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Day One Biopharmaceuticals, Inc. - DAWN STOCK NEWS

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.

Day One Biopharmaceuticals, Inc. (Nasdaq: DAWN) is a clinical-stage company pioneering targeted therapies for pediatric and adult cancers with genetic drivers. This page aggregates official press releases, regulatory filings, and verified news about DAWN's innovative oncology pipeline, including FDA-approved OJEMDA for pediatric low-grade glioma and investigational candidates like PTK7-targeting DAY301.

Investors and researchers will find updates on clinical trial progress, partnership announcements, and scientific developments. Content categories include earnings reports, research collaborations, regulatory milestones, and therapeutic pipeline advancements. All materials are sourced directly from company communications or reputable financial/medical publications.

Bookmark this page for structured access to DAWN's latest developments in precision oncology. Check regularly for updates on their mission to transform cancer treatment through genetically targeted therapies.

News

Day One Reports Third Quarter 2023 Financial Results and Corporate Progress

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Day One Biopharmaceuticals announced that the FDA has accepted the New Drug Application (NDA) for tovorafenib in relapsed or progressive pediatric low-grade glioma (pLGG) for Priority Review. The Prescription Drug User Fee Act (PDUFA) target action date is set for April 30, 2024. Day One also highlighted recent corporate achievements and financial results for the third quarter of 2023.
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Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

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Day One Biopharmaceuticals has announced that the FDA has accepted its New Drug Application for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG). The FDA has granted priority review and set a target action date of April 30, 2024. pLGG is the most common brain tumor in children with no approved therapy. The NDA is based on results from a Phase 2 trial, and the company may receive a priority review voucher.
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Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)

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Day One Biopharmaceuticals submits NDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma (pLGG)
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Day One Announces VRK1 License Agreement and Research Collaboration with Sprint Bioscience

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Day One Biopharmaceuticals has entered into an exclusive license agreement and research collaboration with Sprint Bioscience for its VRK1 program. VRK1 is a target involved in cell division and DNA damage repair, and its over-expression is linked to poor prognosis in various cancers. Day One will pay an upfront payment of $3 million to Sprint Bioscience and may make additional milestone payments of up to $313 million.
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Day One Reports Second Quarter 2023 Financial Results and Corporate Progress

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Day One Biopharmaceuticals announces positive results from FIREFLY-1 trial, with an overall response rate (ORR) of 67% and clinical benefit rate (CBR) of 93% in patients with relapsed or progressive pediatric low-grade glioma (pLGG). The company has initiated the rolling submission of the tovorafenib New Drug Application (NDA) and expects to complete it by October 2023. Day One also completed a $172.5 million public offering, strengthening their balance sheet.
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Day One Announces Pricing of Public Offering of Common Stock

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Day One Announces Proposed Public Offering of Common Stock

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Day One Announces New FIREFLY-1 Data for Tovorafenib (DAY101) and Initiation of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma

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Day One to Participate in the Goldman Sachs 44th Annual Healthcare Conference

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Day One Announces Tovorafenib (DAY101) Data and Additional Abstracts to be Presented at the 2023 American Society of Clinical Oncology (ASCO) Annual Meeting

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Day One Biopharmaceuticals, Inc.

Nasdaq:DAWN

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693.26M
83.45M
16.97%
94.6%
17.93%
Biotechnology
Pharmaceutical Preparations
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United States
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