Recro Pharma, Inc.
- Company Name
- Recro Pharma, Inc.
- Stock Symbol
- Class Period
- July 31, 2017 to May 23, 2018
- Motion Deadline
- July 30, 2018
- Eastern District of Pennsylvania
The complaint charges Recro and certain of its officers with violations of the Securities Exchange Act of 1934. Recro is a specialty pharmaceutical company that develops non-opioid therapeutics for the treatment of pain in the post-operative setting. 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. Recro announced the submission of its New Drug Application (“NDA”) for IV meloxicam to the U.S. Food and Drug Administration (“FDA”) on July 31, 2017.
The complaint alleges that throughout the Class Period, defendants made materially false and misleading statements and/or failed to disclose adverse information regarding the Company’s business and prospects. Specifically, despite defendants’ positive statements during the Class Period regarding the prospects for FDA approval of IV meloxicam, including that the NDA for IV meloxicam was “supported by positive results from two pivotal Phase III clinical efficacy trials” and a “large double-blind Phase III safety trial,” IV meloxicam lacked supporting clinical data to show sufficient benefits to receive FDA approval. As a result of defendants’ false statements and/or omissions, Recro securities traded at artificially inflated prices during the Class Period, with its stock price reaching a high of more than $12 per share.
On May 24, 2018, Recro announced that the FDA had declined to approve its 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, the price of Recro stock fell $6.79 per share, or more than 54%, to close at $5.63 per share on May 24, 2018.