Day One Biopharmaceuticals, Inc.
Day One Biopharmaceuticals is dedicated to developing targeted medicines for children and adults with serious diseases, aiming to bring life-changing therapies to patients faster. Founded in 2018, the company has achieved FDA approval for its first medicine, OJEMDA™, and is actively advancing its pipeline with innovative programs like Tovorafenib and DAY301. The company emphasizes a culture of collaboration, urgency, and integrity, working closely with patients, families, and partners to redefine hope from Day One.
Industries
Nr. of Employees
medium (51-250)
Day One Biopharmaceuticals, Inc.
1800 Sierra Point Parkway, Suite 200, Brisbane, CA 94005
Patents
Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
US-10426782-B2
View DetailsSubstituted 1,3-thiazoles as synthetic intermediates for preparation of Raf kinase inhibitors
US-9556177-B2
View Details
Pharmaceutical formulations of a pan-RAF kinase inhibitor and processes for their preparation
US-10426782-B2
View DetailsSubstituted 1,3-thiazoles as synthetic intermediates for preparation of Raf kinase inhibitors
US-9556177-B2
View DetailsProducts
OJEMDA (tovorafenib)
An FDA‑approved, oral, brain‑penetrant type II RAF kinase inhibitor developed for treatment of certain pediatric low‑grade gliomas harboring activating RAF alterations.
DAY301 (PTK7-targeted ADC)
A clinical-stage PTK7-directed antibody–drug conjugate developed for adult and pediatric solid tumors; currently in Phase 1 dose-escalation and expansion studies.
OJEMDA (tovorafenib)
An FDA‑approved, oral, brain‑penetrant type II RAF kinase inhibitor developed for treatment of certain pediatric low‑grade gliomas harboring activating RAF alterations.
DAY301 (PTK7-targeted ADC)
A clinical-stage PTK7-directed antibody–drug conjugate developed for adult and pediatric solid tumors; currently in Phase 1 dose-escalation and expansion studies.
Services
Collaborative partnerships for identification, acquisition, and co‑development or licensing of therapeutic programs, including external licensing and global commercialization agreements.
Consideration of support for investigator-initiated clinical studies via provision of investigational drug, funding, or other collaboration under formal agreements.
Personalized services to support patients receiving approved therapy including insurance coverage assistance, financial assistance options, home delivery of medication, and patient navigation.
Collaborative partnerships for identification, acquisition, and co‑development or licensing of therapeutic programs, including external licensing and global commercialization agreements.
Consideration of support for investigator-initiated clinical studies via provision of investigational drug, funding, or other collaboration under formal agreements.
Personalized services to support patients receiving approved therapy including insurance coverage assistance, financial assistance options, home delivery of medication, and patient navigation.
Expertise Areas
- Clinical trial management
- Oncology drug development
- Antibody–drug conjugates (ADC) development
- Small-molecule kinase inhibitor development
Key Technologies
- Antibody–drug conjugates (ADC)
- Small-molecule kinase inhibitors
- Preclinical tumor models (in vivo efficacy)
- Biomarker-driven patient selection (genomic alterations)
News & Updates
On October 30, 2023, the FDA accepted Day One’s NDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma, with a priority review and PDUFA target date of April 30, 2024.
On September 11, 2023, Day One announced the submission of a rolling NDA to the FDA for tovorafenib in relapsed or progressive pediatric low-grade glioma.
A study presented at ASCO 2025 showing growth recovery in patients after stopping tovorafenib.
Research published online ahead of print in Cancer Research Communications, demonstrating preclinical activity of tovorafenib in tumor models with BRAF fusion or NF1 mutations.
FDA approval of OJEMDA™
In 2024, Day One received FDA approval for OJEMDA™ (tovorafenib) for pediatric brain tumors.
On October 30, 2023, the FDA accepted Day One’s NDA for tovorafenib as a monotherapy in relapsed or progressive pediatric low-grade glioma, with a priority review and PDUFA target date of April 30, 2024.
On September 11, 2023, Day One announced the submission of a rolling NDA to the FDA for tovorafenib in relapsed or progressive pediatric low-grade glioma.
A study presented at ASCO 2025 showing growth recovery in patients after stopping tovorafenib.
Research published online ahead of print in Cancer Research Communications, demonstrating preclinical activity of tovorafenib in tumor models with BRAF fusion or NF1 mutations.
FDA approval of OJEMDA™
In 2024, Day One received FDA approval for OJEMDA™ (tovorafenib) for pediatric brain tumors.