Ampio Pharmaceuticals (AMPE) Accused of Making Misleading Statements about its Drug Candidate Ampion
One of Ampio Pharmaceuticals’s lead product candidates is Ampion, a biologic intra-articular injection which is being studied for the treatment of pain due to osteoarthritis of the knee. According to the complaint, Ampio made public statements in a press release reporting positive results of Ampio’s Phase 3 trial of Ampion and stated in filings with the Securities and Exchange Commission that “Ampion has consistently demonstrated significant … response across all trials that exceed minimum clinically meaningful threshold.” However, on August 7, 2018, Ampio filed a report on Form 8-K with the SEC revealing that the U.S. Food and Drug Administration (“FDA”) believed that its trial AP-003-A did not appear to provide sufficient evidence of effectiveness to support a Biologics License Application and that the FDA did not consider its AP-003-C trial to be an adequate and well-controlled clinical trial. On this news, the price of Ampio’s stock dropped $2.25 per share, or over 78% from the previous day’s closing price, closing at $0.61 per share on August 8, 2018.
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