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AstraZeneca, FibroGen Plan New Roxadustat Filings, But CV Data Confuse Investors

 
• By Sten Stovall

Confusion over top-line pooled cardiovascular Phase III safety data on anemia therapy roxadustat caused shares in AstraZeneca and FibroGen to slide on 9 May, but analysts later said the negative reaction was overdone.

Data
AstraZeneca, FibroGen will start talks soon with the FDA aimed at regulatory submissions of roxadustat • Source: Shutterstock

AstraZeneca PLC and FibroGen Inc. say they are preparing a US filing of roxadustat for anemia in chronic kidney disease in the second half of the year after reporting cardiovascular outcomes data from Phase III trials which analysts said should have been seen as bullish by investors but which instead triggered a sell-off in the duo's shares.

AstraZeneca and FibroGen reported on 9 May an integrated safety analysis that found that roxadustat was less likely to be associated with major adverse cardiovascular events (MACE) than epoetin alfa, a standard therapy for

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