Alcobra Ltd (NASDAQ:ADHD) investors woke up to a rough morning after the Israeli drug maker disclosed official minutes from its meeting with the Division of Psychiatry Products of the U.S. Food and Drug Administration (FDA) held in early December 2016. The face-to-face meeting was held to discuss the ongoing Clinical Hold for Metadoxine Extended Release (MDX) and paths to resume human clinical trials with MDX.
The official minutes reflect the FDA’s agreement to review the data collected thus far in Alcobra’s Phase 3 MEASURE Study and consider it in a future NDA submission of MDX for treatment of ADHD. The FDA and Alcobra agreed that such an analysis could provide important information with regard to the effectiveness of MDX, as well as information on its safety and tolerability, allowing a more informed discussion of future development activities, as needed. Alcobra has already begun processing the available MEASURE study data and expects to report top-line results for MEASURE in the coming weeks.
The FDA also agreed to modify the Full Clinical Hold to a Partial Hold, pending review and approval of Alcobra’s proposed protocol for a 6-month, Phase 1 clinical study to directly assess the potential relevance of adverse findings observed in long-term, non-clinical (animal) studies of metadoxine with regard to human exposure. The FDA will review results from this safety study and consider the complete lifting of the Full Clinical Hold currently in place on the MDX programs.
Alcobra shares reacted to news, crashing nearly 21% to $1.98 in pre-market trading Monday.
“We are encouraged by this productive meeting with the FDA and the progress made in outlining the development path for a future NDA submission of MDX for treatment of pediatric and adult ADHD,” said Dr. Yaron Daniely, President and CEO of Alcobra. “Our focus now is on analyzing the topline data from MEASURE and working closely with the FDA to resume clinical development activities with the goal of bringing MDX to market for the benefit of patients affected by ADHD or other cognitive disorders.”
On the ratings front, Alcobra has been the subject of a number of recent research reports. In a report issued on November 16, Jefferies analyst Biren Amin reiterated a Buy rating on ADHD, with a price target of $6.00, which implies an upside of 138% from current levels. Separately, on the same day, Barclays’ Douglas Tsao reiterated a Sell rating on the stock and has a price target of $2.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Biren Amin and Douglas Tsao have a yearly average return of 4.7% and 7.7% respectively. Amin has a success rate of 50% and is ranked #831 out of 4350 analysts, while Tsao has a success rate of 55% and is ranked #731.
Overall, one research analyst has rated the stock with a Sell rating, 3 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 $3.30 which is 31% above where the stock closed last Friday.
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.