Biotech Values

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CITI $FGEN We spoke with FGEN mgmt about our note Alert: FGEN: Negative Trend on Cardiac Events and Death Seen with Roxa in Small DD Ph3 Trials in China and Japan.

Mgmt provided the following considerations to add context to the data:

1) Any events that occur in the China and Japan phase 3 trials are not included in the US and Europe ph3 program MACE pools that will be reviewed by FDA and EMA.

2) The China and Japan trials enrolled ~150-300 patients each, and thus have more noise in the data than the ~8,900 patients in the US ph3 program and ~4,700 patients in the Europe ph3 program.

3) The mortality rate for Roxa in clinical trials to date has been lower than expected compared to historical controls. For example, the 1.3% mortality rate in the Roxa arm in the 24-week ph3 Japan dialysis-dependent trial we wrote about in our recent note is a rate of 2.9% per patient-year. For comparison, USRDS data shows that the mortality rate for US Medicare patients with CKD is 12.3% per year.

4) The DSMB has repeatedly reviewed the data from the US & Europe ph3 program and each time recommended continuing trial, suggesting that no major concerns have been seen.

h/t Scott McDowell