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 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.
Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) successfully closed an upsized public offering of 11,500,000 shares at $15.00 per share on June 17, 2022. This offering, which included an option for underwriters to purchase an additional 1,500,000 shares, generated gross proceeds of $172.5 million. The funds raised will aid Day One in advancing its targeted therapies for pediatric cancer. J.P. Morgan, Cowen, and Piper Sandler managed the offering. The securities are registered under the SEC's regulations, with full details available on their website.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced the pricing of an upsized underwritten public offering of 10,000,000 shares at $15.00 each, generating expected gross proceeds of $150 million. The offering will close around June 17, 2022, subject to standard conditions. Underwriters have a 30-day option for an additional 1,500,000 shares. J.P. Morgan, Cowen, and Piper Sandler are co-managers of the offering. The offering is registered under SEC guidelines and aims to bolster the company’s efforts in developing targeted therapies for pediatric 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.
