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 that three abstracts have been accepted for the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, scheduled for June 2-6, 2023. The company will present an oral session on new clinical data from the pivotal Phase 2 FIREFLY-1 trial of tovorafenib for recurrent pediatric low-grade glioma (pLGG). This presentation, led by Dr. Lindsay Kilburn, will take place on June 4, 2023. Additionally, two posters will showcase a phase 3 trial comparing tovorafenib with chemotherapy, and healthcare resource utilization data for pediatric low-grade glioma. To discuss these findings, Day One will host a conference call on June 4 at 6:00 PM CT. Tovorafenib, an investigational pan-RAF inhibitor, has received Breakthrough Therapy designation from the FDA for pLGG.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced a poster presentation at the 19th European Association of Dermato-Oncology Congress in Rome, Italy, from April 20-22, 2023.
Presentation Details:
- Title: Clinical Activity of the Type II pan-RAF Inhibitor Tovorafenib in BRAF-fusion Melanoma
- Format: Poster Presentation
- Poster Number: 174
- Session: Guided Poster Tour 2
- Date and Time: April 20, 8:45 – 9:30 AM ET
Tovorafenib is an investigational, oral pan-RAF kinase inhibitor, currently in clinical trials for pediatric and adult patients with relapsed solid tumors. It has received Breakthrough Therapy and Orphan Drug designations from the FDA for certain indications. Day One aims to address the unmet needs in pediatric cancer by developing targeted therapies.
Day One Biopharmaceuticals (Nasdaq: DAWN) has announced a major advancement in its clinical trials, dosing the first patient in the pivotal Phase 3 FIREFLY-2/LOGGIC trial for tovorafenib (DAY101) targeting pediatric low-grade glioma (pLGG). Following promising topline results from the Phase 2 FIREFLY-1 trial, the company plans to submit a New Drug Application (NDA) in the first half of 2023. Financially, Day One reported a net loss of $40.1 million for Q4 2022 and $142.2 million for the year, with R&D expenses significantly increasing. The company ended 2022 with $342.3 million in cash, ensuring operational funding into 2025.
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.
