Supernus Pharmaceuticals, Inc.
|Company Name||Supernus Pharmaceuticals, Inc.|
On November 9, 2020, after the market closed, Supernus disclosed receipt of a complete response letter (“CRL”) from the U.S. Food and Drug Administration (“FDA”) regarding its new drug application (“NDA”) for SPN-812 for the treatment of ADHD in pediatric patients aged 6-17 years old. According to the CRL, the NDA “is not ready for approval in its present form.” Among other things, “[t]he primary issue cited in the SPN-812 CRL relates to the Company’s in-house laboratory that conducts analytical testing, which recently moved to a new location.”
On this news, Supernus’s stock price fell $3.88 per share, or approximately 16%, to close at $21.08 per share on November 10, 2020, thereby injuring investors.
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