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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), a clinical-stage biopharmaceutical company focused on pediatric cancer treatments, announced its participation in the Cowen 43rd Annual Health Care Conference on March 7, 2023, at 9:10 a.m. ET. The company aims to address unmet needs in pediatric cancer therapy with its lead product candidate, tovorafenib (DAY101), a targeted oral treatment. Additionally, an archived webcast will be accessible for 30 days following the event. Day One is dedicated to redefining cancer drug development for all ages from the first day of diagnosis.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced positive topline results from the Phase 2 FIREFLY-1 trial of tovorafenib (DAY101) for pediatric low-grade glioma (pLGG). Of 69 RANO-evaluable patients, the overall response rate (ORR) was 64%, with a clinical benefit rate of 91%. The median treatment duration was 8.4 months, and 77% of patients remained on therapy. A New Drug Application is planned for the first half of 2023, with additional data to be presented in Q2 2023. Tovorafenib has shown safety and tolerability, with common side effects including hair color change and anemia.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced that CEO Dr. Jeremy Bender will present at the 41st Annual J.P. Morgan Healthcare Conference on January 9 at 4:30 p.m. PT / 7:30 p.m. ET. A live audio webcast will be accessible on the Company's website, with a replay available for 30 days post-event.
Day One focuses on developing targeted therapies for pediatric cancer, addressing unmet medical needs. Their lead candidate, tovorafenib (DAY101), is a selective pan-RAF kinase inhibitor, complemented by pimasertib, a MEK-1/-2 inhibitor.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced participation in a fireside chat at the Piper Sandler 34th Annual Healthcare Conference on November 29, 2022, at 11:00 a.m. EST. The discussion aims to showcase the company's commitment to developing targeted therapies for pediatric cancer. A live audio webcast will be accessible on the company’s website, with an archived version available for 30 days post-event. Day One focuses on addressing critical needs in pediatric cancer treatment, exemplified by their investigational drug candidates, tovorafenib (DAY101) and pimasertib.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced two upcoming poster presentations at the Society for Neuro-Oncology annual meeting in Tampa, FL, from November 16-20, 2022. The presentations focus on the investigational drug Tovorafenib, aimed at treating pediatric and young adult patients with low-grade glioma. The Phase 2 study (FIREFLY-1) and Phase 3 trial (FIREFLY-2) will be presented on November 18, 2022. Tovorafenib targets a key enzyme in the MAPK signaling pathway and has received Breakthrough Therapy designation from the FDA.
Day One Biopharmaceuticals (NASDAQ: DAWN) reported third-quarter 2022 financial results, showing a net loss of $37.8 million compared to $19.2 million in Q3 2021. The company's cash position was strong at $374.3 million, expected to fund operations into 2025. Positive interim results from the pivotal FIREFLY-1 study of tovorafenib in relapsed pediatric low-grade glioma (pLGG) have been announced. Upcoming milestones include topline results from FIREFLY-1 in Q1 2023 and potential NDA submission to the FDA.
Day One Biopharmaceuticals (NASDAQ: DAWN) announced a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute to enhance research on tovorafenib (DAY101), a selective pan-RAF kinase inhibitor. This agreement allows NCI investigators to explore tovorafenib's efficacy in various cancers, building upon its positive initial data from a Phase 2 trial for treating pediatric low-grade glioma (pLGG). The company emphasizes its commitment to developing treatments for pediatric cancers and has additional trials planned for both pediatric and adult populations.
Day One Biopharmaceuticals (NASDAQ: DAWN) announced a collaboration with Foundation Medicine to develop FoundationOne CDx as a companion diagnostic for its investigational therapy, tovorafenib (DAY101), targeting pediatric low-grade glioma. Tovorafenib is currently in pivotal Phase 2 trials, with topline results expected in Q1 2023. The partnership aims to improve patient access to tovorafenib and enhance treatment precision for pediatric cancers. If approved, this will mark FoundationOne CDx's first companion diagnostic use in pediatric oncology.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced the appointment of Garry Nicholson as chairman of its board, bringing over 30 years of oncology experience from Pfizer Oncology. Previously chaired by co-founder Julie Grant, Nicholson's leadership is expected to be crucial as tovorafenib advances in its pivotal FIREFLY-1 trial for relapsed pediatric low-grade glioma. Tovorafenib, an investigational pan-RAF kinase inhibitor, is under evaluation in several trials and has received Breakthrough Therapy designation from the FDA. The company aims to improve therapeutic options for pediatric cancer patients.
Day One Biopharmaceuticals (DAWN) reported promising initial data from its pivotal FIREFLY-1 study on tovorafenib (DAY101) for pediatric low-grade glioma, showing a 64% overall response rate and 91% clinical benefit rate among 22 evaluable patients. Additionally, the company raised $172.5 million through a public offering, ensuring funding into 2025. Day One's pipeline expands with the initiation of the FIREFLY-2/LOGGIC trial, evaluating the drug as a front-line treatment. The company anticipates topline results from FIREFLY-1 in Q1 2023 and plans to file for FDA approval thereafter.
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