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Thursday, September 29, 2016

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%.

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