Epizyme (EPZM): Tazemetostat PDUFA Date
First on the docket, Epizyme is looking forward to a PDUFA date on Thursday, Januray 23, 2020. On that day, the FDA will make its decision with regard to Tazemetostat.
If approved Tazemetostat will be indicated for the treatment of various for of hematologic malignancies.
Importnatly, the company has two big things going for it. First and foremost, the FDA granted Priority Review. Not only does this mean that the drug will be reviewed quickly, it means that the drug addresses a problem that has a large, unmet medical need. So, should the drug be approved, it has the ability to quickly become a blockbuster treatment option.
Moreover, the FDA’s Committee Meeting went over incredibly well. In fact, the committee voted in an landslide 11-0 vote to approve the drug. While advisory committees don’t make the final decision to approve or reject new treatment options, their opinions are held very highly by the FDA.
Considering everything available to us, I believe that there is a very strong chance of approval here, which could send the stock soaring.