One FDA About-Face Doesn’t Mean an Orphan-Drug Bonanza

Sometimes it pays to look a gift horse in the mouth.

For example, take the FDA’s rare course reversal on Tuesday: It let Amicus Therapeutics Inc. seek accelerated approval for rare-disease drug Galafold, after last year saying the biopharma firm would need more data before seeking approval.Amicus shares jumped nearly 26 percent on the news, which could be a positive sign for other drugmakers dealing with tricky FDA issues.

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