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Day One Reports Preliminary 2024 OJEMDA™ Net Product Revenue and Highlights 2025 Corporate Priorities
Newsfilter· 2025-01-13 13:00
Core Insights - Day One Biopharmaceuticals reported preliminary unaudited net product revenue of approximately $57.2 million for 2024, with $29.0 million generated in the fourth quarter alone [2][3] - 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 [3] - OJEMDA received FDA accelerated approval in April 2024, becoming the first FDA-approved therapy for pediatric low-grade glioma [6] Financial Highlights - Preliminary 2024 OJEMDA net product revenue was approximately $57.2 million, with $29.0 million in the fourth quarter [2][7] - Cash, cash equivalents, and short-term investments totaled approximately $531.7 million as of December 31, 2024, compared to $366.3 million on December 31, 2023 [3] Business Updates - The company aims to drive OJEMDA revenue and invest in programs leveraging its expertise in development and commercialization [2] - Enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial for tovorafenib is expected to be completed in the first half of 2026 [6] - Day One has expanded its pipeline with the in-licensing of DAY301 and has cleared the first cohort in the Phase 1a portion of the DAY301 Phase 1a/b clinical trial [6] Upcoming Priorities - The company plans to continue growing OJEMDA revenue and advancing its existing pipeline, including the FIREFLY-2 Phase 3 clinical trial and DAY301 [6] - Day One will pursue business development opportunities to expand its pipeline while maintaining a self-sustaining financial position [6]
Day One Reports Preliminary 2024 OJEMDA™ Net Product Revenue and Highlights 2025 Corporate Priorities
Globenewswire· 2025-01-13 13:00
Core Insights - Day One Biopharmaceuticals reported preliminary unaudited net product revenue of approximately $57.2 million for 2024, with $29.0 million generated in the fourth quarter [2][6] - The company ended 2024 with approximately $531.7 million in cash, cash equivalents, and short-term investments, an increase from $366.3 million at the end of 2023 [2][6] - OJEMDA received FDA accelerated approval in April 2024, becoming the first FDA-approved therapy for pediatric low-grade glioma [5] - The company is focused on driving OJEMDA revenue, advancing its pipeline, and maintaining a strong financial position in 2025 [1][13] Financial Performance - Preliminary net product revenues for 2024 were approximately $57.2 million, with the fourth quarter contributing around $29.0 million [2] - Cash, cash equivalents, and short-term investments totaled approximately $531.7 million as of December 31, 2024, compared to $366.3 million on December 31, 2023 [2] Regulatory and Clinical Developments - OJEMDA received FDA accelerated approval for treating patients aged 6 months and older with relapsed or refractory pediatric low-grade glioma [5] - The Centers for Medicare & Medicaid Services approved OJEMDA exclusively for pediatric indications, reducing its Medicaid and 340B minimum rebate percentage from 23.1% to 17.1% [5] - Enrollment in the pivotal Phase 3 FIREFLY-2 clinical trial for tovorafenib is progressing, with over 100 sites activated globally [5] Strategic Initiatives - The company aims to continue growing OJEMDA revenue and advance its existing pipeline, including the FIREFLY-2 Phase 3 trial and DAY301 Phase 1a/b trial [13] - Day One has entered into an exclusive licensing agreement with Ipsen to commercialize tovorafenib outside the U.S. [5] - The company is pursuing business development opportunities to expand its pipeline while maintaining a self-sustaining financial position [13]
Top 5 Commercial Biotech Buyout Candidates: Day One Biopharmaceuticals (No. 5)
Seeking Alpha· 2025-01-07 16:31
Since they bottomed in October 2022, the main stock indices have skyrocketed, The S&P 500 recording back-to-back gains of over 20% in 2023-2024, and the tech/growth-oriented Nasdaq-100 has performed even better.They lead the investing group Wheel of Fortune where they share actionable trading ideas across all asset-classes, sectors and industries. The goal of the service is to provide a one-stop-shop for investment and portfolio ideas, while educating the vibrant community of subscribers. Features of the se ...
Day One Biopharmaceuticals: Sales Figures In The Crosshairs
Seeking Alpha· 2024-12-25 12:31
Day One Biopharmaceuticals (NASDAQ: DAWN ) is a commercial-stage biotech focused on the development and marketing of mostly one drug: an RAF kinase inhibitor indicated for children with certain forms of brain cancer. The company has vacillated between $1 and $2 billion inI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you d ...
Day One to Present at the 43rd Annual J.P. Morgan Healthcare Conference
Newsfilter· 2024-12-17 13:30
Company Overview - Day One Biopharmaceuticals is a biopharmaceutical company focused on developing and commercializing targeted therapies for life-threatening diseases across all age groups [1] - The company was founded to address the critical unmet need in pediatric cancer therapeutic development [3] - Day One aims to re-envision cancer drug development and redefine treatment possibilities for all cancer patients, inspired by "The Day One Talk" between physicians and patients [3] Pipeline and Partnerships - The company's pipeline includes tovorafenib (OJEMDA™), DAY301, and a VRK1 inhibitor program [4] - Day One collaborates with leading clinical oncologists, families, and scientists to identify, acquire, and develop targeted cancer treatments [4] Upcoming Event - Dr Jeremy Bender, CEO of Day One Biopharmaceuticals, will present at the 43rd Annual J P Morgan Healthcare Conference on January 13, 2025, at 3:45 PM Pacific Time / 6:45 PM Eastern Time [1] - A live audio webcast of the presentation will be available on the company's website, with an archived replay accessible for 30 days post-presentation [2] Corporate Information - Day One Biopharmaceuticals is headquartered in Brisbane, California [4] - The company utilizes its Investor Relations website, X handle, and LinkedIn page for disseminating business and financial information, including news, announcements, and regulatory disclosures [5]
Day One Announces Retirement of Dr. Samuel Blackman, Co-Founder and Head of Research & Development
GlobeNewswire News Room· 2024-11-20 21:30
Dr. Blackman’s departure planned for end of 2024 Company’s search for a new Head of R&D is ongoing BRISBANE, Calif., Nov. 20, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that Samuel Blackman, M.D., Ph.D, co-founder and Head of Research & Development (R&D) of the Company, will be retiring ef ...
Day One to Participate in the Piper Sandler 36th Annual Healthcare Conference
GlobeNewswire News Room· 2024-11-18 13:30
BRISBANE, Calif., Nov. 18, 2024 (GLOBE NEWSWIRE) -- Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) (“Day One” or the “Company”), a biopharmaceutical company dedicated to developing and commercializing targeted therapies for people of all ages with life-threatening diseases, today announced that management will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3 at 3:00 p.m. EST. A live webcast of the discussion will be available by visiting the Event ...
Wall Street Analysts See a 136.83% Upside in Day One Biopharmaceuticals (DAWN): Can the Stock Really Move This High?
ZACKS· 2024-11-06 15:55
Shares of Day One Biopharmaceuticals, Inc. (DAWN) have gained 10.7% over the past four weeks to close the last trading session at $15.15, but there could still be a solid upside left in the stock if short-term price targets of Wall Street analysts are any indication. Going by the price targets, the mean estimate of $35.88 indicates a potential upside of 136.8%.The average comprises eight short-term price targets ranging from a low of $28 to a high of $44, with a standard deviation of $5.19. While the lowest ...
Day One Biopharmaceuticals pany(DAWN) - 2024 Q3 - Earnings Call Transcript
2024-10-31 02:57
Day One Biopharmaceuticals, Inc. (NASDAQ:DAWN) Q3 2024 Earnings Conference Call October 30, 2024 4:30 PM ET Company Participants Joey Perrone - SVP, Finance and IR Jeremy Bender - CEO Lauren Merendino - CCO Samuel Blackman - Co-Founder and Head, R&D Charles York - COO and CFO Conference Call Participants Anupam Rama - JPMorgan Joe Catanzaro - Piper Sandler Andrea Newkirk - Goldman Sachs Soumit Roy - Jones Research Alec Stranahan - Bank of America Ami Fadia - Needham & Company Andres Maldonado - H.C. Wainwri ...
Day One Biopharmaceuticals, Inc. (DAWN) Surpasses Q3 Earnings and Revenue Estimates
ZACKS· 2024-10-30 22:20
Day One Biopharmaceuticals, Inc. (DAWN) came out with quarterly earnings of $0.38 per share, beating the Zacks Consensus Estimate of a loss of $0.20 per share. This compares to loss of $0.54 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 290%. A quarter ago, it was expected that this company would post a loss of $0.67 per share when it actually produced a loss of $0.05, delivering a surprise of 92.54%.Over the last four quart ...