NEW YORK - Y-mAbs Therapeutics, Inc. (NASDAQ:YMAB), a commercial-stage biopharmaceutical company, has partnered with Nobelpharma Co., Ltd. to bring DANYELZA, a treatment for high-risk neuroblastoma, to Japan. The exclusive license and distribution agreement announced today details that Nobelpharma will lead the development, regulatory submissions, and potential commercialization of DANYELZA in Japan.
Under the agreement, Y-mAbs receives an upfront payment of $2 million and may earn up to $31 million in milestone payments, along with profit sharing on Japanese sales if DANYELZA is approved and commercialized. This deal marks a significant move in Y-mAbs' strategy to expand its global presence.
DANYELZA (naxitamab-gqgk) is currently indicated in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF) for certain pediatric and adult patients with relapsed or refractory high-risk neuroblastoma. The therapy was developed by researchers at Memorial Sloan Kettering Cancer Center (MSK) and is licensed to Y-mAbs. MSK holds a financial interest in the compound and Y-mAbs.
Michael Rossi, President and CEO of Y-mAbs, expressed optimism about the partnership's potential to impact patients in Japan. Thomas Gad, Founder and Chief Business Officer, echoed this sentiment, highlighting the opportunity to provide a new therapeutic option for treating pediatric cancer.
However, it is important to note that DANYELZA's approval for relapsed/refractory high-risk neuroblastoma in Japan is not yet secured, and its use for osteosarcoma remains unapproved. The forward-looking statements included in the press release reflect the company's hopes rather than guaranteed outcomes.
The financial details of the agreement and the potential benefits for patients are based on a press release statement from Y-mAbs Therapeutics, Inc. and have not been independently verified. The success of this partnership will depend on the regulatory approval process in Japan and the subsequent market acceptance of DANYELZA, should it become available.
In other recent news, Y-mAbs Therapeutics has resolved a legal dispute over director compensation and cancelled 5,000 stock options granted to its non-employee directors for 2020 and 2021. This resolution follows allegations of excessive compensation and inadequate disclosures regarding the peer group used to set director compensation. Y-mAbs Therapeutics also signed a new headquarters lease in Princeton, New Jersey, securing approximately 10,817 square feet of space.
In the financial arena, Y-mAbs reported a 10% increase in total DANYELZA net product revenue to $22.8 million in its second-quarter earnings for 2024, despite a 4% drop in US DANYELZA revenue. Analysts from Cantor Fitzgerald initiated coverage on Y-mAbs, providing an Overweight rating and a price target of $20.00, while BMO Capital Markets adjusted its price target for Y-mAbs to $25.00, maintaining an Outperform rating.
On the clinical front, Y-mAbs announced new data for its therapies naxitamab and GD2-SADA in neuroblastoma, with the interim analysis from Trial 201 showing a 63% disease control rate in patients with high-risk neuroblastoma. These are recent developments in the company's ongoing efforts to improve patient outcomes through innovative cancer treatments.
InvestingPro Insights
Y-mAbs Therapeutics' recent partnership with Nobelpharma for DANYELZA in Japan aligns with the company's strong financial position and growth potential. According to InvestingPro data, Y-mAbs boasts impressive gross profit margins of 88.62% for the last twelve months as of Q2 2024, indicating efficient cost management in its core operations. This financial strength could support the company's expansion efforts and potential milestone achievements from the Nobelpharma deal.
An InvestingPro Tip highlights that Y-mAbs holds more cash than debt on its balance sheet, which provides financial flexibility to pursue strategic initiatives like the Japanese market entry. Additionally, the company's liquid assets exceed short-term obligations, suggesting a solid foundation for funding the DANYELZA development and commercialization process in Japan.
Despite these positive indicators, investors should note that Y-mAbs is not currently profitable, with a negative P/E ratio of -26.69. However, the company's strong year-to-date price total return of 116.13% reflects market optimism about its future prospects, potentially including the success of partnerships like the one with Nobelpharma.
For a more comprehensive analysis, InvestingPro offers 7 additional tips that could provide valuable insights into Y-mAbs' financial health and market position.
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