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Y-mAbs Therapeutics Inc (YMAB)

  • Event
  • July 12, 2022, 13:20 UTC

(10% Negative) Y-MABS THERAPEUTICS, INC. (YMAB) Announces Delay in included Trials for GD2-SADA New York Due to Pandemic-Related Challenges, Regulatory Process, Manufacturing Considerations, Safety Review, Efficacy Assessment

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  • News bot Oct. 2, 2025, 12:53 p.m.

    📋 Y-MABS THERAPEUTICS, INC. (YMAB) - Clinical Trial Update

    Filing Date: 2022-07-12

    Accepted: 2022-07-12 09:20:40

    Event Type: Clinical Trial Update

    Event Details:

    Y-mAbs Therapeutics Inc (YMAB) Announces Clinical Trial Update Y-mAbs Therapeutics Inc (YMAB) provided an update on its clinical development programs. Clinical Development Highlights:
    • Drug Program: included, assemble
    • Diseases/Conditions: GD2-SADA New York, GD2-SADA marks an important milestone toward
    • Clinical Stage: clinical trial, Phase 1
    • Update Type: Trial Timeline Adjustment
    • Primary Factors: Pandemic-Related Challenges, Regulatory Process
    • Collaboration: Memorial Sloan Kettering Cancer Center
      • targeting tumors with precision while minimizing radiation of normal tissues. We believe that the SADA technology platform can deliver a variety of payloads and could potentially be developed against multiple tumor targets, as well as for theragnostic purposes. “The FDA acceptance of the IND for GD2-SADA marks an important milestone towards our mission of developing novel SADA treatments as we continue to execute our clinical development strategy for our pipeline of SADA constructs for the treatment of cancers with unmet medical need,” said Thomas Gad, founder, President and Interim CEO. “We are seeing significant partnership interest for the SADA technology and we believe we are well-positioned to leverage the SADA platform as we move forward. We are truly excited about the potential of the SADA technology, which has already shown great promise, and we believe that it can further unlock the potential of radiolabeled therapeutics in tumors that have not historically demonstrated meaningful responses to radiolabeled agents.” Researchers at MSK, including Dr. Cheung, developed the SADA technology for radioimmunotherapy, which is exclusively licensed by MSK to Y-mAbs. Dr. Cheung has intellectual property rights and interests in the technology, and as a result of this licensing arrangement, MSK has institutional financial interests in the technology and in Y-mAbs. About Y-mAbs Y-mAbs is a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic cancer products. In addition to conventional antibodies, the Company’s technologies include bispecific antibodies generated using the Y-BiClone platform, and the SADA platform. The Company’s broad and advanced product pipeline includes one FDA-approved product, DANYELZA® (naxitamab-gqgk), which targets tumors that express GD2, and one product candidate at the registration-stage, OMBLASTYS® (omburtamab), which targets tumors that express B7-H3. Forward-Looking Statements Statements in this press release about future expectations, plans and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements” within the meaning of The Private Securities Litigation Reform Act of 1995

    💼 Business Developments:

    • Partnership
    • Acquisition: Not available
    • Licensing
    • Regulatory Approval
    • Executive Changes: Not available

    Structured Data:

    • Company Name: Y-mAbs Therapeutics Inc
    • CIK: 0001722964
    • Ticker Symbol: YMAB
    • Period End Date: 2022-07-12
    • Document Type: 8-K

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