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0.00158311345646444 -0.0105540897097625 -0.00949868073878627 0.0179419525065965 0.000527704485488209 -0.0474934036939313 0.0453825857519791 0.0849604221635886
Stock impact report

FDA claims Amgen drug data were ‘manipulated'; Erasca slides despite ‘home run' results [Yahoo! Finance]

Erasca, Inc. (ERAS) 
Company Research Source: Yahoo! Finance
Today, a brief rundown of news involving Amgen and Erasca, as well as updates from Rocket Pharma and Janux Therapeutics that you may have missed. The Food and Drug Administration has officially proposed that Amgen withdraw from market Tavneos , a drug the company acquired in a nearly $4 billion deal in 2022 . Amgen disclosed in February that it intended to keep selling Tavneos despite FDA concerns about the drug's clinical results and safety. The FDA stepped up its campaign Monday, publishing a letter to Amgen arguing Tavneos should be pulled because of "new information" showing the drug's approval submissions from former developer ChemoCentryx "contained untrue statements of material fact." According to the agency, "unblinded study personnel manipulated [Tavneos'] results" to make the drug look effective when the original analysis "did not support that conclusion." That initial analysis wasn't disclosed, violating agency regulations, the FDA claimed. Tavneos will remain on the mar Show less Read more
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