Alcobra (ADHD) Stock | FDA Grants Fast Track Status


Alcobra Ltd.  (NASDAQ: ADHD)


Alcobra Ltd. (ADHD), a biopharmaceutical company yesterday announced that the FDA granted fast track designation for their drug Metadoxine Extended Release (MDX). MDX is used for the treatment of Fragile X Syndrome (FXS). FXS is a genetic condition that causes intellectual disability, behavioral and learning challenges. FXS is the leading known genetic cause for autism.  Fast track designation allows for the development process to be expedited and is used when a drug demonstrates a current unmet medical need in serious life threatening diseases or conditions. Companies receiving the fast track designation are often able to bring their product to market a lot faster.


Alcobra Ltd. CEO’s Comments

We are pleased that the FDA has recognized the potential of MDX in Fragile X Syndrome and granted Fast Track designation for this indication,” said Dr. Yaron Daniely, President and Chief Executive Officer of Alcobra. “We look forward to our upcoming meeting with the FDA to determine next steps in advancing the development program for MDX in this area of serious unmet medical need.”  Globe Newswire


ADHD Technical Analysis


ADHD gapped up in price yesterday to $9.14, up from the prior day’s close of $8.26, which is a 11% increase in price based on favorable news.  Taking a look at the daily chart, we can see the last time the stock traded above this price level was back on August 17, when the stock closed at $9.23. On that occasion the stock spiked up from $7.63 on August 12 to the $9.23 price only to go right back down to $7.84 on August 24. Other than that one spike the stock has been in a trading range between $7 and $8 dollars the past couple of months. The stock does have a low float of 5.04 million shares and is trading 1.5 times the normal daily trading volume. Both of these factors make it a good candidate for the gap and go strategy.  The stock did reach pre market highs of $10.14 meaning that it gave back $1.00 at the open equivalent to a 11% decrease in price. This concerns me a bit as it shows the stock may be overextended at these levels. For trading purposes my entry price would be $9.25 looking for a run through $10. My stop loss would be $9.00 fearing anything below that and the stock will fill in the gap up.


Company Profile

Alcobra Ltd., a biopharmaceutical company, focuses on the development and commercialization of oral drug candidates. The company is primarily developing MDX (metadoxine), an onset/extended release formulation of the chemical pyridoxine pyroglutamate, which is in Phase III clinical trial for adults with attention deficit hyperactivity disorder (ADHD); in Phase II clinical trial for pediatric with ADHD; and in Phase II clinical trial in adolescents and adults with Fragile X Syndrome. Alcobra Ltd. was founded in 2008 and is headquartered in Tel Aviv, Israel.  Yahoo Finance