Welcome to our dedicated page for Day One Biopharmaceuticals news (Ticker: DAWN), a resource for investors and traders seeking the latest updates and insights on Day One Biopharmaceuticals stock.
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 its first quarter 2024 financial results and corporate progress, highlighting the launch of OJEMDA for pediatric low-grade glioma. The FDA accelerated approval of OJEMDA, the first therapy for pediatric patients with BRAF-altered pLGG. The company's cash position was $317.9 million. R&D expenses increased to $40.2 million, and G&A expenses rose to $26.6 million. Net loss was $62.4 million with upcoming events at ASCO, Goldman Sachs Conference, and ISPNO.
FAQ
What is the current stock price of Day One Biopharmaceuticals (DAWN)?
What is the market cap of Day One Biopharmaceuticals (DAWN)?
What is the primary focus of Day One Biopharmaceuticals?
What is tovorafenib (OJEMDA™)?
What recent milestone has Day One Biopharmaceuticals achieved?
What are the main clinical trials involving tovorafenib?
What designations has tovorafenib received from the FDA?
Where is Day One Biopharmaceuticals located?
What is the company’s approach to cancer treatment?
What other products are in Day One’s pipeline?
How does Day One Biopharmaceuticals support the pLGG community?
What impact does pLGG have on children?
