Day One Biopharmaceuticals, Inc. ((DAWN)) announced an update on their ongoing clinical study.
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Day One Biopharmaceuticals, Inc. is conducting a Phase 2 study titled ‘FIREFLY-1’ to evaluate the safety and efficacy of the oral pan-RAF inhibitor DAY101, known as tovorafenib, in pediatric and young adult participants with relapsed or progressive low-grade glioma and advanced solid tumors. This study aims to address the unmet medical needs in these conditions by targeting RAF-altered tumors, potentially offering a new therapeutic option.
The intervention being tested is tovorafenib, an oral Type II RAF kinase inhibitor. It is administered weekly at a dose of 420 mg/m², tailored to the patient’s baseline body surface area. Tovorafenib is available in tablet form and as a powder for reconstitution.
The study is interventional, non-randomized, and follows a single-group assignment model with no masking. Its primary purpose is treatment, focusing on evaluating the drug’s impact on the specified conditions.
The study began on February 3, 2021, and is currently recruiting participants. The last update was submitted on March 27, 2025, indicating ongoing progress. These dates are crucial for tracking the study’s development and potential market entry.
This clinical update could positively impact Day One Biopharmaceuticals’ stock performance, as successful results may lead to a new treatment option for challenging pediatric cancers. Investors should monitor the study’s progress, considering the competitive landscape in oncology, where innovative therapies are highly sought after.
The study is ongoing, with further details available on the ClinicalTrials portal.