Day One Biopharmaceuticals (DAWN – Research Report), the Healthcare sector company, was revisited by a Wall Street analyst yesterday. Analyst Alec Stranahan from Bank of America Securities remains neutral on the stock and has a $10.00 price target.
Alec Stranahan’s Sell rating on Day One Biopharmaceuticals’ stock is based on several factors. While the acceptance of their New Drug Application (NDA) for tovorafenib in r/r pLGG is seen as a positive sign, Stranahan highlights that this is not a guaranteed predictor of approval. He points out that there have been instances where companies have received a complete response letter (CRL) without an Advisory Committee (AdCom) or where an AdCom has been announced later in the marketing authorization process. Despite the absence of an AdCom being seen as a positive, Stranahan cautions that it is not the only key determinant for approval and is not sufficient proof of any conclusive judgment.
Furthermore, Stranahan notes that it is not unusual for the FDA to announce an AdCom meeting later than the NDA acceptance date. He provides examples of delayed FDA scheduling of AdCom, reinforcing that it is still possible that the FDA could announce the hosting of an AdCom later on. Additionally, the possibility of receiving a CRL still exists. Stranahan also maintains that while NDA acceptance is a positive development, it does not change his fundamental view due to several unresolved regulatory and statistical concerns that the FDA could challenge. With these issues yet to be addressed, he adopts a conservative stance in anticipation of the FDA review for tovorafenib.
See Insiders’ Hot Stocks on TipRanks >>
TipRanks tracks over 100,000 company insiders, identifying the select few who excel in timing their transactions. By upgrading to TipRanks Premium, you will gain access to this exclusive data and discover crucial insights to guide your investment decisions. Begin your TipRanks Premium journey today.
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)
- Fly Insider: Tango Therapeutics, VMware among week’s notable insider trades
- Avadel Pharmaceuticals added to Conviction List at Needham
- Day One Biopharmaceuticals files automatic mixed securities shelf
- 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)
