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Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a clinical-stage biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with genetically defined cancers. Founded with a mission to address the significant unmet needs in pediatric cancer treatment, Day One's approach starts with the biology of childhood cancer to bring forward innovative therapies that benefit both children and adults.
The company’s lead product candidate, tovorafenib (OJEMDA™), is an investigational, oral, brain-penetrant, highly-selective type II RAF kinase inhibitor. Tovorafenib targets a key enzyme in the MAPK signaling pathway and is currently under evaluation in two pivotal clinical trials for pediatric low-grade glioma (pLGG). The FDA has granted it Breakthrough Therapy and Rare Pediatric Disease designations for the treatment of patients with pLGG harboring an activating RAF alteration. On April 23, 2024, the FDA approved OJEMDA for the treatment of patients 6 months of age and older with relapsed or refractory pLGG harboring a BRAF fusion or rearrangement, or BRAF V600 mutation, marking a significant milestone for Day One.
Additionally, pLGG is the most common brain tumor diagnosed in children, accounting for 30% - 50% of all central nervous system tumors in this population. The absence of approved therapies for most pLGG patients underscores the chronic and relentless nature of the disease, which can significantly impact the long-term quality of life. Day One's FIREFLY-1 and FIREFLY-2/LOGGIC trials are evaluating tovorafenib in both relapsed and front-line settings, aiming to revolutionize the treatment landscape for these young patients.
Day One's robust pipeline also includes pimasertib, an investigational, oral, highly-selective small molecule inhibitor of mitogen‐activated protein kinases 1 and 2 (MEK-1/-2). The company is actively exploring additional clinical opportunities that leverage its innovative approach to cancer treatment.
With a dedicated team and strong partnerships with leading clinical oncologists, families, and scientists, Day One aims to continuously advance its mission. The company is headquartered in Brisbane, California, and remains committed to its vision of making a significant difference from Day One for all patients living with cancer.
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.
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.
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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