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.
Day One Biopharmaceuticals (DAWN) reported its Q4 and full year 2024 financial results, highlighting strong performance of its flagship drug OJEMDA. The company achieved $29.0 million in Q4 OJEMDA net product revenues, a 44% increase from Q3, and $57.2 million for the full year 2024.
Since OJEMDA's launch in April 2024, over 1,600 prescriptions have been written. The drug received Exclusively Pediatric designation from CMS, reducing its Medicaid and 340B minimum rebate percentage to 17.1%. The company reported a net loss of $65.7 million for Q4 and $95.5 million for full year 2024.
R&D expenses increased to $227.7 million for 2024, primarily due to DAY301-related payments. The company maintains a strong financial position with $531.7 million in cash and equivalents as of December 31, 2024.
Day One Biopharmaceuticals (DAWN) has announced it will host a conference call and webcast on Tuesday, February 25, 2025, at 4:30 p.m. ET to discuss its fourth quarter and full-year 2024 financial results and corporate progress. The live audio webcast will be available on the company's Investors & Media page, with a replay accessible for 30 days following the event in the Events & Presentations section.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported preliminary unaudited 2024 net product revenue of approximately $57.2 million for OJEMDA™ (tovorafenib). The fourth-quarter revenue for OJEMDA reached around $29.0 million. The company ended 2024 with approximately $531.7 million in cash, cash equivalents, and short-term investments, a significant increase from $366.3 million at the end of 2023.
OJEMDA received FDA accelerated approval in April 2024, making it the first FDA-approved therapy for relapsed or refractory pediatric low-grade glioma (pLGG) with a BRAF fusion, rearrangement, or BRAF V600 mutation. Additionally, CMS approved OJEMDA exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1%.
Day One advanced its pipeline by progressing the Phase 3 FIREFLY-2 clinical trial and initiating the Phase 1a/b trial for DAY301, a PTK7-targeted ADC. The company entered into an exclusive licensing agreement with Ipsen for tovorafenib commercialization outside the U.S.
For 2025, Day One aims to grow OJEMDA revenue, advance its clinical trials, pursue business development opportunities, and maintain a self-sustaining financial position. Full financial results for Q4 and the full year 2024 will be issued in February 2025.
Day One Biopharmaceuticals (Nasdaq: DAWN), a company focused on developing targeted therapies for life-threatening diseases, has announced its participation in the 43rd Annual J.P. Morgan Healthcare Conference. Dr. Jeremy Bender, the company's CEO, will deliver a presentation on Monday, January 13 at 3:45 p.m. Pacific Time / 6:45 p.m. Eastern Time.
Interested parties can access a live audio webcast of the presentation through the Events & Presentations section on Day One's website. The webcast recording will remain available for replay for 30 days after the live presentation.
Day One Biopharmaceuticals (Nasdaq: DAWN) announced that co-founder and Head of Research & Development, Dr. Samuel Blackman, will retire at the end of 2024. He will continue as a strategic advisor while the company searches for a new Head of R&D. Under Dr. Blackman's leadership since 2018, Day One acquired and developed tovorafenib, which received FDA approval in April 2024. The company, focused on developing targeted therapies for life-threatening diseases, will have Chief Medical Officer Dr. Elly Barry lead the clinical and medical teams during the transition period.
Day One Biopharmaceuticals (Nasdaq: DAWN) has announced its participation in the Piper Sandler 36th Annual Healthcare Conference. The company's management will engage in a fireside chat on Tuesday, December 3 at 3:00 p.m. EST.
Interested parties can access a live webcast of the discussion through the Events & Presentations section of Day One's Investors & Media page. The webcast recording will remain available for 30 days after the live event.
Day One Biopharmaceuticals reported strong Q3 2024 financial results, with OJEMDA net product revenue reaching $20.1 million, a 145% increase from Q2 2024. Quarterly prescriptions grew 159% to 619. The company reported net income of $37.0 million and ended the quarter with $558.4 million in cash and equivalents. Key highlights include a licensing agreement with Ipsen for ex-U.S. commercialization of tovorafenib, bringing $111 million upfront with potential additional milestones of $350 million. Updated data from the FIREFLY-1 trial showed an 18-month median duration of response for tovorafenib in pLGG patients.
Day One Biopharmaceuticals (Nasdaq: DAWN), a company focused on developing targeted therapies for life-threatening diseases, has announced its plans to report third quarter 2024 financial results on Wednesday, October 30, 2024. The company will host a live conference call and webcast at 4:30 p.m. ET to discuss financial results and corporate progress.
Interested parties can access the live audio webcast on the Day One Investors & Media page. For those unable to attend the live event, an archived version of the webcast will be available for replay on the Events & Presentations section of the same page for 30 days following the event.
Day One Biopharmaceuticals (Nasdaq: DAWN) reported strong Q2 2024 results, highlighted by $8.2 million in OJEMDATM (tovorafenib) net product revenues in its initial 2 months of launch. The company expanded its pipeline with DAY301, a potential first-in-class Antibody Drug Conjugate targeting PTK7. Day One entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. for approximately $111 million upfront in cash and equity investment. The company also secured an oversubscribed private placement for total gross proceeds of about $175 million.
Financial highlights include a cash position of $361.9 million as of June 30, 2024. R&D expenses increased to $92.1 million, primarily due to a $55 million upfront payment for the MabCare Therapeutics license agreement. Net loss for Q2 2024 was $4.4 million, compared to $45.9 million in Q2 2023.
Day One Biopharmaceuticals (Nasdaq: DAWN) has secured an oversubscribed $175.0 million private placement of its securities. The placement includes 10,551,718 shares of common stock at $14.50 per share and 1,517,241 pre-funded warrants at $14.4999 each. Notable investors include Fairmount, Braidwell LP, Deerfield Management, and Wellington Management. The company plans to use the proceeds to fund commercial capabilities, research and development, potential acquisitions, and working capital. The private placement is expected to close on August 1, 2024, subject to customary conditions. J.P. Morgan, TD Cowen, Goldman Sachs & Co. , and Piper Sandler are acting as joint placement agents.
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