The Next Big Biotech Blow-Up

About: FibroGen, Inc. (FGEN), Includes: AKBA, AZN, GSK
by: Plainview
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FibroGen will reveal pivotal roxadustat safety data Friday (11/8) at ASN 2019.  We believe the data will show significantly higher MACE risk for roxadustat compared to EPO/placebo, precluding US/EU approval.

We compiled all public clinical trial data for roxadustat and found large MACE/death imbalances in favor of control. There were also similar MACE/death imbalances in daprodustat/vadadustat data, suggesting class effect.

Roxadustat needs a 95% confidence interval upper bound of <1.3 to achieve MACE non-inferiority, but published results show the roxadustat MACE incident rate was 9.8x as high as control.

HIF-PH inhibitors are flawed compared to EPO because EPO is specific to erythropoeisis and HIFs are not.  HIFs activate many genes, and are implicated in hypertension, fibrosis, and other adverse effects via erythropoetin-independent mechanisms, driving higher MACE.

We also believe pamrevlumab is worthless.  Pamrevlumab failed in a pancreatic cancer trial, and we believe it has poor commercial prospects in IPF due to clinically irrelevant Phase 3 trial design.

Please see our full presentation here.

Founded in 1993, FibroGen (FGEN) is a $3.7bn pharmaceutical company whose market value stems primarily from its flagship drug roxadustat. Roxadustat is part of a new