UPDATE: H.C. Wainwright Starts FibroGen (FGEN) at Buy
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H.C. Wainwright initiates coverage on FibroGen (NASDAQ: FGEN) with a Buy rating, PT $58.00.
The analyst comments "We initiate coverage of FGEN shares with a Buy and $58 price target. Roxa is currently under final FDA review (PDUFA date of March 20, 2021) for the treatment of anemia associated with chronic kidney disease (CKD). We believe roxa is likely to gain approval in the US (and later EU) and may be broadly used in both dialysis dependent (DD) and non-dialysis dependent (NDD) CKD patients. We assume there could be some benign safety warnings on the roxa label (e.g. hemoglobin target), but they should have little impact to roxa’s uptake especially in DD CKD market, given roxa’s differentiated clinical profile from ESAs. We model roxa worldwide peak sales of $2.5 billion (FY29), which translates into $600 million of royalty (and profit share) to FGEN. We are bullish on pamrevlumab’s opportunity in idiopathic pulmonary fibrosis (IPF) given its solid Phase 2 results, but acknowledge that Ph3 results and potential approval are still years away due to enrollment delay and Covid-19 impact. Currently, our conservative valuation does not assign values to roxa in CIA (Ph2) and MDS (Ph3) and Pamrevlumab in DMD (Ph3) as we await more clinical data and timeline clarity. We believe the positive development of these clinical programs could bring considerable upside to FGEN shares."
Shares of FibroGen closed at $48.18 yesterday.
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Create E-mail Alert Related CategoriesAnalyst Comments, New Coverage
Related EntitiesPDUFA, H.C. Wainwright, FDA
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