Lawsuit Overview
January 20, 2017 (Shareholders Foundation) - An investor in shares of KemPharm Inc (NASDAQ:KMPH, filed a lawsuit in Iowa over alleged violations of Federal Securities Laws by KemPharm Inc in connection with the company's April 16, 2015 Initial Public Offering.
According to the complaint the plaintiff alleges that the defendants violated Federal Securities Laws in connection with the company's April 16, 2015 Initial Public Offering (“IPO”).
KemPharm Inc conducted its initial public offering in April 2015. Shares of KemPharm Inc (NASDAQ:KMPH) reached as high as $23.63 per share in September 2015.
The plaintiff claims in December 2015, KemPharm Inc submitted a New Drug Application (“NDA”) to the U.S. Food and Drug Administration ( FDA ) for Apadaz.
The plaintiff alleges that Apadaz was intended to be labeled as an abuse-deterrent opioid product that offers equivalent efficacy to the existing standard-of-care products, but with reduced addictive effect and that such labeling would give the drug a competitive advantage in the market for painkillers.
On May 5, 2016, KemPharm Inc announced that the Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee of the FDA had reviewed and voted on Apadaz, determining by a vote of 16 to 4 that Apadaz should be approved for its proposed indication of the management of acute pain that requires an opioid, but voted 18 to 2 against inclusion of abuse deterrent labeling for the product. Shares of KemPharm Inc (NASDAQ:KMPH) declined from $18.53 per share in late April 2016 to as low as $3.69 per share in July 2016.