Thursday turned out to be a nightmare for shareholders of Alcobra Ltd (NASDAQ:ADHD), after the ADHD drug maker announced that it has received verbal notice from the Division of Psychiatry Products of the 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 shares reacted to the news, crashing nearly 55% to $2.07 in early trading.
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. (Original Source)
On the ratings front, Alcobra has been the subject of a number of recent research reports. In a report released today, Cantor analyst Mara Goldstein reiterated a Buy rating on ADHD, with a price target of $16, which implies an upside of 631% from current levels. Separately, on the same day, Oppenheimer’s Jay Olson downgraded the stock to Hold .
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Mara Goldstein and Jay Olson have a total average return of 2.9% and 42.0% respectively. Goldstein has a success rate of 43% and is ranked #1044 out of 4181 analysts, while Olson has a success rate of 60% and is ranked #903.
Overall, one research analyst has rated the stock with a Sell rating, 2 research analysts have assigned a Hold rating and 2 research analysts have given a Buy rating to the stock. When considering if perhaps the stock is under or overvalued, the average price target is $9.33 which is 326% above where the stock opened today.
Alcobra Ltd. engages in the research, development, and market of pharmaceutical productsfor the treatment of central nervous system disorders and cognitive dysfunctions. Its portfolio includes Metadoxine Extended Release to treat Attention Deficit Hyperactivity Disorder and Fragile X Syndrome.