Robbins Arroyo LLP: Alkermes Public Limited Company (ALKS) Misled Shareholders According to a Recently Filed Class Action

Shareholder rights law firm Robbins Arroyo LLP announces that purchasers of Alkermes Public Limited Company (NASDAQ: ALKS) filed a class action complaint against the company for alleged violations of the Securities and Exchange Act of 1934 between February 17, 2017 and November 1, 2018. Alkermes, a biopharmaceutical company, researches, develops, and commercializes pharmaceutical products.

View this information on the law firm's Shareholder Rights Blog: https://www.robbinsarroyo.com/alkermes-public-limited-company/

Alkermes Failed to Follow FDA Protocol

According to the complaint, Alkermes 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Alkermes's 2018 Q1 10-Q filed on April 26, 2018, reassured investors that the NDA was on track even after the FDA rescinded its refusal to file letter.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%.

Alkermes Shareholders Have Legal Options

Concerned shareholders who would like more information about their rights and potential remedies can contact attorney Leo Kandinov at (800) 350-6003, LKandinov@robbinsarroyo.com, or via the shareholder information form on the firm's website.

Robbins Arroyo LLP is a nationally recognized leader in shareholder rights law. The firm represents individual and institutional investors in shareholder derivative and securities class action lawsuits, and has helped its clients realize more than $1 billion of value for themselves and the companies in which they have invested.

Attorney Advertising. Past results do not guarantee a similar outcome.

View source version on businesswire.com: https://www.businesswire.com/news/home/20190108005872/en/