FibroGen (FGEN) Steals the Show at ASN, Bodes Well for Upcoming PDUFA - Stifel

Stifel analyst Annabel Samimy reiterated a Buy rating on FibroGen (NASDAQ: FGEN) after Roxadustat had an extensive presence at ASN Kidney Week. The highlight was the competitive profile and versatility of this new anemia-correcting agent (HIF-PHI) across multiple CKD patient types. The analyst believes that Roxadustat sets a high bar for any future competitor, increasing confidence in the 12/20/20 PDUFA and the likelihood of strong market adoption.

The analyst stated "Contrary to the Black Box with standard EPO that warns of increased risk of CV events at hemoglobin levels of ≥11g/dL (approaching desired non-anemic levels), the late-breaker presentations highlight the opposite. In both dialysis-dependent (DD) and non-dialysis-dependent (NDD), the MACE/MACE+ safety improved as hemoglobin levels increased, with the lowest incidence occurring at levels ≥11g/dL and ≥12g/dL (most dramatic for CV death, hospitalization for CHF, and hypertensive emergency). Recall, the increased CV risk of ESAs limited hemoglobin levels to suboptimal levels".

For an analyst ratings summary and ratings history on FibroGen click here. For more ratings news on FibroGen click here.

Shares of FibroGen closed at $45.61 yesterday.

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