|Clinical and Regulatory|
|Event Type:||NDA Submission|
|Designation(s):||Fast Track, Orphan Drug|
This event is set for a broad date range and therefore the exact timing is unknown. This adds a degree of risk.
|Disease and Treatment|
|Indication:||Acute Myeloid Leukemia|
|Treatment Name:||Enasidenib (AG-221)|
Likelihood of event success varies depending on disease, treatment and lead indication classification.
|Co. Name:||Agios Pharmaceuticals|
The OTC BB and OTC Markets have less stringent reporting and financial requirements than the NASDAQ and NYSE. This may increase the level of risk for investors. Smaller size may have an influence on likelihood of success.
Partnerships help smaller biotech companies finance the long approval process. Partnership also provides validation the clinical program may be a worthy investment.
Detailed Event Description from Company Announcement
Agios Pharmaceuticals, Inc. (the “Company”) today announced that its collaboration partner Celgene Corporation (“Celgene”) expects to submit a new drug application (“NDA”) to the U.S. Food and Drug Administration (“FDA”) for enasidenib (AG-221), a first-in-class, oral, selective, potent inhibitor of mutant isocitrate dehydrogenase-2 (“IDH2”), in relapsed and/or refractory acute myeloid leukemia (“AML”). The NDA will be based on data from the ongoing phase 1/2 study of AG-221 in patients with advanced hematologic malignancies with an IDH2 mutation. The NDA submission is expected to occur by year-end 2016. Celgene will be discussing the planned enasidenib NDA submission at the Citi 11th Annual Biotech Conference in Boston in a webcast event on Wednesday, September 7, 2016 at 12:00 pm ET