Avenue, 9th Floor
New York
New York
10017
United States
Tel: 212-847-9841
Website: http://www.ymabs.com/
Email: info@ymabs.com
About Y-mAbs Therapeutics Inc.
YmAbs is a clinical stage biopharmaceutical company focused on developing new cancer treatments through immunotherapies. In addition, YmAbs utilizes its platform technologies to create next-generation humanized, affinity matured bispecific antibodies targeting GD2 and B7-H3. To further improve our bispecific antibodies, we are collaborating with MSK on the development of a novel human protein tag that dimerizes T-cell engaging bispecific antibodies, which enables higher tumor binding and results in a longer serum half-life and a significantly greater T-cell mediated killing of tumor cells. Our treatments could potentially reduce longer-term toxicities associated with current chemotherapeutics and provide the potential for curative therapy even for patients with widespread disease. YmAbs’ goal is to drive multiple product candidates in select solid tumor cancers to FDA licensure. Each candidate has the potential to treat a variety of high-risk cancers.YEAR FOUNDED:
April 2014
LEADERSHIP:
Founder, President and Head of Business Development and Strategy: Thomas Gad
CEO: Claus Moller
CFO: Bo Kruse
SVP, Head of Technical Operations: Torben Lund-Hansen, PhD
SVP, CMO: Ole Baadsgaard, MD, DMSc
CAREER:
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131 articles about Y-mAbs Therapeutics Inc.
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The FDA uses special designations to get new, breakthrough treatments to patients in the greatest need.
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The end of November and beginning of December is marked by several PDUFA dates at the U.S. Food and Drug Administration (FDA). Here’s a look.
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FDA Approves Y-mAbs’ DANYELZA® (naxitamab-gqgk) for the Treatment of Neuroblastoma
11/26/2020
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-CS
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Y-mAbs Announces Update on Omburtamab in DIPG
11/19/2020
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”).
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Y-mAbs Announces Third Quarter 2020 Financial Results and Recent Corporate Developments
11/5/2020
Y-mAbs Therapeutics, Inc. a development-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the third quarter 2020.
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Y-mAbs to Announce Third Quarter 2020 Financial and Operating Results on November 5, 2020
10/29/2020
Y-mAbs Therapeutics, Inc. announced that it will report its financial results for the third quarter ended September 30, 2020 on Thursday, November 5, 2020, after the close of the U.S. financial markets.
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Y-mAbs Announces FDA Clearance of IND for Lutetium-177 Labeled Omburtamab Antibody for Adult Indications
10/26/2020
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 177 Lu-omburtamab-DTPA for the treatment of B7-H3 positive Central Nerv
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Y-mAbs Announces Update on Naxitamab and Omburtamab in Neuroblastoma
10/16/2020
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 Interna
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Y-mAbs Announces FDA Clearance of IND for its Lutetium-177 Labeled Omburtamab Antibody
10/14/2020
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
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Y-mAbs’ Nivatrotamab for the Treatment of Patients with Neuroblastoma Granted Orphan Drug Designation and Rare Pediatric Disease Designation by FDA
10/7/2020
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.
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Y-mAbs Provides Regulatory Update on Omburtamab for the Treatment of Patients with Neuroblastoma
10/5/2020
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 Y-mAbs has received a Refusal to File letter from the U.S. Food and Drug Administration (“FDA”) regarding the Biologics License Application (“BLA”) for omburtamab
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Y-mAbs Announces Second Quarter 2020 Financial Results and Recent Corporate Developments
8/6/2020
Y-mAbs Therapeutics, Inc. a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the second quarter 2020.
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Y-mAbs Announces Completion of Submission of Omburtamab Biologics License Application to FDA
8/6/2020
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, m
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Y-mAbs to Announce Second Quarter 2020 Financial and Operating Results on August 6, 2020
8/4/2020
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, Ch
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Y-mAbs Announces Data to be Presented at 2020 SIOP
7/27/2020
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.
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Y-mAbs Announces Update on SADA Technology and New Preclinical SADA Construct
7/14/2020
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”)
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Y-mAbs Announces Initiation of Submission of Omburtamab Rolling Biologics License Application to the FDA
6/30/2020
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.
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Y-mAbs Announces U.S. FDA Acceptance of Biologics License Application for Danyelza™ (naxitamab) for the Treatment of Neuroblastoma for Priority Review
6/2/2020
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 Biologics License Application (“BLA”) for Danyelza™
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Y-mAbs Announces Data to be Presented at 2020 ASCO Annual Meeting
5/13/2020
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 two poster presentations at the American Society of Clinical Oncology (“ASCO”) Virtual Annual Meeting, taking place virtually from May 29, 2020 to June 2, 2020. The presentat
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Y-mAbs Announces First Quarter 2020 Financial Results and Recent Corporate Developments
5/7/2020
Y-mAbs Therapeutics, Inc. a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported financial results for the first quarter 2020.