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Day One Biopharmaceuticals

HQ: Brisbane, CA source · dayonebio.com ↗

FDA-approved therapeutic company Clinical Phase 3

Profile checked Oct 10, 2026

Keywords: Low-grade Glioma Melanoma Pilocytic Astrocytoma Non Small Cell Lung Cancer Colorectal Cancer MAP Kinase Family Gene Mutation RAF Mutation Triple Negative Breast Cancer Breast Cancer Endometrial Cancer Ovarian Cancer Fallopian Tube Cancer Primary Peritoneal Cavity Cancer Adenoid Cystic Carcinoma HER2-positive Breast Cancer HER2-positive Gastric Cancer HER2-positive Non-Small Cell Lung Cancer HER2-positive Colorectal Cancer HER2-positive Tumors HER2 Low Breast Cancer Rapidly Accelerated Fibrosarcoma (RAF) Altered Glioma Pediatric Low-grade Glioma CRAF Gene Amplification RAF1 Gene Amplification BRAF Gene Fusion BRAF Fusion CRAF Gene Fusion CRAF Fusion RAF1 Gene Fusion RAF1 Fusion Papillary Thyroid Cancer Spitzoid Melanoma Adult Pilocytic Astrocytoma Non-Small Cell Adenocarcinoma Pancreatic Acinar Carcinoma Spitzoid Malignant Melanoma Bladder Cancer Bladder Urothelial Carcinoma Pancreatic Cancer

8Trials (company is sponsor)1FDA records (2 yrs)

Timeline

  1. FDA FDA New indication / efficacy supplement: OJEMDA (tovorafenib) — NDA217700/2, Aug 27, 2025. Applicant at approval: Day One Biopharmaceuticals, Inc. source ↗
  2. Trial start Phase 1: To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors source ↗
  3. Trial start Phase 3: DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2) source ↗
  4. Trial start Phase 1: A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2 source ↗
  5. Trial start Phase 1/Phase 2: A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid Tumors source ↗
  6. Trial start Phase 1: Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors source ↗
  7. Trial start Phase 2: Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors source ↗
  8. Trial start Phase 2: A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors source ↗

Upcoming milestones

Estimated primary completion per ClinicalTrials.gov. Dates move.

Clinical trials (lead sponsor) 8

RecordTitlePhaseStatusStartPrimary completion
NCT06752681To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid TumorsPhase 1RecruitingNov 18, 20242027-12 (estimated)
NCT05377996A Study of Emiltatug Ledadotin (Emi-Le) in Participants With Solid TumorsPhase 1/Phase 2RecruitingAug 15, 20222027-02 (estimated)
NCT05514717A Study of XMT-2056 in Advanced/Recurrent Solid Tumors That Express HER2Phase 1TerminatedJan 24, 2023May 22, 2026 (actual)
NCT05566795DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)Phase 3Active, not recruitingFeb 27, 20232027-06 (estimated)
NCT04985604Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid TumorsPhase 2TerminatedJul 15, 2021Jul 8, 2024 (actual)
NCT07121829Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid TumorsPhase 1TerminatedMay 2, 2022Dec 18, 2024 (actual)
NCT04775485A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid TumorsPhase 2RecruitingApr 22, 2021May 31, 2027 (estimated)
NCT05760586Expanded Access Program (EAP) for Tovorafenib (DAY101) in RAF-Altered, Relapsed or Refractory Low-Grade GliomaNot listedApproved for marketingNot listedNot listed

FDA records (last 2 years)

Raises and investors new

Form D raises come from the company’s own SEC filing (last 2 years).

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