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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) has commenced dosing the first patient in a Phase 2 clinical trial evaluating DAY101 as a monotherapy for patients with RAF-altered solid tumors. DAY101 is a pan-RAF kinase inhibitor targeting the MAPK pathway. The multi-center study, FIRELIGHT-1, aims to assess the safety and efficacy of DAY101 with an overall response rate as the primary endpoint. Day One plans to initiate a Phase 1b combination study with its MEK inhibitor, pimasertib, in Q1 2022, while continuing to gather data from a pivotal trial in pediatric low-grade glioma patients.
Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company, announced its participation in a fireside chat at the Piper Sandler 33rd Annual Virtual Healthcare Conference. Management will engage in a pre-recorded discussion, available on November 22 at 10:00 a.m. ET. This talk highlights Day One's mission to develop targeted cancer therapies, particularly for pediatric patients. The company’s lead product candidate, DAY101, is currently in a pivotal clinical trial for low-grade glioma. Access the webcasts via the Company's website.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported significant progress in their pivotal Phase 2 FIREFLY-1 trial for DAY101, targeting pediatric low-grade glioma (pLGG). In Q3 2021, they secured Rare Pediatric Disease Designation and strengthened their leadership team. Financial highlights include cash reserves of $297.2 million, allowing operations to continue into H2 2023. R&D and G&A expenses surged to $9.8 million and $9.4 million, respectively, resulting in a net loss of $19.2 million for Q3 2021. Initial clinical data is anticipated in H1 2022.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported a complete response in a pediatric patient with recurrent spindle cell sarcoma treated with DAY101 monotherapy, demonstrating its potential efficacy. This case will be presented at the 2021 Connective Tissue Oncology Society (CTOS) Virtual Annual Meeting from November 10-13, 2021. DAY101, a type II pan-RAF inhibitor, targets key enzymes in the MAPK pathway and has shown good tolerability and encouraging activity in over 250 patients. The FDA has granted Breakthrough Therapy and Rare Pediatric Disease Designation for DAY101.
Day One Biopharmaceuticals (NASDAQ: DAWN) appointed Jaa Roberson as chief people officer to oversee human resources and talent acquisition. Roberson, with 20 years of HR experience in biopharma and health insurance, aims to contribute to the company's growth in targeted cancer therapies. CEO Jeremy Bender expressed confidence in her leadership, aligning with Day One’s mission to address critical unmet needs in cancer drug development, particularly for children. The firm is currently evaluating DAY101 in a pivotal Phase 2 clinical trial for low-grade glioma.
Day One Biopharmaceuticals (Nasdaq: DAWN) has appointed Scott Garland to its board of directors, enhancing its leadership team as it advances its pivotal Phase 2 FIREFLY-1 clinical trial of DAY101 in pediatric patients with progressive low-grade glioma. Garland brings over 30 years of biopharmaceutical experience, having successfully launched multiple therapies. DAY101, an investigational pan-RAF kinase inhibitor, has shown promising results in early trials, including good tolerability and anti-tumor activity. It is designed to target certain cancers, particularly in children.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported significant advancements in the second quarter of 2021. The FDA has granted Rare Pediatric Disease Designation and the European Commission has awarded Orphan Designation for DAY101, aimed at treating low-grade gliomas. The company successfully dosed the first patients in the pivotal FIREFLY-1 trial. Furthermore, Day One raised $184 million in its initial public offering, ensuring funding into the second half of 2023. As of June 30, 2021, cash and equivalents stood at $310 million, supporting their ambitious clinical pipeline.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced that CEO Dr. Jeremy Bender will participate in a panel discussion titled “Bullseye – Targeted Oncology Part 2” at the 12th Annual Wedbush PacGrow Healthcare Conference, scheduled for August 10-11, 2021. Dr. Bender's presentation is set for August 11 at 10:20 a.m. ET. The event will be held virtually, with webcasts available for live and archived viewing on the company's website. Day One is focused on developing targeted therapies for genomically defined cancers, especially for children.
Day One Biopharmaceuticals (Nasdaq: DAWN) has received Rare Pediatric Disease Designation from the FDA for its lead product DAY101, aimed at treating low-grade gliomas in children with RAF alterations. This designation highlights the urgent need for effective therapies for pediatric low-grade gliomas (pLGG), which currently have no approved treatments. DAY101 is a type II pan-RAF inhibitor and is now part of the pivotal Phase 2 FIREFLY-1 clinical trial. If DAY101 is approved, Day One may receive a Priority Review Voucher from the FDA.
Day One Biopharmaceuticals announced that the European Commission granted orphan designation for its lead product candidate, DAY101, to treat glioma. This decision follows a positive opinion from the European Medicines Agency. DAY101, an oral pan-RAF kinase inhibitor, is under pivotal Phase 2 trial (FIREFLY-1) for pediatric patients with low-grade glioma exhibiting known BRAF alterations. The orphan designation provides benefits like reduced regulatory fees and potential market exclusivity. Currently, there are no approved therapies for pediatric low-grade glioma.
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