Analyst Andres Y. Maldonado of H.C. Wainwright maintained a Buy rating on Day One Biopharmaceuticals (DAWN – Research Report), with a price target of $50.00.
Andres Y. Maldonado gave his Buy rating based on several factors. One major factor is the FDA’s positive reception to Day One Biopharmaceuticals’s drug, tovorafenib. The FDA has accepted its NDA, granted priority review, and set a PDUFA date for April 30, 2024. The fact that the FDA is not planning an advisory committee meeting to discuss the application indicates that there isn’t any major controversy surrounding the NDA package. Tovorafenib has also been granted Breakthrough Therapy, Rare Pediatric Disease, and Orphan Drug designations by the FDA, further signaling its positive view of the program.
Another positive aspect of tovorafenib is its compelling data package. Recent data from the FIREFLY-1 trial aligns with the bullish outlook, building on the positive profile of tovorafenib. The updated 67% ORR based on RANO-HGG and a clinical benefit rate of 93% in conjunction with a positive safety profile are believed to be strong enough to get the program approved and secure a place as the standard of care for r/pLGG. Furthermore, Maldonado is optimistic about the potential of tovorafenib in treating adult gliomas and other tissue types in 2024. The drug’s profile has become even more attractive considering the perceived tightening of the FDA on single-arm oncology studies. Despite Day One’s stock trading at -48% YTD, Maldonado believes that once the FDA accepts the NDA the stock may show signs of recovery.
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Day One Biopharmaceuticals (DAWN) Company Description:
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.
Read More on DAWN:
- Day One Announces FDA Acceptance of NDA and Priority Review for Tovorafenib in Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
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- Day One Announces Updated FIREFLY-1 Data for Tovorafenib and Completion of Rolling NDA Submission to FDA for Relapsed or Progressive Pediatric Low-Grade Glioma (pLGG)
