=Alcobra Ltd. (ADHD) to merge with Arcturus Therapeutics, Inc.

TEL AVIV, Israel, and SAN DIEGO, Sept. 27, 2017 (GLOBE NEWSWIRE) -- Alcobra Ltd. (NASDAQ:ADHD) and Arcturus Therapeutics, Inc., a privately held biotechnology company developing novel RNA medicines, today announced the signing of a definitive agreement to merge the two companies in an all-stock transaction. The transaction will result in a combined company focused on developing novel RNA medicines in therapeutic areas including infectious disease, cystic fibrosis, nonalcoholic steatohepatitis (NASH) and rare liver diseases.

Following completion of the merger, Alcobra changed its name to Arcturus Therapeutics Ltd.  The combined company will commence trading today on the Nasdaq Global Market under the ticker symbol “ARCT.”

Alcobra Pharma (ADHD) reports that the Phase 3 clinical trial of MDX in adults with ADHD missed the primary endpoint

Alcobra Pharma reports that the Phase 3 clinical trial of MDX in adults with ADHD missed the primary endpoint :

In this trial, MDX did not meet the primary endpoint of demonstrating a statistically significant difference from placebo in the change from baseline of the investigator rating of the Conners' Adult ADHD Rating Scales (:CAARS). As previously communicated, the top-line data analysis was conducted on the Full Analysis Set (n=283), which includes all randomized subjects with at least one post-baseline efficacy assessment. Consistent with previously conducted studies, MDX was generally well tolerated.

• "We are exceedingly disappointed with these top-line results. In the coming weeks, the Company intends to review the full data set from MEASURE. Consequently, we will evaluate our options and communicate our strategic plan to investors"

Alcobra (ADHD) tumbles on FDA clinical hold

Alcobra (ADHD) announced late yesterday that the FDA has placed a clinical hold on its new drug applications for MDX for ADHD treatment.

Alcobra Ltd. (ADHD) saw its shares get halved on Thursday after the U.S. Food and Drug Administration (FDA) placed a clinical hold on its late-stage trial. Specifically, the Division of Psychiatry Products gave a verbal notice that a full clinical hold had been placed on its Investigational New Drug applications for MDX in attention-deficit/hyperactivity disorder (ADHD) and fragile X syndrome.

The clinical hold affects Alcobra’s ongoing Phase 3 clinical study of MDX in adult patients with ADHD, known as the “MEASURE” study.

The company 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 said that it plans to work diligently with the FDA to seek the removal of the clinical hold.

Excluding Thursday’s move, Alcobra has underperformed the broad markets, with the stock down about 26% year to date. Over the past 52 weeks, the stock is down about 22%.