Day One Biopharmaceuticals, Inc. operates as a holding company. The firm through its subsidiary develops and commercializes targeted therapies for patients of all ages with genetically defined cancers. Its products include DAY101 and pimsertib. The company was founded by Julie Grant and Samuel Blackman in November 2018 and is headquartered in Brisbane, CA.
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- Bicara Therapeutics appointed Jeremy Bender, Ph.D., and Christy Oliger to its Board of Directors, bringing extensive commercial and strategic expertise as the company transitions toward delivering ficerafusp alfa to patients. - Dr. Bender previously led Day One Biopharmaceuticals through its evolution into a commercial-stage oncology company, including the approval and launch of OJEMDA and a $2.5 billion acquisition by Servier in 2026. - Ms. Oliger, former SVP of the Oncology Business Unit at Genentech, managed a portfolio of 15 oncology products contributing over $13 billion in U.S. revenue and led launches across multiple cancer indications. - Founding board member Kiran Mazumdar-Shaw has retired from the board, having provided seed capital and strategic guidance that helped advance ficerafusp alfa into a registration-enabling clinical study.
- Servier will present updated long-term efficacy and safety data from the Phase 3 INDIGO trial of VORANIGO (vorasidenib) for IDH-mutant glioma, with over three years of follow-up supporting sustained treatment benefits. - Day One Biopharmaceuticals will share promising Phase 1 results for Emi-Le, a B7-H4-directed ADC showing favorable tolerability and antitumor activity in aggressive adenoid cystic carcinoma patients. - The presentations at ASCO 2026 demonstrate Servier's expanding rare oncology portfolio, targeting high unmet medical needs in brain tumors and rare cancers.
- The FDA has granted breakthrough therapy designation to emiltatug ledadotin (Emi-Le), a B7-H4-directed antibody-drug conjugate, for treating locally advanced, recurrent or metastatic adenoid cystic carcinoma with solid histology or high-grade transformation. - Phase 1 trial data demonstrated a manageable safety profile with 83.0% any-grade treatment-related adverse events and achieved a 55.6% overall response rate in evaluable patients with ACC type 1. - Adenoid cystic carcinoma affects more than 200,000 people globally with no currently approved systemic therapies for advanced or metastatic disease, representing a significant unmet medical need.
- Servier announced a definitive agreement to acquire Day One Biopharmaceuticals for $21.50 per share in cash, representing a total equity value of approximately $2.5 billion. - The acquisition positions Servier as a leader in pediatric low-grade glioma and expands its oncology pipeline with programs ranging from early stage to phase 3. - The transaction represents a premium of approximately 68% over Day One's closing price on March 5, 2026, and is expected to close in the second quarter of 2026. - The deal strengthens Servier's position in rare oncology and aligns with its 2030 ambition to develop innovative treatments for patients with high unmet medical needs.
- Day One Biopharmaceuticals reported preliminary 2025 OJEMDA net product revenue of $155.4 million, representing 172% year-over-year growth driven by increasing patient demand. - The company projects 2026 OJEMDA U.S. net product revenue between $225-250 million, representing 53% growth at the midpoint. - Day One completed the strategic acquisition of Mersana Therapeutics, adding Emi-Le (emiltatug ledadotin), a B7-H4-targeted ADC for adenoid cystic carcinoma. - The company plans to complete enrollment in the pivotal Phase 3 FIREFLY-2 trial for first-line pediatric low-grade glioma in the first half of 2026.
- Day One Biopharmaceuticals presented three-year follow-up data from the FIREFLY-1 trial showing 77% of pediatric low-grade glioma patients remained treatment-free for at least 12 months after completing OJEMDA therapy. - The median time to next treatment following OJEMDA initiation exceeded 3.5 years, with an overall response rate of 53% and median duration of response of 19.4 months in the pivotal trial. - Eight patients successfully received retreatment with OJEMDA after disease progression, achieving a median maximum tumor reduction of 38.3% during retreatment cycles. - The updated analysis with 40.6 months median study duration revealed minimal tumor rebound in the first six months off therapy, supporting OJEMDA's potential as second-line standard of care for BRAF-altered pediatric low-grade glioma.
- Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics for $129 million upfront, with potential additional payments of $156 million tied to development milestones. - The deal centers on Mersana's B7-H4-targeting ADC emiltatug ledadotin, which Day One plans to develop for adenoid cystic carcinoma type 1, a rare and aggressive cancer. - Mersana shareholders will receive $25 per share upfront, representing a 180% premium to Wednesday's closing price, though the company's stock had declined 75% year-to-date. - The acquisition provides Day One with Mersana's Dolasynthen ADC technology platform and $77 million in cash, expanding beyond its single approved drug Ojemda.
- Day One Biopharmaceuticals announced the acquisition of Mersana Therapeutics for up to $285 million to gain access to emiltatug ledadotin (Emi-Le), a novel antibody-drug conjugate targeting B7-H4. - Emi-Le has demonstrated early anti-tumor activity in an ongoing Phase 1 study for adenoid cystic carcinoma type-1 (ACC-1), an aggressive cancer with high unmet medical need and no approved therapies. - The acquisition positions Day One to leverage its existing capabilities to develop this potential first-in-class monotherapy through a clear registration pathway for a well-defined patient population. - The deal structure includes $25 per share upfront plus contingent value rights worth up to $30.25 per share based on clinical, regulatory, and commercial milestones.
- Day One Biopharmaceuticals announced a definitive merger agreement to acquire Mersana Therapeutics for $25 per share in cash, representing a 182% premium over the previous closing price. - The transaction includes potential milestone payments up to $30.25 per share through contingent value rights tied to Mersana's B7-H4-directed antibody-drug conjugate Emi-Le, bringing total potential value to $55.25 per share. - Mersana's stock surged over 200% in premarket trading following the announcement, with the deal valued at approximately $129 million at closing and up to $285 million including milestones. - The acquisition is expected to close by the end of January 2026, with Day One financing the transaction entirely through existing cash resources.
- XOMA Royalty Corporation reported robust financial performance in Q3 2025, receiving $43.9 million in royalties and milestones from partners in the first nine months of 2025, including $14.3 million in Q3 royalties. - The company completed strategic acquisitions of Turnstone Biologics and HilleVax while announcing planned acquisitions of LAVA Therapeutics and Mural Oncology to expand its royalty portfolio. - Key pipeline developments include Zevra Therapeutics submitting a Marketing Authorization Application to the EMA for arimoclomol in Niemann-Pick Type C disease and Rezolute Bio expecting Phase 3 ersodetug trial results in December 2025. - XOMA Royalty achieved net income of $14.1 million in Q3 2025 compared to a net loss of $17.2 million in the same period of 2024, demonstrating improved operational performance.