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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.

Company Overview

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a commercial-stage biopharmaceutical company committed to developing and commercializing targeted therapies for genetically defined cancers. With a distinct focus on pediatric oncology, the company has built its foundation around addressing the critical unmet needs in childhood cancer, particularly pediatric low-grade glioma (pLGG), while extending its expertise to adult oncology. This dual emphasis on both pediatric and adult patient populations underscores its innovative approach in cancer drug development and targeted therapeutics.

Clinical Programs and Pipeline

At the heart of Day One's operations is a pipeline of promising therapies, each designed to offer precision treatment to patients with life-threatening cancers. The company has achieved significant milestones through its clinical development programs:

  • OJEMDA (tovorafenib): An oral, brain-penetrant, and highly selective type II RAF inhibitor engineered to treat relapsed or refractory pLGG in patients as young as 6 months old. This product leverages advanced scientific insights and a refined understanding of pediatric oncology to cater to a historically underserved population.
  • DAY301: A novel antibody-drug conjugate (ADC) targeting protein-tyrosine kinase 7 (PTK7) overexpressed in various solid tumors. With potential applications in both pediatric and adult oncology, DAY301 represents Day One’s commitment to broadening treatment options through innovative molecular targeting strategies.
  • Other pipeline assets include investigational programs focusing on kinase inhibitors and novel targeted therapies that address the unique genetic profiles of various cancers.

Scientific and Clinical Approach

Day One Biopharmaceuticals employs a scientific approach that integrates deep molecular insights with clinical research. Key elements of their approach include:

  • Precision Targeting: Utilizing genomic and molecular profiling to identify the subsets of cancer that may best respond to targeted therapies, ensuring that treatments are tailored to the specific genetic abnormalities driving the disease.
  • Collaborative Networks: Partnering with leading clinical oncologists, pediatric specialists, and research institutes to optimize clinical trial designs and accelerate the development of innovative therapies.
  • Regulatory Rigor: Designing clinical studies to meet the high standards of regulatory agencies, with a focus on demonstrating both safety and efficacy to secure accelerated or breakthrough designations when appropriate.

Market Position and Competitive Landscape

Day One Biopharmaceuticals positions itself uniquely in the competitive biopharmaceutical landscape by addressing the significant gap in pediatric cancer treatments. While many biotechnology companies focus primarily on adult cancers, Day One’s commitment to pediatric oncology provides a crucial differentiator. The company’s strategic focus on genetically defined cancers and its use of precision medicine methods have allowed it to carve out a niche in the targeted therapeutics space. Its collaborations with pediatric oncology experts and robust clinical programs underscore its commitment to advancing therapies that have meaningful clinical benefits for vulnerable patient groups.

Operational Excellence and Strategic Collaborations

The company’s operational model is built around the integration of scientific research and clinical expertise. Through strategic licensing agreements and collaborative ventures with healthcare institutions, Day One has expanded its research capabilities and access to cutting-edge technologies. This integrated approach allows the translation of novel scientific discoveries into clinical applications effectively, ensuring that treatment innovations reach patients with the urgency they require. The company’s commitment to operational excellence is further reflected in its ability to secure regulatory approvals and the ongoing evolution of its therapeutic portfolio.

Regulatory Achievements and Impact on Patient Care

A cornerstone of Day One’s credibility and market authority is its success in navigating complex regulatory pathways. The approval of OJEMDA by the U.S. Food and Drug Administration (FDA) represents a significant achievement for the company, as it validates their scientific approach and commitment to addressing critical medical needs. These regulatory milestones not only emphasize the robustness of the company’s clinical data but also set a precedent for future advancements in targeted cancer therapeutics.

Commitment to Addressing Unmet Needs

Day One Biopharmaceuticals remains steadfast in its commitment to improving patient outcomes by focusing on illnesses that have historically seen slow progress in therapeutic development. By concentrating efforts on pediatric cancers such as pLGG, the company ensures that vulnerable patients receive innovative treatments derived from rigorous research and development. This mission is not only a reflection of their business model but also resonates with the broader oncology community that values precision, efficacy, and compassionate innovation.

Summary

Overall, Day One Biopharmaceuticals represents a contemporary model in biopharmaceutical innovation. Its comprehensive pipeline of targeted therapies, strategic collaborations, and deep integration of clinical expertise position it as a critical player in the evolving landscape of cancer treatment. With a dedication to serving both pediatric and adult populations, the company continually refines its approach to meet complex clinical challenges, ultimately paving the way for transformative changes in oncology care.

Rhea-AI Summary

Day One Biopharmaceuticals (Nasdaq: DAWN) has secured an exclusive license from MabCare Therapeutics for MTX-13 (DAY301), a novel antibody drug conjugate (ADC) targeting PTK7, which is highly expressed in a range of adult and pediatric solid tumors. The investigational new drug (IND) application for DAY301 was cleared by the FDA in April 2024. The agreement includes $55 million upfront payment and up to $1.152 billion in potential milestone payments. Day One aims to dose the first patient in a Phase I study by late 2024 or early 2025.

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Day One Biopharmaceuticals (Nasdaq: DAWN) announced the sale of its Priority Review Voucher (PRV) for $108 million to an undisclosed buyer. The PRV was awarded following the FDA's accelerated approval of OJEMDA™ (tovorafenib). This sale provides non-dilutive capital, strengthening Day One's balance sheet to support the launch of OJEMDA and further clinical development for cancer treatments. Additionally, $8.1 million from the sale will be paid to Viracta Therapeutics to fulfill obligations under a license agreement.

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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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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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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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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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FAQ

What is the current stock price of Day One Biopharmaceuticals (DAWN)?

The current stock price of Day One Biopharmaceuticals (DAWN) is $7.61 as of April 1, 2025.

What is the market cap of Day One Biopharmaceuticals (DAWN)?

The market cap of Day One Biopharmaceuticals (DAWN) is approximately 772.8M.

What is the core focus of Day One Biopharmaceuticals?

The company is dedicated to developing and commercializing targeted therapies for genetically defined cancers, with a particular emphasis on pediatric oncology and addressing unmet needs in childhood cancer.

Which patient populations does Day One primarily serve?

Day One focuses on both pediatric and adult patients afflicted with genetically defined cancers, ensuring that vulnerable groups, especially children with low-grade glioma, receive tailored therapeutic solutions.

What are the key therapeutic areas the company addresses?

The company develops targeted cancer therapies, with key areas including pediatric low-grade glioma (pLGG) and various solid tumors, using precision medicine approaches to treat genetically defined malignancies.

Can you describe the significance of OJEMDA?

OJEMDA (tovorafenib) is an oral, brain-penetrant type II RAF inhibitor approved for treating relapsed or refractory pLGG, representing a significant achievement in targeted therapy for pediatric cancer.

What distinguishes Day One's scientific approach?

Their approach integrates detailed genomic profiling with clinical expertise, enabling precise targeting of cancer drivers, while collaborating with leading oncologists and research institutions to optimize therapy development.

How does Day One enhance its development pipeline?

The company continuously expands its pipeline through strategic licensing and collaborative research, ensuring a robust portfolio that includes both approved therapies and innovative investigational programs.

Is there a focus on rare diseases within the company’s strategy?

Yes, Day One actively targets genetically defined cancers that are often underrepresented in traditional drug development, including rare pediatric conditions, to fill a critical gap in unmet medical needs.

How is the company positioned within the competitive biopharmaceutical landscape?

Day One differentiates itself by focusing on precision oncology for both pediatric and adult patients, leveraging scientific rigor, strategic collaborations, and regulatory achievements to address significant treatment gaps.

What role do strategic partnerships play at Day One?

Strategic partnerships with clinical experts, academic institutions, and research organizations are essential to its model, facilitating successful clinical trial designs and accelerating the development of innovative therapies.

How does Day One ensure the quality and safety of its therapies?

The company designs rigorous clinical studies and adheres to strict regulatory standards, ensuring that its therapies undergo comprehensive evaluation for both safety and efficacy before commercialization.
Day One Biopharmaceuticals, Inc.

Nasdaq:DAWN

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