According to the law firm press release, Recro is a specialty pharmaceutical company that develops non-opioid therapeutics for the treatment of pain in the post-operative setting. Recro offers its products to the medical industry. The Company’s lead product is a proprietary injectable form of meloxicam, a long-acting preferential COX-2 inhibitor (“IV meloxicam”) to be used for the management of moderate to severe pain.
The Complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) IV meloxicam lacked supporting clinical data to show sufficient clinical benefits to receive U.S. Food and Drug Administration (“FDA”) approval; and (ii) as a result, Recro’s public statements were materially false and misleading at all relevant times.
On May 24, 2018, Recro announced that the FDA had declined to approve Recro's New Drug Application (“NDA”) for IV meloxicam. In its Complete Response Letter, the FDA stated that the drug's analgesic effects did not meet FDA expectations and raised questions related to chemistry, manufacturing and controls data.
On this news, Recro's share price fell $6.79, or 54.67%, to close at $5.63 on May 24, 2018.