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On August 6, 2019, the United States Food and Drug Administration (“FDA”) issued a statement revealing data manipulation in connection with the May 2019 approval of Novartis’ gene therapy drug, Zolgensma. According the the statement, AveXis Inc., a subsidiary of Novartis and the product’s manufacturer, “became aware of the issue of the data manipulation that created inaccuracies in their [biologics license application] before the FDA approved the product, yet did not inform the FDA until after the product was approved”. The FDA’s continuing investigation may lead to penalties for Novartis, and the Company’s share price has already fallen significantly.