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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.

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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.

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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.

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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.

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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.

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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.

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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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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.

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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.

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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.

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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.

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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 $7.22 as of April 4, 2025.

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

The market cap of Day One Biopharmaceuticals (DAWN) is approximately 743.9M.

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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743.94M
83.45M
16.97%
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17.93%
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