The investigation concerns whether Insmed and certain of its officers and/or directors have violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934.
On June 8, 2016, post-market, Insmed announced that it had withdrawn a European marketing application submitted to the European Medicines Agency ("EMA") for its lung disease drug Arikayce. The Company stated that the marketing application was based on data from a mid-stage clinical study that didn't support enough evidence for an approval from the EMA. Insmed stated that the Company will resubmit the application when data is available from a later study.
On this news, Insmed's share price fell $2.20, or more than 18% to $9.80 in after-hours trading.
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Robert S. Willoughby
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SOURCE Pomerantz LLP