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.
The Day One Biopharmaceuticals, Inc. (NASDAQ: DAWN) news page on Stock Titan aggregates company announcements, clinical updates, financial results, and corporate developments for this commercial-stage oncology biopharmaceutical company. Day One describes itself as dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, with a strong emphasis on pediatric cancer and rare cancers.
Investors and followers of DAWN can use this news feed to review updates on OJEMDA™ (tovorafenib), Day One’s Type II RAF kinase inhibitor indicated for certain BRAF-altered pediatric low-grade gliomas. Company press releases cover pivotal and follow-up data from the FIREFLY-1 Phase 2 trial, the ongoing FIREFLY-2/LOGGIC Phase 3 trial in front-line pLGG, and regulatory designations such as Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug status described in Day One’s communications.
The feed also captures financial results and guidance, including OJEMDA net product revenue trends, license revenue from ex-U.S. commercial rights, and reported cash, cash equivalents, and short-term investments. These updates are often accompanied by conference call details and investor presentations referenced in the company’s Form 8-K filings.
Another important category of DAWN news involves pipeline and portfolio developments. This includes progress in the Phase 1a/1b trial of DAY301, a PTK7-targeted antibody-drug conjugate, and the addition of Emi-Le (emiltatug ledadotin), a B7-H4–targeted ADC for adenoid cystic carcinoma, through the acquisition of Mersana Therapeutics. Corporate announcements around this acquisition, as well as participation in industry and investor conferences such as the J.P. Morgan Healthcare Conference and the Piper Sandler Healthcare Conference, are also reflected.
By reviewing this curated stream of official press releases and related disclosures, users can follow how Day One reports clinical milestones, commercial performance for OJEMDA, and strategic decisions that shape its oncology pipeline. Bookmarking the DAWN news page provides a centralized view of these developments as they are released.
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.
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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