NEW YORK, Jan. 8, 2019 /PRNewswire/ -- Kaplan Fox & Kilsheimer LLP (www.kaplanfox.com) is investigating claims on behalf of investors of Alkermes plc ("Alkermes" or the "Company") (NASDAQ: ALKS). Investors who purchased Alkermes securities between February 17, 2017 and November 1, 2018, inclusive (the "Class Period") may be affected. A complaint has been filed in the United States District Court for the Eastern District of New York against Alkermes, the Company's Chairman and CEO, and its CFO on behalf of investors of Alkermes securities during the Class Period.
On October 30, 2018, ahead of a scheduled Food and Drug Administration ("FDA") advisory committee meeting, the FDA released a briefing document concerning Alkermes' New Drug Application ("NDA") for ALKS 5461 being developed for Major Depressive Disorder ("MDD"). The FDA briefing document revealed that in September 2016, Alkermes had submitted an amendment to its study protocol to use an abridged 6-item version of the 10-item diagnostic Montgomery Asberg Depression Rating Scale, or MADRS-10, used to measure the severity of depressive episodes in patients with mood disorders. According to the briefing document, these changes were discussed during a February 13, 2017 meeting with the FDA, and in advance of the meeting the FDA provided advice explicitly against the plan to use the abridged 6-item version of MADRS-10. Among other things, the FDA warned that "[i]n general, we do not accept major changes, such as revising primary efficacy measures, in the late stage of a clinical trial" and "[w]e have not previously accepted the MADRS-6 as a primary efficacy endpoint for a clinical trial."
Additionally, according to the FDA briefing document, Alkermes was also warned prior to the February 13, 2017 meeting that "[w]e do not agree with the strategy of comparing the baseline MADRS-6 or MADRS-10 scores to the average of the scores from Week 3 to the end of the efficacy period" and "[w]e recommend using a single efficacy measure at the end of the study and not an average over multiple time periods, as the primary efficacy endpoint."
Following this news, the price of Alkermes shares fell $0.57 per share, about 1.4%, to close at $39.80 per share on October 30, 2018.
Then, on November 1, 2018, the FDA advisory committee voted 21 to 2 against approval of ALKS 5461. Reportedly, at the hearing, FDA representatives said the agency had specifically told Alkermes not to analyze its data through an average, which it did anyway.
Following 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.
If you are a member of the proposed Class, you may move the court no later than February 25, 2019 to serve as a lead plaintiff for the purported class. You need not seek to become a lead plaintiff in order to share in any possible recovery. If you would like to discuss the complaint or our investigation, please contact us by emailing [email protected] or by calling 800-290-1952.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com. If you have any questions about this Notice, the action, your rights, or your interests, please contact:
Jeffrey P. CampisiKAPLAN FOX & KILSHEIMER LLP850 Third Avenue, 14th FloorNew York, New York 10022(800) 290-1952(212) 687-1980Fax: (212) 687-7714E-mail: [email protected]
Laurence D. KingKAPLAN FOX & KILSHEIMER LLP350 Sansome Street, Suite 400 San Francisco, California 94104(415) 772-4700Fax: (415) 772-4707E-mail: [email protected]
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On October 30, 2018, ahead of a scheduled Food and Drug Administration ("FDA") advisory committee meeting, the FDA released a briefing document concerning Alkermes' New Drug Application ("NDA") for ALKS 5461 being developed for Major Depressive Disorder ("MDD"). The FDA briefing document revealed that in September 2016, Alkermes had submitted an amendment to its study protocol to use an abridged 6-item version of the 10-item diagnostic Montgomery Asberg Depression Rating Scale, or MADRS-10, used to measure the severity of depressive episodes in patients with mood disorders. According to the briefing document, these changes were discussed during a February 13, 2017 meeting with the FDA, and in advance of the meeting the FDA provided advice explicitly against the plan to use the abridged 6-item version of MADRS-10. Among other things, the FDA warned that "[i]n general, we do not accept major changes, such as revising primary efficacy measures, in the late stage of a clinical trial" and "[w]e have not previously accepted the MADRS-6 as a primary efficacy endpoint for a clinical trial."
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Additionally, according to the FDA briefing document, Alkermes was also warned prior to the February 13, 2017 meeting that "[w]e do not agree with the strategy of comparing the baseline MADRS-6 or MADRS-10 scores to the average of the scores from Week 3 to the end of the efficacy period" and "[w]e recommend using a single efficacy measure at the end of the study and not an average over multiple time periods, as the primary efficacy endpoint."
Following this news, the price of Alkermes shares fell $0.57 per share, about 1.4%, to close at $39.80 per share on October 30, 2018.
Then, on November 1, 2018, the FDA advisory committee voted 21 to 2 against approval of ALKS 5461. Reportedly, at the hearing, FDA representatives said the agency had specifically told Alkermes not to analyze its data through an average, which it did anyway.
Following 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.
If you are a member of the proposed Class, you may move the court no later than February 25, 2019 to serve as a lead plaintiff for the purported class. You need not seek to become a lead plaintiff in order to share in any possible recovery. If you would like to discuss the complaint or our investigation, please contact us by emailing [email protected] or by calling 800-290-1952.
This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.
Kaplan Fox & Kilsheimer LLP, with offices in New York, San Francisco, Los Angeles, Chicago and New Jersey, has many years of experience in prosecuting investor class actions. For more information about Kaplan Fox & Kilsheimer LLP, you may visit our website at www.kaplanfox.com. If you have any questions about this Notice, the action, your rights, or your interests, please contact:
Jeffrey P. CampisiKAPLAN FOX & KILSHEIMER LLP850 Third Avenue, 14th FloorNew York, New York 10022(800) 290-1952(212) 687-1980Fax: (212) 687-7714E-mail: [email protected]
Laurence D. KingKAPLAN FOX & KILSHEIMER LLP350 Sansome Street, Suite 400 San Francisco, California 94104(415) 772-4700Fax: (415) 772-4707E-mail: [email protected]
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SOURCE Kaplan Fox & Kilsheimer LLP
