On December 28, 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, reported that it has entered into a definitive agreement to sell its Priority Review Voucher ("PRV") to United Therapeutics Corporation (Nasdaq: UTHR), based on an agreed valuation of $105 million (Press release, Y-mAbs Therapeutics, DEC 28, 2020, View Source [SID1234573288]).
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The PRV was granted in conjunction with the approval by the U.S. Food and Drug Administration ("FDA") of DANYELZA, for the treatment of refractory/relapsed high-risk neuroblastoma.
Under the terms of the Company’s license agreement with Memorial Sloan Kettering Cancer Center ("MSK"), Y-mAbs is entitled to retain 60% of the net proceeds from monetization of the PRV, and the remaining 40% will be paid to MSK. The transaction remains subject to customary closing conditions, including anti-trust review.
"We are pleased to announce the sale of the PRV, which will provide an important source of non-dilutive capital to fund additional investment in our pipeline. These efforts will be critical to our growth over the coming year, and we are committed to our mission of becoming a world leader in developing better and safer antibody-based oncology products addressing unmet pediatric and adult medical needs," said Thomas Gad, founder, Chairman and President.
Jefferies LLC acted as exclusive financial advisor to Y-mAbs on this transaction.
Researchers at MSK developed DANYELZA, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests related to the compound and Y-mAbs.
About DANYELZA (naxitamab-gqgk)
DANYELZA (naxitamab-gqgk) 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 was approved under accelerated approval 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 includes a Boxed Warning for serious infusion-related reactions, such as cardiac arrest and anaphylaxis, and neurotoxicity, such as severe neuropathic pain and transverse myelitis. See full Prescribing Information for complete Boxed Warning and other important safety information.