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Day One Biopharmaceuticals, Inc. - $DAWN STOCK NEWS

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.

Our selection of high-quality news articles is accompanied by an expert summary from Rhea-AI, detailing the impact and sentiment surrounding the news at the time of release, providing a deeper understanding of how each news could potentially affect Day One Biopharmaceuticals's stock performance. The page also features a concise end-of-day stock performance summary, highlighting the actual market reaction to each news event. The list of tags makes it easy to classify and navigate through different types of news, whether you're interested in earnings reports, stock offerings, stock splits, clinical trials, fda approvals, dividends or buybacks.

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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.

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2.89%
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Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) announced the US FDA accelerated approval of OJEMDA™ (tovorafenib) for relapsed or refractory BRAF-altered pediatric low-grade glioma (pLGG), the most common childhood brain tumor. OJEMDA is the first FDA-approved type II RAF inhibitor for patients with BRAF alterations, boasting an overall response rate of 51%. The approval came with a rare pediatric disease priority review voucher. OJEMDA provides hope for children with BRAF-driven pLGG, offering a new treatment option with once-weekly oral dosing. The approval was based on data from the pivotal Phase 2 FIREFLY-1 trial, showcasing promising results in efficacy and safety.
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Day One Biopharmaceuticals (DAWN) announced its fourth quarter and full year 2023 financial results, with a cash position of $366.3 million, Phase 2 FIREFLY-1 registrational data published in Nature Medicine, and upcoming PDUFA target action date for tovorafenib NDA set for April 30, 2024.
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Day One Biopharmaceuticals (DAWN) announced the appointments of Habib Dable and Dr. William Grossman to its Board of Directors. Both bring extensive experience in the healthcare industry and oncology, which will strengthen the company's board as they prepare for the potential launch of their first new medicine.
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-0.86%
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Day One Biopharmaceuticals (Nasdaq: DAWN) announced that Dr. Jeremy Bender, CEO, will present at the 42nd Annual J.P. Morgan Healthcare Conference on January 8. A live webcast will be available on the company's website.
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Day One Biopharmaceuticals (Nasdaq: DAWN) announced the publication of the registrational Phase 2 FIREFLY-1 trial results evaluating the investigational agent tovorafenib in patients with BRAF-altered, relapsed or progressive pediatric low-grade glioma (pLGG) in Nature Medicine. Subsets of the data will also be presented today in two oral plenary presentations at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting in Vancouver, Canada. The study results demonstrate promising evidence with respect to the impact of tovorafenib for children and young adults with BRAF-altered relapsed or progressive pLGG, a debilitating form of brain tumor that currently has no approved systemic therapies. The Phase 3 FIREFLY-2/LOGGIC randomized clinical trial is also evaluating tovorafenib frontline therapy for patients newly diagnosed with pLGG.
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Day One Biopharmaceuticals (Nasdaq: DAWN) will participate in a fireside chat at the Piper Sandler 35th Annual Healthcare Conference on November 28 at 11:30 a.m. EST. A live audio webcast of the discussion will be available on the Company’s website, with an archived replay for 30 days.
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6.85%
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Day One Biopharmaceuticals announced that the FDA has accepted the New Drug Application (NDA) for tovorafenib in relapsed or progressive pediatric low-grade glioma (pLGG) for Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for April 30, 2024. Day One also highlighted recent corporate achievements and financial results for the third quarter of 2023.
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Day One Biopharmaceuticals has announced that the FDA has accepted its New Drug Application for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted priority review and set a target action date of April 30, 2024. pLGG is the most common brain tumor in children with no approved therapy. The NDA is based on results from a Phase 2 trial, and the company may receive a priority review voucher.
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Day One Biopharmaceuticals submits NDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG)
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Day One Biopharmaceuticals, Inc.

Nasdaq:DAWN

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DAWN Stock Data

1.43B
54.60M
19.7%
89.21%
10.28%
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United States of America
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About DAWN

day one biopharmaceuticals understands that advances in cancer research now enable drug developers to identify children and adults who may benefit from the same medicine. we are a unique company created to find and develop new therapies that meet the critical needs of people of all ages living with cancer – starting from the biology of childhood cancer. our distinctive approach, together with our trusted network of pediatric oncology investigators, gives us an unparalleled ability to advance promising discoveries for patients of any age. we are ready to pursue the full potential of our therapies to improve the greatest number of lives as quickly as possible.