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FibroGen Plunges On Murky Safety Disclosure For Controversial Drug

FibroGen stock plummeted late Tuesday on a murky disclosure for its controversial anemia treatment in chronic kidney disease patients.




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While preparing for an advisory committee meeting ahead of potential approval of its drug, roxadustat, FibroGen (FGEN) said it realized it submitted altered information to the Food and Drug Administration pertaining to the drug’s cardiovascular safety.

Now, FibroGen says the new data suggest roxadustat might not be superior to another drug called epoetin-alfa in lowering the risk of cardiovascular events in some patients.

In late action on the stock market today, FibroGen stock plunged 23.2% near 26.60. Shares closed the regular session down 2.8% at 34.64.

FibroGen Stock Falls, Review Begins

The analysis doesn’t change Fibrogen’s view that roxadustat is comparable to epoetin-alfa in dialysis-dependent patients, the company said in a news release.

“There is no change in the underlying roxadustat data, or to the (effectiveness) analyses from the Phase 3 program,” FibroGen said. The company has begun a comprehensive internal review to ensure such issues do not occur in the future.”

FibroGen is collaborating on the development and commercialization of roxadustat with AstraZeneca (AZN) and Astellas in specific locations.

Follow Allison Gatlin on Twitter at @IBD_AGatlin.

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