Day One (DAWN) In-Licenses MabCare Cancer Candidate, Stock Up

Core Insights - Day One Biopharmaceuticals (DAWN) has signed an exclusive licensing agreement with MabCare Therapeutics for worldwide rights to develop, manufacture, and commercialize investigational candidate MTX-13 (now DAY301) for solid tumor indications, resulting in an 11.3% increase in shares on June 18 [1] - The FDA granted clearance for DAY301 in April 2024 based on positive pre-clinical study results, with plans to dose the first patient in a phase I study by late 2024 or early 2025 [2] - Year-to-date, Day One's shares have decreased by 8.3%, while the industry has seen a decline of 7.1% [3] Licensing Agreement Details - Day One will make an upfront payment of $55 million to MabCare for the rights to DAY301, excluding Greater China, and may pay up to $1.152 billion in milestone payments plus royalties on net sales outside Greater China upon product approval [16] Product Pipeline and Development - Ojemda, Day One's lead candidate, received FDA accelerated approval for treating pediatric patients with relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG) and is currently being launched commercially [9] - The company is also evaluating Ojemda in a pivotal late-stage study as a front-line therapy for patients aged six months to 25 years with pLGG, which could expand the eligible patient population [17] - DAY301 targets PTK7, a protein expressed in various adult and pediatric cancers, and is expected to leverage advanced linker-payload technology to overcome limitations of previous therapies [14][15] Market Position and Performance - Day One currently holds a Zacks Rank of 3 (Hold) [18] - The company’s clinical-stage pipeline includes another investigational candidate, pimasertib, which is being studied in combination with tovorafenib for MAPK-altered solid tumors [10]