Al's Comment:

 The HUGE news in this report is the FDA set a PDUFA date of April 30, 2024 for their drug tovorafenib  in relapsed or progressive pLGG.  A PDUFA date is the target date for when the FDA will make a decision on approving the drug or not.  Tovorafenib is an investigational, oral, brain-penetrant, highly selective type II RAF kinase inhibitor designed to target a key enzyme in the MAPK signaling pathway, which is also  being investigated in primary brain tumors or brain metastases of solid tumors. Tovorafenib is currently under evaluation in two pivotal clinical trials for pLGG. Tovorafenib is also being evaluated as a combination therapy for adolescent and adult patient populations with recurrent or progressive solid tumors with MAPK pathway aberrations (FIRELIGHT-1).  


Posted on: 02/27/2024

Day One Reports Fourth Quarter and Full Year 2023 Financial Results and Corporate Progress

 


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