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.
The Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) news page on Stock Titan aggregates company announcements, clinical updates, financial results, and corporate developments for this commercial-stage oncology biopharmaceutical company. Day One describes itself as dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, with a strong emphasis on pediatric cancer and rare cancers.
Investors and followers of DAWN can use this news feed to review updates on OJEMDA™ (tovorafenib), Day One’s Type II RAF kinase inhibitor indicated for certain BRAF-altered pediatric low-grade gliomas. Company press releases cover pivotal and follow-up data from the FIREFLY-1 Phase 2 trial, the ongoing FIREFLY-2/LOGGIC Phase 3 trial in front-line pLGG, and regulatory designations such as Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug status described in Day One’s communications.
The feed also captures financial results and guidance, including OJEMDA net product revenue trends, license revenue from ex-U.S. commercial rights, and reported cash, cash equivalents, and short-term investments. These updates are often accompanied by conference call details and investor presentations referenced in the company’s Form 8-K filings.
Another important category of DAWN news involves pipeline and portfolio developments. This includes progress in the Phase 1a/1b trial of DAY301, a PTK7-targeted antibody-drug conjugate, and the addition of Emi-Le (emiltatug ledadotin), a B7-H4–targeted ADC for adenoid cystic carcinoma, through the acquisition of Mersana Therapeutics. Corporate announcements around this acquisition, as well as participation in industry and investor conferences such as the J.P. Morgan Healthcare Conference and the Piper Sandler Healthcare Conference, are also reflected.
By reviewing this curated stream of official press releases and related disclosures, users can follow how Day One reports clinical milestones, commercial performance for OJEMDA, and strategic decisions that shape its oncology pipeline. Bookmarking the DAWN news page provides a centralized view of these developments as they are released.
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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.
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