FDA reversals leave investors worrying about the fates of other experimental drugs
CNBC
Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.
Investors are concerned about the fates of multiple experimental drugs for hard-to-treat diseases following a string of recent rejections from the U.S. Food and Drug Administration.
The FDA in the past year has denied or discouraged the applications of at least eight drugs, according to RTW Investments, including a gene therapy for Huntington's disease from UniQure, a gene therapy for Hunter syndrome from Regenxbio and a drug for a blood condition from Disc Medicine. The agency initially refused to review Moderna's flu shot before reversing course.
In each case, the FDA took issue with the evidence the companies were using to support their applications. Some of the studies didn't test the drugs against a placebo. Some companies didn't directly measure the drug's efficacy, instead relying on other factors like biomarkers to predict how well the treatment might work.
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Investors are scrutinizing the prospects for some drugs in the pipeline following a string of recent rejections from the U.S. Food and Drug Administration.
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