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 company pioneering targeted therapies for pediatric and adult cancers with genetic drivers. This page aggregates official press releases, regulatory filings, and verified news about DAWN's innovative oncology pipeline, including FDA-approved OJEMDA for pediatric low-grade glioma and investigational candidates like PTK7-targeting DAY301.
Investors and researchers will find updates on clinical trial progress, partnership announcements, and scientific developments. Content categories include earnings reports, research collaborations, regulatory milestones, and therapeutic pipeline advancements. All materials are sourced directly from company communications or reputable financial/medical publications.
Bookmark this page for structured access to DAWN's latest developments in precision oncology. Check regularly for updates on their mission to transform cancer treatment through genetically targeted therapies.
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.
SOUTH SAN FRANCISCO, Calif., Aug. 02, 2022 - Day One Biopharmaceuticals (Nasdaq: DAWN) will participate in a panel at the 2022 Wedbush PacGrow Healthcare Virtual Conference. The discussion, titled “Bullseye - Targeted Oncology - Finding Needles in Plain Sight,” is scheduled for August 9 at 10:55 a.m. ET. A live audio webcast of the event will be available on the company’s website, with an archived replay accessible for 30 days post-event. Day One is focused on developing therapies for pediatric cancer and aims to improve treatment options for patients of all ages.
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