- Company Name
- Alkermes plc
- Stock Symbol
- Class Period
- February 17, 2017 to November 1, 2018
- Motion Deadline
- February 25, 2019
- Eastern District of New York
The complaint charges Alkermes and certain of its officers with violations of the Securities Exchange Act of 1934. Alkermes is a biopharmaceutical company focused on the development of treatments for central nervous system disorders such as addiction, schizophrenia, depression and diabetes. One of Alkermes lead product candidates is ALKS 5461, a proprietary investigational drug in development for the adjunctive treatment of Major Depressive Disorder, or MDD, in patients with an inadequate response to standard antidepressant therapies.
In February 2017, Alkermes announced it had met with the FDA regarding ALKS 5461 and planned to submit a New Drug Application (“NDA”) for the drug in the second half of 2017. In January 2018, Alkermes announced it had submitted its NDA for ALKS 5461, stating that the NDA was “based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients with MDD. Throughout the clinical development program, ALKS 5461 demonstrated a consistent profile of antidepressant activity, safety and tolerability in the adjunctive treatment of MDD.”
The complaint alleges that during the Class Period, defendants made false and misleading statements and/or failed to disclose adverse information regarding Alkermes’ business and the prospects for its drug candidate ALKS 5461. Specifically, defendants concealed that the Company had failed to follow a specific protocol the FDA had advised it to follow in connection with its NDA submission for ALKS 5461, which would foreseeably result in the FDA advisory committee voting against approval of ALKS 5461. As a result of this information being withheld from the market, Alkermes shares traded at artificially inflated prices, reaching a high of $67.26 per share during the Class Period.
On April 2, 2018, Alkermes reported that it had received a Refusal to File letter from the FDA regarding its NDA for ALKS 5461. The Company stated that “the FDA has taken the position that it is unable to complete a substantive review of the regulatory package, based on insufficient evidence of overall effectiveness for the proposed indication, and that additional well-controlled clinical trials are needed prior to the resubmission of the NDA for ALKS 5461.” As a result of this news, the Company’s shares dropped $12.73 per share to close at $43.23 per share on April 2, 2018, a decline of nearly 22%.
Then on November 1, 2018, Alkermes announced that the FDA advisory committee had voted 21 to 2 against approval of ALKS 5461. The same day, Xconomy reported that “[a]t the hearing, FDA representatives said the agency specifically told Alkermes not to analyze its data through an average, which it still did.” On this news, the price of Alkermes shares fell $3.09 per share, or over 7.5%, to close at $37.74 per share on November 2, 2018.