FGEN - Does the surprise Adcomm provide a buying oportunity?
Just when you thought you saw it all in terms of FDA review complications, along comes the FDA review of FGEN's Roxadustat (Roxa) in chronic kidney disease. As FGEN appeared to be in the last inning before approval on or before its extended PDUFA date in late March, an AdComm is announced. Not only that, but the AdComm was announced from a different group (cardio-renal) within the FDA than that to which the NDA was submitted (hematology). You can hear a lot more about this on the recent Cowen call ("https://wsw.com/webcast/cowen81/fgen/1931520").
Now the question is whether this significant stock price dip provides an opportunity to get FGEN at a discount. The company has had a roller-coaster stock price since 2017, which can be useful for certain investment strategies. And the current stock price is low entry point. However, on the other hand, the Roxa data analysis is very complex and can be hard to understand, and the FDA results might be a mixed bag even with approval, since FGEN is shooting for 2 indications (CKD in dialysis and CKD in non-dialysis patients) for Roxa. From my perspective, although it might take some patience as FGEN works through these FDA complications, which will likely take more than 3 months if things go well, its current market cap/enterprise value looks attractive. I am a buyer at these levels.
#FGEN, $FGEN, #Roxadustat, #CKD
