This 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 and MTX-13. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
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.
- Drug:
- Tovorafenib
- Announced Date:
- November 10, 2025
- Indication:
- For Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
Announcement
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.
AI Summary
Day 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
MTX-13 FDA Regulatory Events
MTX-13 is a drug developed by Day One Biopharmaceuticals for the following indication: ADC targeting protein-tyrosine kinase 7 (PTK7).
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.
- Drug:
- MTX-13
- Announced Date:
- June 18, 2024
- Indication:
- ADC targeting protein-tyrosine kinase 7 (PTK7)
Announcement
Day One Biopharmaceuticals announced it has entered into an exclusive licensing agreement (the Agreement) with MabCare Therapeutics (MabCare) for MTX-13, a novel ADC targeting protein-tyrosine kinase 7 (PTK7).
AI Summary
Day One Biopharmaceuticals announced an exclusive licensing agreement with MabCare Therapeutics to acquire rights for MTX-13, a novel antibody-drug conjugate (ADC) that targets protein-tyrosine kinase 7 (PTK7). PTK7, highly expressed in many adult and pediatric solid tumors, presents an attractive target since it is minimally found in healthy tissues. Under the Agreement, Day One obtains exclusive rights to develop, manufacture, and commercialize MTX-13 worldwide, excluding Greater China. The ADC, which has been rebranded as DAY301 following IND clearance by the FDA in April 2024, has demonstrated promising antitumor activity in pre-clinical studies. This development marks a significant addition to Day One’s pipeline, as the company looks to expand its portfolio of targeted cancer treatments for both adults and children.
Read Announcement
Free DAWN Stock Alerts