TEL AVIV, Israel, Sept. 28, 2016 (GLOBE NEWSWIRE) -- Alcobra Ltd. (NasdaqGM:ADHD), an emerging pharmaceutical company focused on
the development of new medications to treat patients with cognitive disorders, including Attention Deficit Hyperactivity Disorder
(ADHD) and Fragile X Syndrome, today announced that it has received verbal notice from the Division of Psychiatry Products of the
U.S. Food and Drug Administration (FDA) that a full clinical hold has been placed on its Investigational New Drug (IND)
applications for MDX in ADHD and Fragile X Syndrome. The clinical hold affects Alcobra’s ongoing Phase III clinical study of MDX in
adult patients with ADHD, known as the “MEASURE” study.
Alcobra has not yet received written notice of the clinical hold from the FDA, however, based on verbal communications, the FDA
indicated that the clinical hold is due to adverse neurological findings in a pre-clinical study. The FDA notification was not
based on clinical safety data observed in the ongoing MEASURE study, which has enrolled nearly 500 subjects, or previous clinical
studies involving MDX. Alcobra plans to work diligently with the FDA to seek the removal of the clinical hold.
Conference Call Information
Alcobra will host a conference call to discuss today’s announcement.
Thursday, September 29, 2016 @ 8:30 a.m. Eastern
Time
Domestic: 855-469-0611
International: 484-756-4341
Passcode: 91332641
Webcast: http://www.alcobra-pharma.com/events.cfm
Replays available through October 13, 2016
Domestic: 855-859-2056
International: 404-537-3406
Passcode: 91332641
About Alcobra Ltd.
Alcobra Ltd. is an emerging pharmaceutical company primarily focused on the development and commercialization of MDX, a proprietary
drug candidate, to treat cognitive disorders including ADHD and Fragile X Syndrome. For more information, please visit the
company's website, www.alcobra-pharma.com, the content of which is not incorporated herein by reference.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities
Litigation Reform Act of 1995 and other Federal securities laws. Because such statements deal with future events and are based
on Alcobra's current expectations, they are subject to various risks and uncertainties and actual results, performance or
achievements of Alcobra could differ materially from those described in or implied by the statements in this press release. For
example, forward-looking statements include statements regarding the effect of the clinical hold on the Company’s Phase III MEASURE
study and other clinical trials, whether the clinical hold will be released, the content of the official full clinical hold letter
and any deviations of the content of the clinical hold letter, if and when issued, to the information communicated before by the
FDA and content of discussions with the FDA and possible outcomes of such discussions. In addition, historic results of
scientific research do not guarantee that the conclusions of future research would not suggest different conclusions or that
historic results referred to in this press release would not be interpreted differently in light of additional research or
otherwise. The forward-looking statements contained or implied in this press release are subject to other risks and uncertainties,
including those discussed under the heading "Risk Factors" in Alcobra Ltd.'s Annual Report on Form 20-F for the fiscal year ended
December 31, 2015, filed with the Securities and Exchange Commission (SEC) and in subsequent filings with the SEC. Except as
otherwise required by law, Alcobra disclaims any intention or obligation to update or revise any forward-looking statements, which
speak only as of the date they were made, whether as a result of new information, future events or circumstances or
otherwise.
U.S. Investor Contacts LifeSci Advisors, LLC Michael Rice 646-597-6979 mrice@lifesciadvisors.com Media Inquiries Sam Brown, Inc. Mike Beyer 773-463-4211 mikebeyer@sambrown.com Israel Investor Contact: Alcobra Investor Relations Debbie Kaye +972-72 2204661 debbie@alcobra-pharma.com
