FibroGen announces positive Ph3 data for roxadustat in Chronic Kidney Disease (CKD)


This morning FibroGen Inc. (FGEN), reported results from two Ph3 trials evaluating roxadustat in non-dialysis dependent (NDD) and dialysis dependent (DD) CKD. In the NDD-CKD trial, roxadustat was compared against placebo and achieved a pre-defined hemoglobin (Hb) response (increase >1g/dL from baseline) in 84% of patients compared to 0% in placebo. For the DD-CKD trial, patients were randomized to either continue the standard of care (epoetin alpha) or convert to roxadustat. The endpoint was to establish non-inferiority upon conversion. The roxadustat patients actuallyachieved superior levels of Hb (p=0.037). Furthermore, it is notable that there were no adverse events reported. According to management, “Full details of data are expected in due course”. As a reminder, this program is partnered out to Astellas and Astra Zeneca, deals that included ~$2.5B in milestone payments and downstream royalties in the low to mid 20% range.

We are not surprised that today’s positive news has not significantly positively impacted FGEN’s stock price because the stock has been gradually increasing over the past few quarters and the high likelihood of success of these trials were already somewhat priced into the stock. However, we continue to feel the FGEN is attractively priced and like the stock long-term, which is further underscored by today’s positive results for their most advanced asset.

FibroGen, Inc. is one of AMP Biotech Research's quarterly picks for Q1 2017. AMP is a biotech research firm that publishes a quarterly list of companies with attractive valuations and near-term catalysts. To see all of AMP's picks for Q1 2017, go to www.ampbioresearch.com.

Find the press release here: http://investor.fibrogen.com/phoenix.zhtml?c=253783&p=irol-newsArticle&ID=2240513

Seeking Alpha article here: http://seekingalpha.com/article/4039292-fibrogen-set-big-year


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