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Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with genetically defined cancers. Founded with a mission to address the significant unmet needs in pediatric cancer treatment, Day One's approach starts with the biology of childhood cancer to bring forward innovative therapies that benefit both children and adults.
The company’s lead product candidate, tovorafenib (OJEMDA™), is an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor. Tovorafenib targets a key enzyme in the MAPK signaling pathway and is currently under evaluation in two pivotal clinical trials for pediatric low-grade glioma (pLGG). The FDA has granted it Breakthrough Therapy and Rare Pediatric Disease designations for the treatment of patients with pLGG harboring an activating RAF alteration. On April 23, 2024, the FDA approved OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, marking a significant milestone for Day One.
Additionally, pLGG is the most common brain tumor diagnosed in children, accounting for 30% - 50% of all central nervous system tumors in this population. The absence of approved therapies for most pLGG patients underscores the chronic and relentless nature of the disease, which can significantly impact the long-term quality of life. Day One's FIREFLY-1 and FIREFLY-2/LOGGIC trials are evaluating tovorafenib in both relapsed and front-line settings, aiming to revolutionize the treatment landscape for these young patients.
Day One's robust pipeline also includes pimasertib, an investigational, oral, highly-selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2). The company is actively exploring additional clinical opportunities that leverage its innovative approach to cancer treatment.
With a dedicated team and strong partnerships with leading clinical oncologists, families, and scientists, Day One aims to continuously advance its mission. The company is headquartered in Brisbane, California, and remains committed to its vision of making a significant difference from Day One for all patients living with cancer.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced that three abstracts have been accepted for the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled for June 2-6, 2023. The company will present an oral session on new clinical data from the pivotal Phase 2 FIREFLY-1 trial of tovorafenib for recurrent pediatric low-grade glioma (pLGG). This presentation, led by Dr. Lindsay Kilburn, will take place on June 4, 2023. Additionally, two posters will showcase a phase 3 trial comparing tovorafenib with chemotherapy, and healthcare resource utilization data for pediatric low-grade glioma. To discuss these findings, Day One will host a conference call on June 4 at 6:00 PM CT. Tovorafenib, an investigational pan-RAF inhibitor, has received Breakthrough Therapy designation from the FDA for pLGG.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced a poster presentation at the 19th European Association of Dermato-Oncology Congress in Rome, Italy, from April 20-22, 2023.
Presentation Details:
- Title: Clinical Activity of the Type II pan-RAF Inhibitor Tovorafenib in BRAF-fusion Melanoma
- Format: Poster Presentation
- Poster Number: 174
- Session: Guided Poster Tour 2
- Date and Time: April 20, 8:45 – 9:30 AM ET
Tovorafenib is an investigational, oral pan-RAF kinase inhibitor, currently in clinical trials for pediatric and adult patients with relapsed solid tumors. It has received Breakthrough Therapy and Orphan Drug designations from the FDA for certain indications. Day One aims to address the unmet needs in pediatric cancer by developing targeted therapies.
Day One Biopharmaceuticals (Nasdaq: DAWN) has announced a major advancement in its clinical trials, dosing the first patient in the pivotal Phase 3 FIREFLY-2/LOGGIC trial for tovorafenib (DAY101) targeting pediatric low-grade glioma (pLGG). Following promising topline results from the Phase 2 FIREFLY-1 trial, the company plans to submit a New Drug Application (NDA) in the first half of 2023. Financially, Day One reported a net loss of $40.1 million for Q4 2022 and $142.2 million for the year, with R&D expenses significantly increasing. The company ended 2022 with $342.3 million in cash, ensuring operational funding into 2025.
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