What is Going on with DAWN?
Day One Biopharmaceuticals’ (DAWN) lead product candidate, DAY101, has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration (FDA). Day101 is intended to treat low-grade gliomas harboring an activating RAF alteration, which disproportionately affects children. Pediatric low-grade glioma (pLGG) is rare, but is the most common brain tumor diagnosed in children, and there are currently no approved therapies and standard of care. DAWN stock is up 2.43% to $23.44 per share Tuesday.
Currently, Day One is enrolling patients in a pivotal Phase 2 clinical trial (FIREFLY-1) of DAY101 for adolescent and young adult patient with recurrent or progressive low-grade glioma harboring a known BRAF alteration.
What This Means for DAWN?
Davy Chiodin, PharmD, chief development officer of Day One, states, “Historical approaches to treating pLGG such as surgery, radiation, and chemotherapy are associated with significant acute and life-long adverse effects and new options are urgently needed. DAY101 has the potential to become the first approved treatment option specifically for these patients. Receiving Rare Pediatric Disease Designation from the FDA underscores the critical value of our focus on pediatric indications at Day One, and represents another significant milestone for the DAY101 program as we continue to enroll patients with pLGG in our pivotal Phase 2 FIREFLY-1 study.”
Day One Biopharmaceuticals Inc has a Bullish sentiment reading. Find out what this means for you and get the rest of the rankings on DAWN!
Day One Biopharmaceuticals Inc is a clinical-stage biopharmaceutical company. It is dedicated towards developing and commercializing targeted therapies for patients of all ages with genetically defined cancers. Initially, it focuses on clinical development efforts on pediatric patients living with cancer, a vulnerable population that has been underserved in the recent revolution in targeted therapeutics and immuno-oncology. The lead product candidate, DAY101, is an oral, brain-penetrant, highly-selective type II pan-rapidly accelerated fibrosarcoma, or pan-RAF, kinase inhibitor.
