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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 announced a public offering of $125 million in common stock, with an additional $18.75 million possible if underwriters exercise their overallotment option. The offering, managed by J.P. Morgan, Cowen, and Piper Sandler, is subject to market conditions. The securities are registered under an SEC declaration. Proceeds from this offering will potentially support the development of therapies for pediatric cancer, as Day One aims to address the unmet needs in this critical area.
Day One Biopharmaceuticals (NASDAQ: DAWN) announced promising initial results from the Phase 2 FIREFLY-1 trial of tovorafenib in pediatric low-grade glioma (pLGG). The trial showed an overall response rate (ORR) of 64% and a clinical benefit rate (CBR) of 91% in 22 evaluable patients, with 14 achieving partial response. Tovorafenib, a selective pan-RAF kinase inhibitor, is undergoing further evaluation, with topline results expected in Q1 2023 and plans for a pivotal Phase 3 trial starting in Q3 2022. These findings suggest a potential new treatment option in a disease with no approved therapies.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced the first patient dosing in sub-study 2 of the Phase 1b/2 clinical trial FIRELIGHT-1. This study evaluates the combination of tovorafenib (DAY101), a selective pan-RAF kinase inhibitor, and pimasertib, a MEK-1/-2 inhibitor, in adolescents and adults with recurrent solid tumors featuring MAPK pathway alterations. The trial aims to assess safety and efficacy, building on preclinical data indicating potential synergistic effects between the two drugs. Tovorafenib has received FDA's Breakthrough Therapy and Rare Pediatric Disease designations.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced its first-quarter 2022 financial results and provided updates on clinical programs. The company expects initial data from the pivotal FIREFLY-1 trial for tovorafenib in pediatric low-grade glioma in June 2022. Day One plans to initiate the Phase 3 FIREFLY-2 trial in Q2 2022 and has launched a Phase 1b/2 study combining tovorafenib with pimasertib. Financial highlights include cash reserves of $262.7 million, a net loss of $27.7 million for Q1 2022, and increased R&D and G&A expenses.
Day One Biopharmaceuticals (Nasdaq: DAWN) will present at the 21st Annual Needham Virtual Healthcare Conference on April 13 at 3:45 p.m. ET. The event provides an opportunity for management to discuss the company's advancements in developing targeted therapies for life-threatening diseases, particularly pediatric cancer. A live audio webcast of the presentation will be accessible via the company's website, with an archived replay available for 30 days post-event.
Founded to address unmet needs in pediatric cancer treatment, Day One focuses on innovative cancer drug development.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported its fourth quarter and full year 2021 financial results on March 7, 2022, highlighting significant clinical milestones and financial metrics. The company expects initial data from its pivotal FIREFLY-1 study on DAY101 in pediatric low-grade glioma by June 2022, with topline results anticipated in Q1 2023. With cash reserves of $284.3 million as of December 31, 2021, Day One is well-positioned to fund operations into 2024. R&D expenses rose to $43.6 million for 2021, reflecting investment in clinical trials. Net losses for the year were $72.8 million.
Day One Biopharmaceuticals (Nasdaq: DAWN), a clinical-stage biopharmaceutical company, has announced its participation in a fireside chat at the Cowen 42nd Annual Health Care Conference on March 7 at 2:50 p.m. ET. A live audio webcast of the chat will be accessible on the company’s website, with a replay available for 30 days.
The company specializes in targeted therapies for life-threatening diseases, highlighting its lead product candidate, DAY101, which is currently in a pivotal Phase 2 trial for low-grade glioma in younger patients.
On January 5, 2022, Day One Biopharmaceuticals (Nasdaq: DAWN) announced that CEO Dr. Jeremy Bender will present at the 40th Annual J.P. Morgan Healthcare Conference on January 11 at 10:30 a.m. ET. The presentation will be accessible via a live audio webcast on the company's website, with a replay available for 30 days afterwards. Day One is focused on developing targeted therapies for life-threatening diseases, including its lead candidate DAY101, currently in a pivotal Phase 2 trial for pediatric low-grade glioma.
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.
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