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 (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.