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 EventsInsider TradesNews and TrendsOwnership 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 Alkermes FDA EventsAvalyn Pharma FDA EventsCybin FDA EventsInsmed FDA EventsPrecigen FDA EventsQ32 Bio FDA EventsTiziana Life Sciences FDA EventsJohnson & Johnson FDA EventsMerck & Co., Inc. FDA EventsNovo Nordisk A/S FDA EventsCue Biopharma FDA EventsArcturus Therapeutics FDA EventsUltragenyx Pharmaceutical FDA EventsEli Lilly and Company FDA EventsTeva Pharmaceutical Industries 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 Praxis Precision Medicines FDA Events Vaxcyte FDA Events Cytokinetics FDA Events Apogee Therapeutics FDA Events TG Therapeutics FDA Events Ionis Pharmaceuticals FDA Events Alkermes FDA Events Rhythm Pharmaceuticals FDA Events Mirum Pharmaceuticals FDA Events Oruka Therapeutics 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. We continuously monitor for new FDA events and market data. From Our PartnersALERT: Drop these 5 stocks before the market opens tomorrow!The Wall Street Journal is already raising the alarm about a potential market crash, and Weiss Ratings researc...Weiss Ratings | SponsoredSmall Colorado Company (Backed by Sam Altman) Could Save U.S. Power GridA small Colorado company has secured rights to technology that could prevent the U.S. public power grid from c...Altimetry | SponsoredLouis Navellier: My #1 AI stock for 2026 (name & ticker inside)Louis Navellier's Stock Grader system helped him flag Nvidia before its 82,000% run and has identified the top...InvestorPlace | SponsoredReady to give options a try? Your first trade (Ticker included) -INSIDETired of trying tactic after tactic when it comes to options trades... only to be met with market noise and st...Base Camp Trading | SponsoredHere’s the stock symbol I’ve promisedWhitney Tilson of Stansberry Research has long recommended Berkshire Hathaway as a core retirement holding - b...Stansberry Research | SponsoredHere’s Why Trump Won’t End The Iran WarTrump has called an Iran deal close 38 times since the war began, yet the fighting keeps flaring back up. O...Banyan Hill Publishing | SponsoredThese gold assets are priced for $1,800 gold [it's over $4,000]Gold's major miners are generating record free cash flow, with margins as high as 75 percent even after gold's...Golden Portfolio | SponsoredYour book is insideThe "Sucker's Bet" Most New Options Traders Fall For Most people who try options lose money the same way. ...Profits Run | Sponsored Adding Choose a watchlist: Watchlist Adding You have already added ten stocks to your watchlist. Upgrade to MarketBeat All Access to add more stocks to your watchlist. Adding Day One Biopharmaceuticals, Inc. Please log in to your account or sign up in order to add this asset to your watchlist. Share Day One Biopharmaceuticals With A Colleague Link copied to clipboard. Unlock superior investment research and tools. Sign up for MarketBeat All Access to gain access to MarketBeat's full suite of research tools and reports. Get MarketBeat All Access MarketBeat All Access Features Best-in-Class Portfolio Monitoring Get personalized stock ideas. Compare portfolio to indices. Check stock news, ratings, SEC filings, and more. Stock Ideas and Recommendations See daily stock ideas from top analysts. Receive short-term trading ideas from MarketBeat. Identify trending stocks on social media. Advanced Stock Screeners and Research Tools Use our seven stock screeners to find suitable stocks. Stay informed with MarketBeat's real-time news. Export data to Excel for personal analysis. Sign in to your free account to enjoy these benefits In-depth profiles and analysis for 20,000 public companies. Real-time analyst ratings, insider transactions, earnings data, and more. Our daily ratings and market update email newsletter. Sign in to your free account to enjoy all that MarketBeat has to offer. Sign In Create Account Your Email Address: Email Address Required Your Password: Password Required Log In Email Me a Login Link or Sign in with Facebook Sign in with Google Forgot your password? Your Email Address: Please enter your email address. Please enter a valid email address Choose a Password: Please enter your password. Your password must be at least 8 characters long and contain at least 1 number, 1 letter, and 1 special character. Create My Account (Free) or Sign in with Facebook Sign in with Google By creating a free account, you agree to our terms of service. This site is protected by reCAPTCHA and the Google Privacy Policy and Terms of Service apply.
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
