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FibroGen Kidney-Disease Drug Set Back as FDA Panel Urges Rejection

An FDA advisory panel recommended against approval of roxadustat, FibroGen's drug for anemia stemming from chronic kidney disease.
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FibroGen  (FGEN) - Get Free Report shares slumped on Friday after an FDA advisory committee recommended against approval for roxadustat, the company’s drug for anemia stemming from chronic kidney disease.

Shares of the San Francisco company recently traded at $15.89, down 36%. It had dropped 43% in the six months through Thursday.

The Food and Drug Administration isn’t required to follow an advisory committee's vote, but it generally does.

“While we are disappointed with today's outcome, we believe the scientific evidence supports roxadustat approval in the U.S. and will work with the FDA as it completes its review of the new drug application,” FibroGen Chief Executive Enrique Conterno said in a statement.

Roxadustat has been approved in China, Japan, Chile, and South Korea.

In other health news this week, the Centers for Medicare and Medicaid Services proposed reimbursement rules that include a 20% cut in physician payments for the Urolift service of medical device company Teleflex  (TFX) - Get Free Report.

UroLift is Teleflex’s system to treat enlarged prostate. The reimbursement guideline applies to procedures performed in doctors’ offices.

The news was a “negative surprise,” said Wells Fargo analyst Shagun Singh, according to Bloomberg. He said 30% of UroLift sales come from doctors’ offices.

To be sure, Piper Sandler analyst Matt O’Brien said, according to Bloomberg, that while the reimbursement move on UroLift is sizable and will hurt doctors' profitability, it shouldn’t greatly curb Teleflex’s revenue and growth rate. He affirmed his overweight rating on the stock.

Meanwhile, Johnson & Johnson  (JNJ) - Get Free Report said Wednesday that it's voluntarily recalling all lots of five spray sunscreen product lines because of benzene presence.