Ampio Pharmaceuticals, Inc.
- Company Name
- Ampio Pharmaceuticals, Inc.
- Stock Symbol
- Class Period
- December 14, 2017 to August 7, 2018
- Motion Deadline
- October 24, 2018
- Central District of California
The complaint charges Ampio and certain of its officers with violations of the Securities Exchange Act of 1934. Ampio is a biopharmaceutical company that focuses on the development of therapies for the treatment of inflammatory conditions. One of the Company’s lead product candidates is Ampion, a biologic intra-articular injection being studied for the treatment of pain due to osteoarthritis of the knee.
During the Class Period, Ampion was being studied as a treatment for severe osteoarthritis of the knee in two Phase 3 clinical trials known as AP-003-A and AP-003-C. According to the Company, it was required by the FDA to conduct two pivotal trials in support of its Biologics License Application (“BLA”) submission for Ampion. In its presentation regarding Ampion, Ampio represented that the FDA had previously designated the AP-003-A trial as a pivotal trial and Ampio believed the AP-003-C study would serve as the second pivotal trial in support of the Company’s BLA for the drug.
The complaint alleges that during the Class Period, defendants made false and misleading statements and/or failed to disclose adverse information regarding the prospects for Ampion. Specifically, contrary to defendants’ positive statements during the Class Period, including that the “Phase 3 clinical trial of Ampion met its primary endpoint” and that Ampio was looking “forward to working closely with the [FDA] as [it] prepare[s] to submit [its] Biologics License Application (BLA),” the FDA would find Ampio’s AP-003-C Phase 3 clinical trial inadequate and not well-controlled and, as a consequence, Ampio would fail to successfully complete the two pivotal clinical trials for Ampion required by the FDA. As a result of defendants’ false statements and/or omissions, Ampio securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $4 per share.
Then on August 7, 2018, after the market closed, Ampio issued an update regarding the AP-003 trials for Ampion. The Company disclosed that, while it had met with the FDA in July 2018 and received a letter in response to the meeting stating that the FDA considered the AP-003-A trial “to be an adequate and well controlled clinical trial,” “as a single trial the AP-003-A study alone does not appear to provide sufficient evidence of effectiveness to support a BLA.” The Company further stated that despite its “belief that the APC-003-C trial design was based on FDA guidance and feedback and [was] consistent with FDA precedent for similar products . . . , the FDA does not consider the AP-003-C trial to be an adequate and well-controlled clinical trial.” On this news, the price of Ampio shares fell $2.25 per share, or over 7%, to close at $0.61 per share on August 8, 2018, and continued to fall another 21% the following day.