Alkermes Public Limited Company (ALKS) Failed to Follow FDA Protocol

According to the complaint, Alkermes Public Limited Company (ALKS) misrepresented its ALKS 5461 New Drug Application ("NDA") success prospects. In its 2017 2Q financial results, Alkermes stated that it had a pre-NDA meeting with the FDA for ALKS 5461, and was on track to complete the submission for the NDA by year-end. In January 2018, Alkermes announced that it had submitted an NDA for ALKS 5461, stating that the NDA submission was "based on a comprehensive clinical efficacy and safety package with data from more than 30 clinical trials and more than 1,500 patients."

Alkermes's 2018 Q1 10-Q filed on April 26, 2018, reassured investors that the NDA was on track even after the FDA rescinded its refusal to file letter. However, an FDA briefing document released in October revealed to the public that Alkermes had failed to disclose that it had disregarded the protocol the FDA had advised in connection with its NDA submission for ALKS 5461. As a result, an FDA advisory committee voted 21 to 2 against the approval of ALKS 5461. Since questions about the viability of ALKS 5461 have surfaced, Alkermes stock has declined almost 50%.

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