Biotech Values

[biomaven0]

>Fibrogen

In terms of safety, there have been over 1k patients on drug already, with no safety signals.

The earlier compound had a single patient with a hepatic event resulting in death. The patient was on multiple other drugs that might have caused the problem, but the FDA suspended both compounds - that caused quite a bit of delay (I'd say nearly 2 years when all the impacts are taken into account). The 2nd gen compound is somewhat more potent, and with hepatic issues, the smaller the absolute dose, the lower the risk. The FDA is not requiring any special hepatic monitoring for the ongoing trials, so I think the chances of this issue recurring are very low.

Efficacy is clear, so the only real risk here is some longer-term safety issue. Key here is that they are going up against Epo, which is not exactly pristine.

Akebia results were not good - efficacy was lower than Fibrogen compound, and a renal tox signal will likely frighten away any partner. And FDA has said you need a cardiac outcomes trial, so that can't be done on the cheap - talking likely $400m at least.

Peter