Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) is engaged as a clinical-stage biopharmaceutical company, which is focused on the research, development and commercialization of treatments for different types of pediatric cancers. Shares of the biopharma company are skyrocketing 123% through early trading on Monday, June 13, 2022. Over the past three months, Day One Biopharmaceuticals has seen average daily volume of 186,530 shares. However, volume of 29.85 million shares or dollar volume of around $405.06 million, has already exchanged hands through early trading.
Shares of Day One Biopharmaceuticals are surging after the company announced positive initial results from its FIREFLY-1 clinical trial of tovorafebib (DAY101) and the treatment of pediatric low-grade glioma (pLGG). From the first 22 Response Assessment for Neuro-Oncology (RANO)-evaluable patients in the Phase 2 clinical trial, tovorafebub demonstrated an overall response rate (ORR) of 64% and a clinical benefit rate (CBR) of 91%.
The biopharma company reported 14 partial responses and six patients with stable disease. All patients that were rated with stable disease saw a tumor shrinkage between 19% and 43%. The median-time-to-response was 2.8 months in a heavily-pretreated clinical population. All patients who responded from treatment are continuing therapy and there have been no discontinuations due to adverse events from treatment.
The DAY101 candidate was given as a one-weekly monotherapy in patients ranging in age from 6 months to 25 years with relapsed or progressive pLGG, which is the most common form of brain cancer found in children. There are currently no approved therapies and no standard of care for treating pLGG.
Day One Biopharmaceuticals estimates topline results from the full FIREFLY-1 clinical trial to be completed during the first quarter of 2023. The company plans to move to a pivotal Phase 3 clinical trial sometime during the third quarter of 2023.
“These initial findings underscore the potential of tovorafenib monotherapy to become a significant and transformative new option for relapsed/progressive pLGG, a pediatric brain tumor with no approved treatments today,” said Samuel Blackman, M.D., Ph.D., co-founder and chief medical officer of Day One. “With the registrational cohort fully enrolled, patient follow-up is ongoing, and we look forward to the topline data from the complete study population in the first quarter of 2023. Based on these positive initial data, we plan to begin the pivotal Phase 3 FIREFLY-2 clinical trial evaluating tovorafenib as a front-line therapy in pLGG to evaluate whether tovorafenib can provide benefit early in the disease development.”
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