This company has been marked as potentially delisted and may not be actively trading. Day One Biopharmaceuticals (DAWN) FDA Approvals Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsEarningsFDA EventsHeadlinesInsider TradesOwnershipTrendsBuy This Stock Day One Biopharmaceuticals' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Day One Biopharmaceuticals (DAWN). Over the past two years, Day One Biopharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Tovorafenib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Tovorafenib FDA Regulatory Events Tovorafenib is a drug developed by Day One Biopharmaceuticals for the following indication: For Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. New Data - November 10,2025New Data Drug: TovorafenibAnnounced Date: November 10, 2025Indication: For Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)AnnouncementDay One Biopharmaceuticals, Inc announced it will present new OJEMDA durability and clinical stability data from the registrational FIREFLY-1 study at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology (SNO), being held November 19-23, 2025.AI SummaryDay One Biopharmaceuticals will present new durability and clinical stability data for OJEMDA (tovorafenib) from the pivotal FIREFLY-1 study at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology (SNO), held November 19–23, 2025. The abstract includes an earlier data cut, and Day One says updated results will be shown during the meeting. In an oral presentation on November 23 at 11:49 a.m. in the Liliʻu Theater, Dr. Cassie Klein will report more than 36 months of follow-up from the Phase 2 FIREFLY-1 trial. The study evaluated once-weekly tovorafenib as monotherapy in patients aged 6 months to 25 years with relapsed or progressive pediatric low-grade glioma (pLGG) carrying an activating BRAF alteration. Dr. Klein will also disclose, for the first time, treatment-free interval (TFI) data for patients who stopped after completing the full 26 cycles (~24 months). Three-year follow-up shows durable responses and evidence of clinical stability off treatment, with the potential for retreatment after progression. These findings will be detailed in the SNO presentation and are intended to strengthen the clinical profile of OJEMDA.Read Announcement Day One Biopharmaceuticals FDA Events - Frequently Asked Questions Has Day One Biopharmaceuticals received FDA approval? As of now, Day One Biopharmaceuticals (DAWN) has not received any FDA approvals for its therapy in the last two years. What drugs has Day One Biopharmaceuticals submitted to the FDA? In the past two years, Day One Biopharmaceuticals (DAWN) has reported FDA regulatory activity for Tovorafenib. What is the most recent FDA event for Day One Biopharmaceuticals? The most recent FDA-related event for Day One Biopharmaceuticals occurred on November 10, 2025, involving Tovorafenib. The update was categorized as "New Data," with the company reporting: "Day One Biopharmaceuticals, Inc announced it will present new OJEMDA durability and clinical stability data from the registrational FIREFLY-1 study at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology (SNO), being held November 19-23, 2025." What conditions do Day One Biopharmaceuticals' current drugs treat? Currently, Day One Biopharmaceuticals has one therapy (Tovorafenib) targeting the following condition: For Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG). More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events AC Immune FDA EventsBelite Bio FDA EventsCingulate FDA EventsEikon Therapeutics FDA EventsInnoviva FDA EventsPhio Pharmaceuticals FDA EventsRenovoRx FDA EventsRhythm Pharmaceuticals FDA EventsAbCellera Biologics FDA EventsAlumis FDA EventsAquestive Therapeutics FDA EventsArtelo Biosciences FDA EventsGrifols FDA EventsKodiak Sciences FDA EventsKura Oncology FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Protagonist Therapeutics FDA Events Praxis Precision Medicines FDA Events Kymera Therapeutics FDA Events Apogee Therapeutics FDA Events Immunovant FDA Events Vaxcyte FDA Events Cogent Biosciences FDA Events TG Therapeutics FDA Events Rhythm Pharmaceuticals FDA Events Mirum Pharmaceuticals FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare Stocks FDA progress for NASDAQ:DAWN last updated on 11/10/2025 by MarketBeat.com Staff. 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New Data - November 10,2025New Data Drug: TovorafenibAnnounced Date: November 10, 2025Indication: For Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)AnnouncementDay One Biopharmaceuticals, Inc announced it will present new OJEMDA durability and clinical stability data from the registrational FIREFLY-1 study at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology (SNO), being held November 19-23, 2025.AI SummaryDay One Biopharmaceuticals will present new durability and clinical stability data for OJEMDA (tovorafenib) from the pivotal FIREFLY-1 study at the 30th Annual Meeting & Education Day of the Society for Neuro-Oncology (SNO), held November 19–23, 2025. The abstract includes an earlier data cut, and Day One says updated results will be shown during the meeting. In an oral presentation on November 23 at 11:49 a.m. in the Liliʻu Theater, Dr. Cassie Klein will report more than 36 months of follow-up from the Phase 2 FIREFLY-1 trial. The study evaluated once-weekly tovorafenib as monotherapy in patients aged 6 months to 25 years with relapsed or progressive pediatric low-grade glioma (pLGG) carrying an activating BRAF alteration. Dr. Klein will also disclose, for the first time, treatment-free interval (TFI) data for patients who stopped after completing the full 26 cycles (~24 months). Three-year follow-up shows durable responses and evidence of clinical stability off treatment, with the potential for retreatment after progression. These findings will be detailed in the SNO presentation and are intended to strengthen the clinical profile of OJEMDA.Read Announcement
