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Day One Biopharmaceuticals (DAWN)
NASDAQ:DAWN
Tovorafenib, Tovorafenib Drug: Pimasertib
Melanoma, Colorectal Cancer, Non Small Cell Lung Cancer, Pancreatic Cancer, Solid Tumor, Pilocytic Astrocytoma, Map Kinase Family Gene Mutation, Ras Mutation, Raf Mutation, Mek Mutation
Phase I
Terminated
Tovorafenib (DAY101) or in Combination With Pimasertib for Participants With Melanoma and Other Solid Tumors
Jul 03, 2025
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Day301
Advanced Or Metastatic Solid Tumors
Phase I
Recruiting
To Evaluate the Safety, Tolerability, Pharmacokinetics and Antitumor Activity of DAY301 in Participants With Locally Advanced or Metastatic Solid Tumors
Dec 23, 2024
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Tovorafenib, Chemotherapeutic Agent
Low-Grade Glioma, Rapidly Accelerated Fibrosarcoma (Raf) Altered Glioma, Pediatric Low-Grade Glioma
Phase III
Recruiting
DAY101 vs. Standard of Care Chemotherapy in Pediatric Participants With Low-Grade Glioma Requiring First-Line Systemic Therapy (LOGGIC/FIREFLY-2)
Sep 16, 2022
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Tovorafenib
Bladder Cancer, Melanoma, Colorectal Cancer, Non Small Cell Lung Cancer, Solid Tumor, Bladder Urothelial Carcinoma, Pilocytic Astrocytoma, Map Kinase Family Gene Mutation, Raf Mutation, Non-Small Cell Adenocarcinoma, Craf Gene Amplification, Raf1 Gene Amplification, Braf Gene Fusion, Braf Fusion, Craf Gene Fusion, Craf Fusion, Raf1 Gene Fusion, Raf1 Fusion, Thyroid Cancer, Papillary, Spitzoid Melanoma, Pilocytic Astrocytoma, Adult, Pancreatic Acinar Carcinoma, Spitzoid Malignant Melanoma
Phase II
Terminated
Tovorafenib (DAY101) Monotherapy for Patients With Melanoma and Other Solid Tumors
Jun 23, 2021
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Tovorafenib
Advanced Solid Tumor, Low-Grade Glioma
Phase II
Recruiting
A Study to Evaluate Tovorafenib in Pediatric and Young Adult Participants With Relapsed or Progressive Low-Grade Glioma and Advance Solid Tumors
Feb 03, 2021
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FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Day One Biopharmaceuticals (DAWN) have in its pipeline
DAWN is currently developing the following drugs: Tovorafenib, Tovorafenib Drug: Pimasertib, Day301, Tovorafenib, Chemotherapeutic Agent. These drug candidates are in various stages of clinical development as the company works toward FDA approval.